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Sample records for resistant insomnia post-marketing

  1. Insomnia

    Science.gov (United States)

    ... the death or illness of a loved one, divorce, or a job loss — also may lead to ... insomnia associated with medications. Insomnia in children and teens Sleep problems may be a concern for children ...

  2. Safety and efficacy of a novel drug elores (ceftriaxone + sulbactam + disodium edetate in the management of multi-drug resistant bacterial infections in tertiary care centers: a post-marketing surveillance study

    Directory of Open Access Journals (Sweden)

    Manu Chaudhary

    2017-07-01

    Conclusion: In this post-marketing surveillance study, CSE-1034 was found to be an effective and safe option against Pip tazo and meropenem in management of patients with multi-drug resistant (MDR bacterial infections under routine ward settings.

  3. Hypersomnolence, insomnia and the pathophysiology of upper airway resistance syndrome.

    Science.gov (United States)

    Gold, Avram R; Gold, Morris S; Harris, Keith W; Espeleta, Vidal J; Amin, Mohammad M; Broderick, Joan E

    2008-08-01

    In order to test the hypothesis that upper airway resistance syndrome (UARS) is merely an extension of the pathophysiology of obstructive sleep apnea/hypopnea (OSA/H) to less severe pharyngeal collapse during sleep, we compared the severity of hypersomnolence and the prevalence of insomnia in UARS patients to the patterns observed for OSA/H patients. Our goal was to determine whether the severity of hypersomnolence and the prevalence of insomnia observed in UARS patients could have been predicted from the patterns observed among OSA/H patients. We performed a retrospective study of a large consecutive patient series evaluated at an academic sleep disorders center, including 220 OSA/H patients and 137 UARS patients. Patients had no other sleep-related diagnosis and underwent an initial evaluation that included a measure of hypersomnolence [a multiple sleep latency test (MSLT); 95%] or insomnia questionnaire (87%). Patients were characterized by anthropometric data, polysomnographic descriptive measures of sleep, MSLT data and insomnia questionnaire data. Severity of hypersomnolence decreased over the continuum from severe to mild OSA/H. A model fit to the OSA/H patients to predict severity of hypersomnolence significantly underestimated hypersomnolence in UARS patients, which was comparable in severity to that of patients with mild OSA/H. The frequency of sleep-onset insomnia increased over the continuum from severe to mild OSA/H and increased further in UARS. UARS is, in some respects, an extension of OSA/H to less severe pharyngeal collapse, but this does not adequately account for the symptom profile of patients with UARS. A physical model is proposed to account for the excess somnolence in UARS relative to expectations and the increasing frequency of sleep-onset insomnia along the continuum from severe OSA/H to UARS.

  4. Insomnia

    Science.gov (United States)

    ... may get too little sleep or have poor-quality sleep. You may not feel refreshed when you wake ... You may have trouble focusing on tasks, paying attention, learning, and remembering. Insomnia ... for your sleep history. Your provider will ask you for details ...

  5. Insomnia

    Science.gov (United States)

    ... American Academy of Sleep Medicine clinical practice guideline. Journal of Clinical Sleep Medicine. 2017;13:307. Jan. 30, 2018 Original article: http://www.mayoclinic.org/diseases-conditions/insomnia/in-depth/sleeping-pills/ART-20043959 . Mayo Clinic Footer Legal Conditions and Terms ...

  6. Safety and efficacy of a novel drug elores (ceftriaxone+sulbactam+disodium edetate) in the management of multi-drug resistant bacterial infections in tertiary care centers: a post-marketing surveillance study.

    Science.gov (United States)

    Chaudhary, Manu; Mir, Mohd Amin; Ayub, Shiekh Gazalla

    In India, Elores (CSE-1034: ceftriaxone+sulbactam+disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections and identify the incidence of adverse events in real clinical settings. This Post Marketing Surveillance study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with Elores (CSE1034). Information regarding demographic, clinical and microbiological parameters, dosage and treatment duration, efficacy and adverse events (AEs) associated with the treatment were recorded. A total of 2500 patients were included in the study and efficacy was evaluated in 2487 patients. In total, 409 AEs were reported in 211 (8.4%) patients. The major AEs reported were vomiting (3.0%), pain at injection site (2.5%), nausea (2.3%), redness at site (1.96%), thrombophlebitis (1.4%). Of total reported AEs, 40 (5.3%) AEs were reported in pediatric, 310 (20.6%) in adult, and 59 (23.6%) in geriatric group. No AE belonging to grade IV or V was reported in any patient. In terms of efficacy, 1977 (79.4%) patients were cured, 501 (20.1%) patients showed clinical improvement and 5 (0.2%) patients were complete failure. The treatment duration varied from 5 to 7 days in different patients depending on the infection type. In this post-marketing surveillance study, CSE-1034 was found to be an effective and safe option against Pip tazo and meropenem in management of patients with multi-drug resistant (MDR) bacterial infections under routine ward settings. Copyright © 2017 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

  7. Insomnia - overview

    Science.gov (United States)

    ... adults. Poor sleep or lifestyle habits that may cause insomnia or make it worse include: Going to bed ... including: Bipolar disorder . Feeling sad or depressed. (Often, insomnia is the symptom that causes people with depression to seek medical help.) Stress ...

  8. Registries in European post-marketing surveillance

    DEFF Research Database (Denmark)

    Bouvy, Jacoline C; Blake, Kevin; Slattery, Jim

    2017-01-01

    PURPOSE: Regulatory agencies and other stakeholders increasingly rely on data collected through registries to support their decision-making. Data from registries are a cornerstone of post-marketing surveillance for monitoring the use of medicines in clinical practice. This study was aimed...... for a registry was made as a condition of the marketing authorisation. All centrally authorised products that received a positive opinion of the EMA Committee for Medicinal Products for Human Use between 1 January 2005 and 31 December 2013 were included. Data regarding registry design and experiences were...... registries and 71% of the registries had a primary safety objective. Most commonly reported issues with registries were delayed time to start and low patient accrual rates. CONCLUSIONS: The delays found in getting new registries up and running support the need to improve the timeliness of data collection...

  9. Post-marketing surveillance of buprenorphine.

    Science.gov (United States)

    Ray, Rajat; Pal, Hemraj; Kumar, Rajesh; Maulick, Pallab; Mangla, R

    2004-09-01

    This study was undertaken to evaluate the adverse consequences of recently introduced higher strength (0.4 and 2.0 mg per tablet) buprenorphine in Indian market. Buprenorphine, a partial opiate agonist and antagonist, is an emerging alternative to methadone as an agent for long-term treatment of opiate dependence. The current investigation was conducted through a multi-centric post-marketing surveillance (PMS) study using a structured performa from patients receiving buprenorphine as routine therapy from de-addiction centres. Evaluation included subjective and objective assessments and recording of adverse events. Of the 5551 observations from ten centres, common subjective symptoms were generalised weakness (48.9%), sense of high (euphoria) (44.5%), muscle aches (39.5%) and relief from pain (37.2%). About 5% observations recorded systolic hypertension. Among 55 subjects where laboratory tests were conducted, 12 showed raised levels of AST ad 9 had elevated ALT. Twelve adverse events reported included seizure, epistaxis, panic attacks, constipation and dyspnoea. Significant relation was seen between duration of use and time since last dose, and total number of subjective symptoms reported. Majority of the adverse effects could be understood as either effects related to intoxication or withdrawal from agonists.

  10. Doxepin (Insomnia)

    Science.gov (United States)

    Doxepin (Silenor) is used to treat insomnia (difficulty falling asleep or staying asleep) in people who have trouble staying asleep. Doxepin (Silenor) is in a class of medications called tricyclic antidepressants. It works by slowing activity in the brain to allow sleep.Doxepin is also available as ...

  11. Patients' motives for participating in active post-marketing surveillance

    NARCIS (Netherlands)

    Harmark, Linda; Lie-Kwie, Miguel; Berm, Lisette; de Gier, Han; van Grootheest, Kees

    Purpose Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased

  12. [Chronic insomnia: not always psychophysiological].

    Science.gov (United States)

    Neerings-Verberkmoes, Nicole E; Vlak, Monique H M; de Lau, Lonneke M L; Hamburger, Hans L

    2014-01-01

    To determine the sensitivity, specificity and the positive and negative predictive value of taking a detailed sleep history for making the diagnosis of psychophysiological insomnia. Retrospective case file study. We examined 767 patients referred to the Amsterdam Centre for Sleep and Wake Disorders, and who underwent polysomnography for the first time between 1 January and 31 December 2010. We compared the probable diagnosis made following history-taking with the final diagnosis made after polysomnography. In this we differentiated between organic and non-organic insomnia. The sensitivity, specificity, positive and negative predictive values of the sleep history were calculated. In 24.8% of the 303 patients whose histories did not indicate organic insomnia, polysomnography showed there to be an organic cause. Primary causes were obstructive sleep apnoea (13.2%), upper airway resistance syndrome (5.4%), and periodic limb movement disorder (4.0%) or a combination of these. In the histories of 464 patients there were indications that the insomnia had an organic cause and in 325 of them this was confirmed by polysomnography. The sensitivity of detailed history taking to psychophysiological insomnia was 62.1%, the specificity 81.3%, the positive predictive value was 75.2% and the negative predictive value was 70.0%. In patients under the age of 40 with a score on the Epworth sleepiness scale insomnia, organic insomnia could not be demonstrated, with the exception of one parasomnia. History-taking only meant that the organic cause was missed in a substantial percentage of patients with insomnia, in particular in older patients with hypersomnolence and a high BMI.

  13. Design and analysis of post-marketing research.

    Science.gov (United States)

    Zhou, Xiao-Hua Andrew; Yang, Wei

    2013-07-01

    A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

  14. Post marketing surveillance of captopril (for hypertension): a preliminary report.

    OpenAIRE

    Chalmers, D; Dombey, S L; Lawson, D H

    1987-01-01

    1 The methodology and interim results of a post marketing surveillance of captopril, the first orally active angiotensin converting enzyme inhibitor are presented. 2 Utilising viewdata technology, details of hypertensive patients were entered directly into a mainframe computer. This allowed day to day monitoring of events; a facility not available with paper-based methods. 3 The design of the study allowed analysis of results including some details of efficacy, concomitant therapy, any diseas...

  15. Social Media Listening for Routine Post-Marketing Safety Surveillance.

    Science.gov (United States)

    Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

    2016-05-01

    Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

  16. Signal detection in post-marketing surveillance for controlled substances.

    Science.gov (United States)

    Dasgupta, Nabarun; Schnoll, Sidney H

    2009-12-01

    Signal detection for pharmaceutical controlled substances presents unique challenges compared to other pharmacovigilance programs because risks are present in the patient and non-patient populations. Defining signals for controlled substances has been difficult because no specific empirical criteria have been established through regulatory actions or guidances. We start with a review of data sources available for decision making to regulators and industry. In this paper we present a framework for processing signals received during post-marketing surveillance: signal identification, verification and assessment, followed by intervention and evaluation. Signal identification involves processing qualitative and quantitative information in order to generate hypotheses describing concerns with controlled substances. Integration of heterogeneous data sources makes this process difficult and we describe multiple approaches utilized in practice today. Signal verification currently relies heavily on telephone interviews with stakeholders in local communities. Once information on a potential signal has been gathered signal assessment is a higher order process conducted with an eye towards broader societal expectations and the ability to intervene or further study the problem. Intervention and evaluation complete the cycle of signal assessment and triage. This paper is intended as a primer of the current practice of signal assessment in the post-marketing surveillance for controlled substances.

  17. Insomnia and paranoia

    OpenAIRE

    Freeman, Daniel; Pugh, Katherine; Vorontsova, Natasha; Southgate, Laura

    2009-01-01

    Insomnia is a potential cause of anxiety, depression, and anomalies of experience; separate research has shown that anxiety, depression and anomalies of experience are predictors of paranoia. Thus insomnia may contribute to the formation and maintenance of persecutory ideation. The aim was to examine for the first time the association of insomnia symptoms and paranoia in the general population and the extent of insomnia in individuals with persecutory delusions attending psychiatric services....

  18. Japanese Physicians' Views on Drug Post-Marketing Surveillance.

    Science.gov (United States)

    Maeda, Kazuki; Katashima, Rumi; Ishizawa, Keisuke; Yanagawa, Hiroaki

    2015-12-01

    Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians' views on PMS with the aim of conducting PMS more effectively. We retrospectively reviewed records between 2009 and 2013 from the institutional review board of Tokushima University Hospital, an academic hospital in rural Japan. The annual number of times PMS was performed was then determined. Next, we assessed physicians' attitudes toward drug PMS, including ethical issues, in a cross-sectional study using a questionnaire designed for this study. Five- and two-point scales were used. The questionnaire was distributed in 2014 to 221 physicians listed as investigators in PMS contracts. Of the 221 physicians, 103 (46.6%) responded to the questionnaire. About 50% of the respondents had experience writing PMS reports. Many of the physicians considered PMS to be important but burdensome. Furthermore, from the viewpoint of research ethics, many physicians considered it improper within the present PMS framework to collect and provide data beyond the scope of routine clinical practice without obtaining informed consent in the case of extra blood sampling, provision of images, monitoring and controlled studies. Beyond practical factors such as workload, attention should be given to establishing an ethical infrastructure and globally harmonized system with regard to the Japanese PMS system. Given the limitations of this single-institution study, further research is needed to collect information for developing a suitable infrastructure.

  19. [Discussion on the building of post market risk analysis method in hemodialysis device].

    Science.gov (United States)

    Xu, Honglei; Peng, Xiaolong; Tian, Xiaojun; Wang, Peilian

    2014-09-01

    This paper discussed the building of post market risk analysis method in hemodialysis device from the point of government supervision. By proposing practical research methods for post market risk identification and estimation on hemodialysis device, providing technical guidance for government to put risk management of hemodialysis device into effect, and offering reference for enterprises to carry out post market risk evaluation on their products as well.

  20. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  1. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

  2. Familial Aggregation of Insomnia.

    Science.gov (United States)

    Jarrin, Denise C; Morin, Charles M; Rochefort, Amélie; Ivers, Hans; Dauvilliers, Yves A; Savard, Josée; LeBlanc, Mélanie; Merette, Chantal

    2017-02-01

    There is little information about familial aggregation of insomnia; however, this type of information is important to (1) improve our understanding of insomnia risk factors and (2) to design more effective treatment and prevention programs. This study aimed to investigate evidence of familial aggregation of insomnia among first-degree relatives of probands with and without insomnia. Cases (n = 134) and controls (n = 145) enrolled in a larger epidemiological study were solicited to invite their first-degree relatives and spouses to complete a standardized sleep/insomnia survey. In total, 371 first-degree relatives (Mage = 51.9 years, SD = 18.0; 34.3% male) and 138 spouses (Mage = 55.5 years, SD = 12.2; 68.1% male) completed the survey assessing the nature, severity, and frequency of sleep disturbances. The dependent variable was insomnia in first-degree relatives and spouses. Familial aggregation was claimed if the risk of insomnia was significantly higher in the exposed (relatives of cases) compared to the unexposed cohort (relatives of controls). The risk of insomnia was also compared between spouses in the exposed (spouses of cases) and unexposed cohort (spouses of controls). The risk of insomnia in exposed and unexposed biological relatives was 18.6% and 10.4%, respectively, yielding a relative risk (RR) of 1.80 (p = .04) after controlling for age and sex. The risk of insomnia in exposed and unexposed spouses was 9.1% and 4.2%, respectively; however, corresponding RR of 2.13 (p = .28) did not differ significantly. Results demonstrate evidence of strong familial aggregation of insomnia. Additional research is warranted to further clarify and disentangle the relative contribution of genetic and environmental factors in insomnia. © Sleep Research Society 2016. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  3. MANAGEMENT OF INSOMNIA

    OpenAIRE

    Liya Rosdiana Sholehah

    2013-01-01

    Sleep is an essential component of health and well-being. The effects of insomnia, Whether as a primary or secondary symptoms, is a major health concern and should be closely studied and Examined across all age groups. There is growing evidence that the effects of insomnia on Adolescent's functioning is comparable to that of other major psychiatric disorders (eg, mood disorders, anxiety disorders, etc..). Insomnia is associated with significant negative Consequences, impairing functioning acr...

  4. Insomnia and paranoia.

    Science.gov (United States)

    Freeman, Daniel; Pugh, Katherine; Vorontsova, Natasha; Southgate, Laura

    2009-03-01

    Insomnia is a potential cause of anxiety, depression, and anomalies of experience; separate research has shown that anxiety, depression and anomalies of experience are predictors of paranoia. Thus insomnia may contribute to the formation and maintenance of persecutory ideation. The aim was to examine for the first time the association of insomnia symptoms and paranoia in the general population and the extent of insomnia in individuals with persecutory delusions attending psychiatric services. Assessments of insomnia, persecutory ideation, anxiety, and depression were completed by 300 individuals from the general population and 30 individuals with persecutory delusions and a diagnosis of non-affective psychosis. Insomnia symptoms were clearly associated with higher levels of persecutory ideation. Consistent with the theoretical understanding of paranoia, the association was partly explained by the presence of anxiety and depression. Moderate or severe insomnia was present in more than 50% of the delusions group. The study provides the first direct evidence that insomnia is common in individuals with high levels of paranoia. It is plausible that sleep difficulties contribute to the development of persecutory ideation. The intriguing implication is that insomnia interventions for this group could have the added benefit of lessening paranoia.

  5. Patients' motives for participating in active post-marketing surveillance.

    Science.gov (United States)

    Härmark, Linda; Lie-Kwie, Miguel; Berm, Lisette; de Gier, Han; van Grootheest, Kees

    2013-01-01

    Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased insight in this matter can help us to better understand and interpret patient reported information, and it can be used for developing and improving patient-based pharmacovigilance tools. The aim of this study is to gain insight into patients' motives for participating in active PMS and investigate their experiences with such a system. A mixed model approach combining qualitative and quantitative research methods was used. For both parts, patients participating in a web-based intensive monitoring study about the safety of anti-diabetic drugs (excluding insulins) were used. A questionnaire was developed based on the results from qualitative interviews. The data collected through the questionnaires was analysed with descriptive statistics. Relations between patient characteristics and motives were analysed using a t-test or a Chi-squared test. 1332 (54.6%) patients responded to the questionnaire. The main motive for participation was altruism. Often experiencing ADRs or negative experiences with drugs were not important motives. The patient's gender played a role in the different motives for participation. For men, potential future personal benefit from the results was more important than for women. The overall opinion about the system was positive. The knowledge that patients participate in this kind of research from an altruistic point of view may strengthen patient involvement in pharmacovigilance. Copyright © 2012 John Wiley & Sons, Ltd.

  6. Post-marketing drug withdrawals: Pharmacovigilance success, regulatory problems.

    Science.gov (United States)

    Aronson, Jeffrey K

    2017-10-01

    Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence. Conflicts of interest may inhibit decision-making. Recommendations that arise from these observations are that: health professionals and patients should be more vigorously encouraged to report suspected adverse drug reactions; regulatory authorities and drug manufacturers should take quicker confirmatory action when serious suspected adverse drug reactions are reported, even anecdotally, with formal studies to test for causality conducted sooner rather than later, applying lower than usual thresholds for suspicion; temporary suspensions or restrictions could be considered during such assessments; universal guidelines are needed for determining when a drug should be withdrawn if serious adverse drug reactions are suspected; there should be more rigorous monitoring and verification of deaths and reporting of reasons for drop-outs during clinical trials, with more transparency in reporting adverse events and ready access to premarketing clinical study reports; post-marketing drug monitoring systems and medicines regulation in low-to-middle income economies, especially in Africa

  7. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  8. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    Science.gov (United States)

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing

  9. The Pathophysiology of Insomnia

    Science.gov (United States)

    Levenson, Jessica C.; Kay, Daniel B.

    2015-01-01

    Insomnia disorder is characterized by chronic dissatisfaction with sleep quantity or quality that is associated with difficulty falling asleep, frequent nighttime awakenings with difficulty returning to sleep, and/or awakening earlier in the morning than desired. Although progress has been made in our understanding of the nature, etiology, and pathophysiology of insomnia, there is still no universally accepted model. Greater understanding of the pathophysiology of insomnia may provide important information regarding how, and under what conditions, the disorder develops and is maintained as well as potential targets for prevention and treatment. The aims of this report are (1) to summarize current knowledge on the pathophysiology of insomnia and (2) to present a model of the pathophysiology of insomnia that considers evidence from various domains of research. Working within several models of insomnia, evidence for the pathophysiology of the disorder is presented across levels of analysis, from genetic to molecular and cellular mechanisms, neural circuitry, physiologic mechanisms, sleep behavior, and self-report. We discuss the role of hyperarousal as an overarching theme that guides our conceptualization of insomnia. Finally, we propose a model of the pathophysiology of insomnia that integrates the various types of evidence presented. PMID:25846534

  10. Pharmacotherapy of Pediatric Insomnia

    Science.gov (United States)

    Owens, Judith A.

    2009-01-01

    General guidelines for the use of medication to treat pediatric insomnia are presented. It should be noted that medication is not the first treatment choice and should be viewed within the context of a more comprehensive treatment plan. The pharmacological and clinical properties of over the counter medications and FDA-approved insomnia drugs are…

  11. Sleep Disorders: Insomnia.

    Science.gov (United States)

    Burman, Deepa

    2017-09-01

    Insomnia is the most common type of sleep disorder in the family medicine population. It is defined as a persistent difficulty initiating or maintaining sleep, or a report of nonrestorative sleep, accompanied by related daytime impairment. Insomnia is a significant public health problem because of its high prevalence and management challenges. There is increasing evidence of a strong association between insomnia and various medical and psychiatric comorbidities. Diagnosis of insomnia and treatment planning rely on a thorough sleep history to address contributing and precipitating factors as well as maladaptive behaviors resulting in poor sleep. Using a sleep diary or sleep log is more accurate than patient recall to determine sleep patterns. A sleep study is not routinely indicated for evaluation of insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is the mainstay of treatment and is a safe and effective approach. The key challenge of CBT-I is the lack of clinicians to implement it. The newer generation nonbenzodiazepines (eg, zolpidem, zaleplon) are used as first-line pharmacotherapy for chronic insomnia. Newer drugs active on targets other than the gamma-aminobutyric acid receptor are now available, but clear treatment guidelines are needed. Written permission from the American Academy of Family Physicians is required for reproduction of this material in whole or in part in any form or medium.

  12. Insomnia (primary) in older people

    OpenAIRE

    Alessi, Cathy; Vitiello, Michael V

    2011-01-01

    Up to 40% of older adults have insomnia, with difficulty getting to sleep, early waking, or feeling unrefreshed on waking. The prevalence of insomnia increases with age. Other risk factors include medical and psychiatric illnesses, psychological factors, stress, daytime napping, and hyperarousal.Primary insomnia is a chronic and relapsing condition that may increase the risks of accidents.Primary insomnia is chronic insomnia without specific underlying medical, psychiatric, or other sleep ...

  13. Insomnia in Iranian Traditional Medicine

    OpenAIRE

    Feyzabadi, Zohre; Jafari, Farhad; Feizabadi, Parvin Sadat; Ashayeri, Hassan; Esfahani, Mohammad Mahdi; Badiee Aval, Shapour

    2014-01-01

    Context: Insomnia is one of the most prevalent sleep disorders characterized by sleep difficulty that impairs daily functioning and reduces quality of life. The burden of medical, psychiatric, interpersonal, and societal consequences of insomnia expresses the importance of diagnosing and treatment of insomnia. The aim of study was to investigate causes of insomnia from the viewpoint of Iranian traditional medicine. Evidence Acquisition: In this review study, we searched insomnia in a few of t...

  14. [Etiology of adult insomnia].

    Science.gov (United States)

    Dollander, M

    2002-01-01

    In the article, the author develops an analysis of external and intrapsychic factors related to adults' insomnia. First she undertakes a literature review to describe semiological, evolutive and etiological levels of insomnia. From a semiological point of view, it is usual to differenciate initial insomnia (associated to the first phase of sleeping), intermittent insomnia (related to frequent awakenings) and final insomnia (related to early morning awakenings). From an evolutive point of view, we can identify transitory insomnia (characterized by frequent awakenings) and chronic insomnia. On the other hand, we are allowed to distinguish organic insomnia (disorder where an organic cerebral injury is demonstrated or suspected) from insomnias related to psychiatric or somatic disease or idiopathic one. Then, the author makes a literary review to identify various insomnia causes and points out. Social factors: insomnia rates are higher by divorced, separated or widowed people. Percentages are higher when scholastic level is weak, domestic income is less then 915 O a month, or by unemployed people. Besides, sleep quality is deteriorated by ageing. Sleeping and waking rhythm is able to loose its synchronization. Complaints about insomnia occur far frequently from women than men. Environmental factors: working constraints increase sleep disorders. It is possible to make the same conclusion when we have to face overcharge of external events, deep intrapsychic conflicts (related to grief, unemployment, damage or hospitalization) or interpersonal conflicts' situations where we are confronted to stress related to socio-affective environment, lack of social support or conjugal difficulties. Medical and physiologic causes: legs impatience syndrome, recurrent limbs shakings syndrome, breathe stop during sleep, narcolepsy, excessive medicine or hypnotic drugs use, some central nervous system injuries, every nocturnal awakening (related to aches.), surgical operation

  15. Insomnia of childhood.

    Science.gov (United States)

    Lipton, Jonathan; Becker, Ronald E; Kothare, Sanjeev V

    2008-12-01

    Insomnia is a major public health problem and is the most common sleep disturbance in both adults and children. The causes of sleeplessness are age-dependent and have potentially enormous effects on cognitive development, behavior, family dynamics, and the metabolic health of children. Here we review the epidemiology, cause, pathophysiology, and clinical approach to pediatric insomnia. Normal sleep is crucial for brain function, behavior, and normal metabolism. Consistently, sleep loss has been linked to behavioral and attention problems, impaired learning and memory, obesity, and psychiatric disorders. The neurological mechanisms that govern sleep initiation and maintenance are poorly understood. The types of insomnia are age-dependent and can occur as primary disorders, or in the context of another primary sleep disorder such as restless legs syndrome, or secondary to another underlying medical condition. Children with chronic diseases and especially children with neurodevelopmental disorders are at particular risk of insomnia. Pediatric insomnia is common and is a source of potential psychophysiological stress to both children and their caregivers. The causes of insomnia are various. Pediatricians should have a working knowledge of the causes of sleeplessness in order to promptly curtail the chronic effects of sleep loss and effectively screen for underlying, potentially treatable disorders.

  16. MANAGEMENT OF INSOMNIA

    Directory of Open Access Journals (Sweden)

    Liya Rosdiana Sholehah

    2013-04-01

    Full Text Available Sleep is an essential component of health and well-being. The effects of insomnia, Whether as a primary or secondary symptoms, is a major health concern and should be closely studied and Examined across all age groups. There is growing evidence that the effects of insomnia on Adolescent's functioning is comparable to that of other major psychiatric disorders (eg, mood disorders, anxiety disorders, etc... Insomnia is associated with significant negative Consequences, impairing functioning across a number of emotional, social, cognitive, and physical domains (Carskadon, 1999; Johnson, Roth, Schultz, & Breslau, 2006; Roberts, Roberts, & Duong, 2008b; Wolfson & Carskadon, 1998. Based on the academic literature to date, it is hypothesized that insomnia will be Significantly more prevalent   among   Adolescents   of   the   female   sex   and   among   those   reporting psychological and / or physical health concerns. The analyzes conducted included basic descriptive statistics (frequencies / percentages, bivariate analyzes (Chi-square tests, and a multiple logistic regression. The prevalence rate of insomnia in adolescents was 9.5%, with no significant association found between sex and insomnia. The multivariate analysis Showed Significantly insomnia to be associated with the presence of a chronic condition, selected mood disorders (12 months, in adolescents  who  are  experiencing  "quite  a  bit"  to  "extreme"  life  stress,  and  in adolescents who were living in than other households with both parents. Insomnia was not found to be associated Significantly with sex, selected anxiety disorder (12 months, heavy drinking, heavy cannabis use, and in Adolescents who were only experiencing "some life stress".  heavy cannabis  use  and  having  a selected  anxiety Significantly disorder was associated with insomnia. More informed knowledge can be used to create prevention and treatment strategies to address

  17. Post market surveillance in the german medical device sector - current state and future perspectives.

    Science.gov (United States)

    Zippel, Claus; Bohnet-Joschko, Sabine

    2017-08-01

    Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. DIAGNOSIS AND MANAGEMENT CHRONIC INSOMNIA

    Directory of Open Access Journals (Sweden)

    G.A Dian Puspitha Candra

    2013-03-01

    Full Text Available Insomnia is defined as difficulty to start sleeping, maintain it, or low quality sleeping, if the condition persist for more than one month, it is called chronic insomnia. Diagnosis is made through anamnesa and sleep wake diaries, aktigraphy, polisomnography. Pharmachologycally drugs that have been used to treat insomnia are benzodiazepin reseptor agonis, antihistamine, antidepressant. Non pharmacological ways include behavioural intervention for insomnia, give significant result in decreasing sleep latency, reducing awakness duration during the night and improving total sleeping time.

  19. Insomnia and Well-Being

    Science.gov (United States)

    Hamilton, Nancy A.; Gallagher, Matthew W.; Preacher, Kristopher J.; Stevens, Natalie; Nelson, Christy A.; Karlson, Cynthia; McCurdy, Danyale

    2007-01-01

    Most Americans have occasional problems with insomnia. The relationship of insomnia to illness is well known. However, insomnia may also relate to lower levels of well-being. Although there are various definitions of well-being, one of the most clearly articulated and comprehensive models identifies 2 overarching constructs, psychological…

  20. [Post-marketing drug safety-risk management plan(RMP)].

    Science.gov (United States)

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  1. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    Science.gov (United States)

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  2. Insomnia and sleep misperception.

    Science.gov (United States)

    Bastien, C H; Ceklic, T; St-Hilaire, P; Desmarais, F; Pérusse, A D; Lefrançois, J; Pedneault-Drolet, M

    2014-10-01

    Sleep misperception is often observed in insomnia individuals (INS). The extent of misperception varies between different types of INS. The following paper comprised sections which will be aimed at studying the sleep EEG and compares it to subjective reports of sleep in individuals suffering from either psychophysiological insomnia or paradoxical insomnia and good sleeper controls. The EEG can be studied without any intervention (thus using the raw data) via either PSG or fine quantitative EEG analyses (power spectral analysis [PSA]), identifying EEG patterns as in the case of cyclic alternating patterns (CAPs) or by decorticating the EEG while scoring the different transient or phasic events (K-Complexes or sleep spindles). One can also act on the on-going EEG by delivering stimuli so to study their impact on cortical measures as in the case of event-related potential studies (ERPs). From the paucity of studies available using these different techniques, a general conclusion can be reached: sleep misperception is not an easy phenomenon to quantify and its clinical value is not well recognized. Still, while none of the techniques or EEG measures defined in the paper is available and/or recommended to diagnose insomnia, ERPs might be the most indicated technique to study hyperarousal and sleep quality in different types of INS. More research shall also be dedicated to EEG patterns and transient phasic events as these EEG scoring techniques can offer a unique insight of sleep misperception. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  3. European guideline for the diagnosis and treatment of insomnia.

    Science.gov (United States)

    Riemann, Dieter; Baglioni, Chiara; Bassetti, Claudio; Bjorvatn, Bjørn; Dolenc Groselj, Leja; Ellis, Jason G; Espie, Colin A; Garcia-Borreguero, Diego; Gjerstad, Michaela; Gonçalves, Marta; Hertenstein, Elisabeth; Jansson-Fröjmark, Markus; Jennum, Poul J; Leger, Damien; Nissen, Christoph; Parrino, Liborio; Paunio, Tiina; Pevernagie, Dirk; Verbraecken, Johan; Weeß, Hans-Günter; Wichniak, Adam; Zavalko, Irina; Arnardottir, Erna S; Deleanu, Oana-Claudia; Strazisar, Barbara; Zoetmulder, Marielle; Spiegelhalder, Kai

    2017-12-01

    This European guideline for the diagnosis and treatment of insomnia was developed by a task force of the European Sleep Research Society, with the aim of providing clinical recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The target audience for this guideline includes all clinicians involved in the management of insomnia, and the target patient population includes adults with chronic insomnia disorder. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to grade the evidence and guide recommendations. The diagnostic procedure for insomnia, and its co-morbidities, should include a clinical interview consisting of a sleep history (sleep habits, sleep environment, work schedules, circadian factors), the use of sleep questionnaires and sleep diaries, questions about somatic and mental health, a physical examination and additional measures if indicated (i.e. blood tests, electrocardiogram, electroencephalogram; strong recommendation, moderate- to high-quality evidence). Polysomnography can be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders), in treatment-resistant insomnia, for professional at-risk populations and when substantial sleep state misperception is suspected (strong recommendation, high-quality evidence). Cognitive behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (strong recommendation, high-quality evidence). A pharmacological intervention can be offered if cognitive behavioural therapy for insomnia is not sufficiently effective or not available. Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines

  4. Professional correlates of insomnia.

    Science.gov (United States)

    Léger, Damien; Massuel, Marie-Anne; Metlaine, Arnaud

    2006-02-01

    Insomnia is a highly prevalent disorder that affects daytime functioning, behavior, and quality of life. Several reports have shown that insomnia impacts on the workforce and is associated with an increased risk of absenteeism. However, few workplace studies have been performed. Our study attempted to evaluate the professional correlates of insomnia by comparing a group of workers with insomnia to a matched group of good sleepers. The main objective measure was absenteeism. Accidents, self-esteem at work, job satisfaction, and efficiency at work were also investigated. Pairs of workers with insomnia (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition definition) and good sleepers, matched by age, sex, and occupational status, were interviewed by their occupational physician and also answered a self-administered questionnaire on work-related criteria. Objective data on absenteeism (number of days absent from work) were provided by the employers' health resource databases. Paris and the Ile de France region (France). Seven hundred eighty-five subjects completed the questionnaire. We retained 369 pair (ie, 738 subjects) for analysis. Insomniacs missed work twice as often as good sleepers. The difference between insomniacs and good sleepers in terms of absenteeism was particularly high for blue-collar workers (odds ratio = 3.0) and men (odds ratio = 2.31). Insomniacs had also a higher accident rate while driving and, strikingly, a 3-fold greater risk of having 2 or 3 serious road accidents. They also reported poor self-esteem at work, less job satisfaction, and less efficiency at work, compared with good sleepers. Our study found an objective increase in absenteeism in insomniacs compared with good sleepers.

  5. Does comorbid obstructive sleep apnea impair the effectiveness of cognitive and behavioral therapy for insomnia?

    Science.gov (United States)

    Sweetman, Alexander; Lack, Leon; Lambert, Sky; Gradisar, Michael; Harris, Jodie

    2017-11-01

    Comorbid insomnia and obstructive sleep apnea (OSA) represents a highly prevalent and debilitating condition; however, physicians and researchers are still uncertain about the most effective treatment approach. Several research groups have suggested that these patients should initially receive treatment for their insomnia before the sleep apnea is targeted. The current study aims to determine whether Cognitive and Behavioral Therapy for Insomnia (CBT-i) can effectively treat insomnia in patients with comorbid OSA and whether its effectiveness is impaired by the presence of OSA. A retrospective chart review was conducted to examine 455 insomnia patients entering a CBT-i treatment program in a hospital out-patient setting. Three hundred and fourteen patients were diagnosed with insomnia alone and 141 with insomnia and comorbid OSA. Improvements in average sleep diary parameters, global insomnia severity, and several daytime functioning questionnaires from baseline, to post-treatment, to 3-month follow-up were compared between insomnia patients with and without comorbid OSA. Insomnia patients with comorbid OSA experienced significant improvements in insomnia symptoms, global insomnia severity, and other daytime functioning measures during and following treatment. Furthermore, improvements were no different between patients with or without comorbid OSA. Sleep apnea presence and severity were not related to rates of insomnia-remission or treatment-resistance following treatment. CBT-i is an effective treatment in the presence of comorbid OSA. This information offers support for the suggestion that patients with comorbid insomnia and OSA should be treated with CBT-i prior to the treatment of the OSA. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Insomnia in Patients with COPD

    Science.gov (United States)

    Budhiraja, Rohit; Parthasarathy, Sairam; Budhiraja, Pooja; Habib, Michael P.; Wendel, Christopher; Quan, Stuart F.

    2012-01-01

    Study Objectives: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality and may frequently be associated with sleep disturbances. However, the correlates of insomnia in COPD patients have not been well characterized. The aim of the current study was to describe the prevalence of insomnia disorder in COPD and to elucidate the demographic and clinical characteristics of COPD patients that are associated with insomnia. Design: Cross-sectional study. Setting: Clinic-based sample from an academic hospital. Participants: Patients with stable COPD. Measurements: An interviewer-conducted survey was administered to 183 participants with COPD. Seventy-two of these participants (30 with and 42 without insomnia) maintained a sleep diary and underwent actigraphy for 7 days. Results: Insomnia (chronic sleep disturbance associated with impaired daytime functioning) was present in 27.3% of participants. Current tobacco users (odds ratio (OR), 2.13) and those with frequent sadness/anxiety (OR, 3.57) had higher odds, but oxygen use was associated with lower odds (OR, 0.35) of insomnia. Patients with insomnia had worse quality of life and a higher prevalence of daytime sleepiness. Actigraphy revealed shorter sleep duration and lower sleep efficiency, and a sleep diary revealed worse self-reported sleep quality in participants with insomnia. Conclusion: Insomnia disorder is highly prevalent in patients with COPD; current tobacco use and sadness/anxiety are associated with a higher prevalence, and oxygen use with a lower prevalence of insomnia; patients with insomnia have poorer quality of life and increased daytime sleepiness; and insomnia is associated with worse objective sleep quality. Citation: Budhiraja R; Parthasarathy S; Budhiraja P; Habib MP; Wendel C; Quan SF. Insomnia in patients with COPD. SLEEP 2012;35(3):369-375. PMID:22379243

  7. Insomnia in Pregnancy and Factors Related to Insomnia

    OpenAIRE

    Kızılırmak, Aynur; Timur, Sermin; Kartal, Bahtışen

    2012-01-01

    This study aims to investigate insomnia experienced by pregnant women and factors associated with it. This study was designed as hospital-based, descriptive, and cross-sectional research. The participants were 486 people chosen with nonprobability random sampling method. The data were collected through Women’s Health Initiative Insomnia Rating Scale, Beck Depression Inventory, and Interview Form. Insomnia prevalence in women participating in this study was found 52.2%. The results of logistic...

  8. Post-marketing surveillance of anti-malarial medicines used in Malawi.

    Science.gov (United States)

    Chikowe, Ibrahim; Osei-Safo, Dorcas; Harrison, Jerry J E K; Konadu, Daniel Y; Addae-Mensah, Ivan

    2015-03-25

    -malarial medicines so there is an urgent need to carry out regular and thorough post-market surveillance of medicines to ensure better quality health care delivery.

  9. Sleep Education for Paradoxical Insomnia

    OpenAIRE

    Geyer, James D.; Lichstein, Kenneth L.; Ruiter, Megan E.; Ward, L. Charles; Carney, Paul R.; Dillard, Stephenie C.

    2011-01-01

    This case study series investigated a new treatment for paradoxical insomnia patients as there is no standard treatment for this patient group at this time. Four paradoxical insomnia patients had a polysomnography (PSG) sleep study, an unsuccessful brief course of behavioral treatment for insomnia, and then a novel sleep education treatment comprising review of their PSG with video and exploration of the discrepancy between their reported and observed sleep experience. Two patients responded ...

  10. Insomnia in patients with COPD.

    Science.gov (United States)

    Budhiraja, Rohit; Parthasarathy, Sairam; Budhiraja, Pooja; Habib, Michael P; Wendel, Christopher; Quan, Stuart F

    2012-03-01

    Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality and may frequently be associated with sleep disturbances. However, the correlates of insomnia in COPD patients have not been well characterized. The aim of the current study was to describe the prevalence of insomnia disorder in COPD and to elucidate the demographic and clinical characteristics of COPD patients that are associated with insomnia. Cross-sectional study. Clinic-based sample from an academic hospital. Patients with stable COPD. An interviewer-conducted survey was administered to 183 participants with COPD. Seventy-two of these participants (30 with and 42 without insomnia) maintained a sleep diary and underwent actigraphy for 7 days. Insomnia (chronic sleep disturbance associated with impaired daytime functioning) was present in 27.3% of participants. Current tobacco users (odds ratio (OR), 2.13) and those with frequent sadness/anxiety (OR, 3.57) had higher odds, but oxygen use was associated with lower odds (OR, 0.35) of insomnia. Patients with insomnia had worse quality of life and a higher prevalence of daytime sleepiness. Actigraphy revealed shorter sleep duration and lower sleep efficiency, and a sleep diary revealed worse self-reported sleep quality in participants with insomnia. Insomnia disorder is highly prevalent in patients with COPD; current tobacco use and sadness/anxiety are associated with a higher prevalence, and oxygen use with a lower prevalence of insomnia; patients with insomnia have poorer quality of life and increased daytime sleepiness; and insomnia is associated with worse objective sleep quality.

  11. Insomnia: prevalence and associated factors

    OpenAIRE

    Lopes, Cátia; Lopes, Daniela; Ferreira, Sofia; Correia, Teresa; Pinto, Isabel C.

    2014-01-01

    Nowadays sleep disorders are very common and affect most of the population, the most common may be insomnia. Insomnia is defined as the difficulty of initiating or maintaining sleep it, may also be reflected in an early wake up and by the presence of a non-restful sleep and it is associated with impairment in social and occupational functioning of the individual. Knowing the prevalence and the associated factors of insomnia. This is a cross-sectional epidemiological study. The pop...

  12. How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

    Directory of Open Access Journals (Sweden)

    Ran Tian

    2017-10-01

    Full Text Available The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i define the therapeutic aim; ii design the protocol; iii control the quality of proprietary Chinese medicine; iv implement the protocol in the trial; v study the mechanism-of-action of the proprietary Chinese medicine and vi describe the indications of the proprietary Chinese medicine. We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.

  13. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    OpenAIRE

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate po...

  14. How to establish precise proprietary Chinese medicine in post-marketing reappraisal?

    OpenAIRE

    Ran Tian; Liang Dai; Hong-Cai Shang; You-Ping Li; Zhao-Xiang Bian

    2017-01-01

    The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern. The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine. In this paper, we propose a reappraisal protocol called “precise proprietary Chinese medicine” to precisely i) define the therapeutic aim; ii) design the proto...

  15. MANAJEMENT OF INSOMNIA IN GERIATRIC PATIENTS

    OpenAIRE

    Cokorda Istri Devi Larayanthi

    2013-01-01

    Sleep is an unconscious condition that is relatively more responsive to internal stimuli. Insomnia is a sleep disorder with characteristic difficulty of initiating sleep or difficulty in maintaining sleep. Insomnia is divided into 2 primary insomnia and secondary insomnia. Conection with age, the function of organs in the body decreases. So that geriatric patients are susceptible to illnesses, especially insomnia. Many of the causes of insomnia in geriatric mental disorders, psychiatric, gene...

  16. [Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

    Science.gov (United States)

    Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

    2017-08-01

    As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels: optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects: mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

  17. Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data.

    Science.gov (United States)

    Telfair, Tamara; Mohan, Aparna K; Shahani, Shalini; Klincewicz, Stephen; Atsma, Willem Jan; Thomas, Adrian; Fife, Daniel

    2006-10-01

    The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation. Copyright 2006 John Wiley & Sons, Ltd.

  18. Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study.

    Science.gov (United States)

    Yahno, Nikolay N; Fedotova, Anastasia V

    2017-01-01

    In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197), fluvoxamine (50-300 mg/day for 90 days) was effective for the treatment of depression in 299 adult patients (age ≥18 years) with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively), global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale). The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296) was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant ( P 85%) recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200) experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment ( P research merit evaluation in controlled trials.

  19. [Insomnia associated with psychiatric disorders].

    Science.gov (United States)

    Suzuki, Masahiro; Konno, Chisato; Furihata, Ryuji; Osaki, Koichi; Uchiyama, Makoto

    2009-08-01

    Most psychiatric disorders, such as schizophrenia, mood disorders, or neurotic disorders are associated with sleep disorders of various kinds, among which insomnia is most prevalent and important in psychiatric practice. Almost all patients suffering from major depression complain of insomnia. Pharmacological treatment of insomnia associated with major depression shortens the duration to achieve remission of depression. Insomnia has been recently reported to be a risk factor for depression. In patients with schizophrenia, insomnia is often an early indicator of the aggravation of psychotic symptoms. Electroencephalographic sleep studies have also revealed sleep abnormalities characteristic to mood disorders, schizophrenia and anxiety disorders. A shortened REM sleep latency has been regarded as a biological marker of depression. Reduced amount of deep non-REM sleep has been reported to be correlated with negative symptoms of schizophrenia. Recently, REM sleep abnormalities were found in teenagers having post-traumatic stress disorder after a boat accident. Although these facts indicate that insomnia plays an important role in the development of psychiatric disorders, there are few hypotheses explaining the cause and effect of insomnia in these disorders. Here, we reviewed recent articles on insomnia associated with psychiatric disorders together with their clinical managements.

  20. Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

    Science.gov (United States)

    Silva, Ivair R

    2018-01-15

    Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

  1. Insomnia disorder and endogenous neurophysiological dynamics

    NARCIS (Netherlands)

    Colombo, M.

    2018-01-01

    Insomnia symptoms are the most common medical complaints, affecting up to a third of the general population. Insomnia symptoms include sleep problems (initiating or maintaining sleep) as well their repercussions on wake-time functioning. Insomnia Disorder can be diagnosed when insomnia symptoms are

  2. The societal costs of insomnia

    Directory of Open Access Journals (Sweden)

    Alan G Wade

    2010-12-01

    Full Text Available Alan G WadeCPS Research, Glasgow, ScotlandObjective: Insomnia can be broadly defined as difficulty initiating or maintaining sleep, or sleep that is not refreshing or of poor quality with negative effect on daytime function. Insomnia can be a primary condition or comorbid to an underlying disorder. Subjective measures of insomnia used in population studies, usually based on complaints of unsatisfactory sleep, put the prevalence at about 10%. Insomnia is more common in the elderly and in women, and is often associated with medical and psychiatric disorders. This review examines the measures used to assess quality of sleep (QOS and daytime functioning and the impact of insomnia on society using these measures.Methods: Literature searches were performed to identify all studies of insomnia (primary and comorbid in adults (aged 18–64 years and the elderly (aged ≥ 65 years with baseline and/or outcomes relating to QOS or daytime functioning. The impact of poor QOS on quality of life (QOL, psychomotor and cognitive skills, health care resource utilization, and other societal effects was examined.Results: Although definitions and measurement scales used to assess sleep quality vary widely, it is clear that the societal consequences of insomnia are substantial and include impaired QOL and increased health care utilization. The impact of poor QOS and impaired daytime functioning common in insomnia can lead to indirect effects such as lower work productivity, increased sick leave, and a higher rate of motor vehicle crashes.Conclusions: Insomnia is associated with substantial direct and indirect costs to society. It is almost impossible to separate the costs associated with primary and comorbid insomnia. More studies are required which control for the severity of any primary disorder to accurately evaluate the costs of comorbid insomnia. Development of standardized diagnostic and assessment scales will enable more accurate quantification of the true

  3. Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis.

    Science.gov (United States)

    Cohen, Stanley; Curtis, Jeffrey R; DeMasi, Ryan; Chen, Yan; Fan, Haiyun; Soonasra, Arif; Fleischmann, Roy

    2018-02-22

    Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5 mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.

  4. Neuroimaging findings in primary insomnia.

    Science.gov (United States)

    O'Byrne, J N; Berman Rosa, M; Gouin, J-P; Dang-Vu, T T

    2014-10-01

    State-of-the-art neuroimaging techniques have accelerated progress in the study and understanding of sleep in humans. Neuroimaging studies in primary insomnia remain relatively few, considering the important prevalence of this disorder in the general population. This review examines the contribution of functional and structural neuroimaging to our current understanding of primary insomnia. Functional studies during sleep provided support for the hyperarousal theory of insomnia. Functional neuroimaging also revealed abnormalities in cognitive and emotional processing in primary insomnia. Results from structural studies suggest neuroanatomical alterations in primary insomnia, mostly in the hippocampus, anterior cingulate cortex and orbitofrontal cortex. However, these results are not well replicated across studies. A few magnetic resonance spectroscopy studies revealed abnormalities in neurotransmitter concentrations and bioenergetics in primary insomnia. The inconsistencies among neuroimaging findings on insomnia are likely due to clinical heterogeneity, differences in imaging and overall diversity of techniques and designs employed. Larger samples, replication, as well as innovative methodologies are necessary for the progression of this perplexing, yet promising area of research. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  5. Behavioral interventions for insomnia: Theory and practice

    OpenAIRE

    Sharma, Mahendra P.; Andrade, Chittaranjan

    2012-01-01

    Insomnia is a general clinical term that refers to a difficulty in initiating or maintaining sleep. Insomnia is widely prevalent in the general population, especially in the elderly and in those with medical and psychiatric disorders. Hypnotic drug treatments of insomnia are effective but are associated with potential disadvantages. This article presents an overview of behavioral interventions for insomnia. Behavioral interventions for insomnia include relaxation training, stimulus control th...

  6. Pediatric post-marketing safety systems in North America: assessment of the current status.

    Science.gov (United States)

    McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne

    2015-08-01

    It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.

  7. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    Science.gov (United States)

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  8. Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance.

    Science.gov (United States)

    Silva, I R; Kulldorff, M

    2015-09-01

    The use of sequential statistical analysis for post-market drug safety surveillance is quickly emerging. Both continuous and group sequential analysis have been used, but consensus is lacking as to when to use which approach. We compare the statistical performance of continuous and group sequential analysis in terms of type I error probability; statistical power; expected time to signal when the null hypothesis is rejected; and the sample size required to end surveillance without rejecting the null. We present a mathematical proposition to show that for any group sequential design there always exists a continuous sequential design that is uniformly better. As a consequence, it is shown that more frequent testing is always better. Additionally, for a Poisson based probability model and a flat rejection boundary in terms of the log likelihood ratio, we compare the performance of various continuous and group sequential designs. Using exact calculations, we found that, for the parameter settings used, there is always a continuous design with shorter expected time to signal than the best group design. The two key conclusions from this article are (i) that any post-market safety surveillance system should attempt to obtain data as frequently as possible, and (ii) that sequential testing should always be performed when new data arrives without deliberately waiting for additional data. © 2015, The International Biometric Society.

  9. Herpes zoster vaccine live: A 10 year review of post-marketing safety experience.

    Science.gov (United States)

    Willis, English D; Woodward, Meredith; Brown, Elizabeth; Popmihajlov, Zoran; Saddier, Patricia; Annunziato, Paula W; Halsey, Neal A; Gershon, Anne A

    2017-12-19

    Zoster vaccine is a single dose live, attenuated vaccine (ZVL) indicated for individuals ≥50 years-old for the prevention of herpes zoster (HZ). Safety data from clinical trials and post-licensure studies provided reassurance that ZVL is generally safe and well tolerated. The objective of this review was to provide worldwide post-marketing safety information following 10 years of use and >34 million doses distributed. All post-marketing adverse experience (AE) reports received worldwide between 02-May-2006 and 01-May-2016 from healthcare professionals following vaccination with ZVL and submitted to the MSD AE global safety database, were analyzed. A total of 23,556 AE reports, 93% non-serious, were reported. Local injection site reactions (ISRs), with a median time-to-onset of 2 days, were the most frequently reported AEs followed by HZ. The majority of HZ reports were reported within 2 weeks of vaccination and considered, based on time-to-onset, pathogenesis of HZ, and data from clinical trials, to be caused by wild-type varicella-zoster virus (VZV). HZ confirmed by PCR analysis to be VZV Oka/Merck vaccine-strain was identified in an immunocompetent individual 8 months postvaccination and in 4 immunocompromised individuals. Disseminated HZ was reported very rarely (marketing use, was favorable and consistent with that observed in clinical trials and post-licensure studies. Copyright © 2017 Elsevier Ltd. All rights reserved.

  10. Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

    Science.gov (United States)

    Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

    2018-01-01

    Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

  11. Nonpharmacologic Management of Chronic Insomnia.

    Science.gov (United States)

    Maness, David L; Khan, Muneeza

    2015-12-15

    Insomnia affects 10% to 30% of the population with a total cost of $92.5 to $107.5 billion annually. Short-term, chronic, and other types of insomnia are the three major categories according to the International Classification of Sleep Disorders, 3rd ed. The criteria for diagnosis are difficulty falling asleep, difficulty staying asleep, or early awakening despite the opportunity for sleep; symptoms must be associated with impaired daytime functioning and occur at least three times per week for at least one month. Factors associated with the onset of insomnia include a personal or family history of insomnia, easy arousability, poor self-reported health, and chronic pain. Insomnia is more common in women, especially following menopause and during late pregnancy, and in older adults. A comprehensive sleep history can confirm the diagnosis. Psychiatric and medical problems, medication use, and substance abuse should be ruled out as contributing factors. Treatment of comorbid conditions alone may not resolve insomnia. Patients with movement disorders (e.g., restless legs syndrome, periodic limb movement disorder), circadian rhythm disorders, or breathing disorders (e.g., obstructive sleep apnea) must be identified and treated appropriately. Chronic insomnia is associated with cognitive difficulties, anxiety and depression, poor work performance, decreased quality of life, and increased risk of cardiovascular disease and all-cause mortality. Insomnia can be treated with nonpharmacologic and pharmacologic therapies. Nonpharmacologic therapies include sleep hygiene, cognitive behavior therapy, relaxation therapy, multicomponent therapy, and paradoxical intention. Referral to a sleep specialist may be considered for refractory cases.

  12. Sensory gating in primary insomnia.

    Science.gov (United States)

    Hairston, Ilana S; Talbot, Lisa S; Eidelman, Polina; Gruber, June; Harvey, Allison G

    2010-06-01

    Although previous research indicates that sleep architecture is largely intact in primary insomnia (PI), the spectral content of the sleeping electroencephalographic trace and measures of brain metabolism suggest that individuals with PI are physiologically more aroused than good sleepers. Such observations imply that individuals with PI may not experience the full deactivation of sensory and cognitive processing, resulting in reduced filtering of external sensory information during sleep. To test this hypothesis, gating of sensory information during sleep was tested in participants with primary insomnia (n = 18) and good sleepers (n = 20). Sensory gating was operationally defined as (i) the difference in magnitude of evoked response potentials elicited by pairs of clicks presented during Wake and Stage II sleep, and (ii) the number of K complexes evoked by the same auditory stimulus. During wake the groups did not differ in magnitude of sensory gating. During sleep, sensory gating of the N350 component was attenuated and completely diminished in participants with insomnia. P450, which occurred only during sleep, was strongly gated in good sleepers, and less so in participants with insomnia. Additionally, participants with insomnia showed no stimulus-related increase in K complexes. Thus, PI is potentially associated with impaired capacity to filter out external sensory information, especially during sleep. The potential of using stimulus-evoked K complexes as a biomarker for primary insomnia is discussed.

  13. Statement on the post-marketing monitoring of the use of lycopene

    DEFF Research Database (Denmark)

    Tetens, Inge

    2015-01-01

    information from the post-marketing monitoring programme imposed by the Commission Decisions authorising the use of synthetic lycopene, lycopene oleoresin from tomatoes and lycopene from Blakeslea trispora as a novel food ingredient in several foodstuffs. The marketing authorisation holders for the use...... of lycopene as a novel food ingredient jointly prepared and submitted a dossier containing sales data, product launch data, an intake estimate and toxicological information. On the basis of information on sales and new product launch data for the period from July 2009 to June 2012 provided by the lycopene...... performed by EFSA and data on sales and product launch data provided for the period from July 2009 to June 2012, the Panel concludes that intakes of naturally occurring lycopene and from its use as a food colouring and as a novel food ingredient at permitted use levels do not lead to intakes above the ADI...

  14. Use of carabids for the post-market environmental monitoring of genetically modified crops

    Czech Academy of Sciences Publication Activity Database

    Skoková Habuštová, Oxana; Svobodová, Zdeňka; Cagáň, Ľ.; Sehnal, František

    2017-01-01

    Roč. 9, č. 4 (2017), č. článku 121. E-ISSN 2072-6651 R&D Projects: GA MŠk(CZ) 7AMB14SK096 Grant - others:projekt VEGA(SK) 1/0732/14; GA ČR(CZ) L200961652 Institutional support: RVO:60077344 Keywords : Carabidae * surrogate * post-market environmental monitoring Subject RIV: GF - Plant Pathology, Vermin, Weed, Plant Protection OBOR OECD: GM technology (crops and livestock), livestock cloning, marker assisted selection, diagnostics (DNA chips and biosensing devices for the early/accurate detection of diseases) biomass feedstock production technologies, biopharming Impact factor: 3.030, year: 2016 http://www.mdpi.com/2072-6651/9/4/121

  15. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

  16. [The importance of defining methodology for post-marketing observational studies on cardiovascular therapies].

    Science.gov (United States)

    Pelliccia, Francesco; Barillà, Francesco; Tanzilli, Gaetano; Viceconte, Nicola; Paravati, Vincenzo; Mangieri, Enrico; Gaudio, Carlo

    2017-01-01

    In recent years, a growing number of observational studies in cardiology have been carried out following the criticism that rigid design of randomized clinical trials produces information that is not applicable to the general patient. This approach is very common in several branches of medicine, first of all oncology, but has often been considered marginal in cardiology. The recent introduction of new oral anticoagulants (NOACs) on the market, however, has seen a proliferation of "real-life" studies, drawing the attention of cardiologists to the advantages and limitations of post-marketing studies. NOACs have been approved for use on the basis of large randomized clinical trials that have clearly documented their efficacy and safety. Since they have become available, the analysis of phase IV data has been considered crucial and therefore a great amount of information on the use of NOACs in daily practice has become available. It should be considered, however, that the possibility exists that results obtained from "real-world" studies, which do not apply rigid scientific criteria, may lead to incorrect conclusions. Accordingly, it is mandatory to fully define the operational standards of observational studies. All the protagonists of post-marketing analysis (physicians, epidemiologists, pharmacologists, statisticians) should handle the data strictly in order to ensure their reliability and comparability with other studies. To this end, it is crucial that researchers follow rigorous operational protocols for phase IV studies. Briefly, any "real-life" study should be prospective and adhere to what is prespecified by the research protocol - which must illustrate the background and rationale of the study, define its primary endpoint, and detail the methods, i.e. study design, population and variables.

  17. National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

    Science.gov (United States)

    Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

    2017-05-22

    Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

  18. Post-marketing observational program of the effectiveness of fluvoxamine for the treatment of depression in patients with neurological disorders: the FRIENDS study

    Directory of Open Access Journals (Sweden)

    Yahno NN

    2017-11-01

    Full Text Available Nikolay N Yahno,1 Anastasia V Fedotova2 1Neurology Department, I.M. Sechenov First Moscow State Medical University, 2Neurology Department, Additional Professional Education Faculty, Pirogov Russian National Research Medical University, Moscow, Russian Federation Abstract: In a prospective, non-blinded, uncontrolled, multicenter, post-marketing, observational study (FRIENDS; NCT02043197, fluvoxamine (50–300 mg/day for 90 days was effective for the treatment of depression in 299 adult patients (age ≥18 years with neurological disorders at baseline. The therapeutic effect of fluvoxamine was measured by means of changes in the Hospital Anxiety and Depression Scale depression and anxiety scores (HADS-D and HADS-A, respectively, global severity of illness, and clinical condition (measured using the Clinical Global Improvement [CGI] scale. The mean HADS-D subscale score at baseline in the per-protocol cohort (n=296 was 11.7±3.1 points and the corresponding mean HADS-A score was 12.6±3.2. Significant (P<0.0001 improvements in both scores were recorded during fluvoxamine treatment and later follow-up. Most patients (>85% recorded reductions versus baseline in both indices. In the CGI-based assessment, most evaluated patients (>200 experienced moderate to very substantial clinical improvement, with no or limited side effects. Significant improvements were also recorded in the exploratory outcomes of sleep quality, assessed using the Insomnia Severity Index, and cognitive function, assessed using the Montreal Cognitive Assessment (P<0.0001 vs baseline for both. No death or serious adverse drug reactions were reported during the study. The results of this observational study affirm that fluvoxamine is effective and well tolerated for the treatment of depression in the context of neurological disorders. The effects on the exploratory endpoints of this research merit evaluation in controlled trials. Keywords: depression, anxiety, fluvoxamine

  19. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    Science.gov (United States)

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

  20. Eszopiclone Treatment for Insomnia: Effect Size Comparisons in Patients With Primary Insomnia and Insomnia With Medical and Psychiatric Comorbidity

    OpenAIRE

    Krystal, Andrew D.; McCall, W. Vaughn; Fava, Maurizio; Joffe, Hadine; Soares, Claudio N.; Huang, Holly; Grinell, Todd; Zummo, Jacqueline; Spalding, William; Marshall, Randall

    2012-01-01

    Objective: The purpose of this post hoc analysis was to compare the treatment effect size of eszopiclone 3 mg for insomnia in patients with a diagnosis of primary insomnia and in several of the psychiatric and medical conditions that are most commonly comorbid with insomnia.

  1. Assessing insomnia in adolescents: comparison of Insomnia Severity Index, Athens Insomnia Scale and Sleep Quality Index.

    Science.gov (United States)

    Chung, Ka-Fai; Kan, Katherine Ka-Ki; Yeung, Wing-Fai

    2011-05-01

    To compare the psychometric properties of the Chinese versions of Insomnia Severity Index (ISI), Athens Insomnia Scale (AIS) and Sleep Quality Index (SQI) for assessment and screening of insomnia in adolescents. This is a school-based survey of 1516 adolescents aged 12-19 years. Sleep-wake habit questionnaire, ISI, AIS, SQI, Epworth Sleepiness Scale (ESS) and 12-item General Health Questionnaire (GHQ-12) were administered. Insomnia Interview Schedule was used to assess the severity of insomnia symptoms and DSM-IV-TR diagnosis of insomnia. The Cronbach's alpha of ISI, AIS and SQI were 0.83, 0.81 and 0.65, respectively, and the 2-week test-retest reliability were 0.79, 0.80 and 0.72. All three scales had a 2-factor structure, and their scores were significantly correlated with sleep-wake variables, ESS and GHQ-12 scores, smoking and drinking habits, and academic performance. The areas under curve of ISI, AIS and SQI for detecting clinical insomnia were 0.85, 0.80 and 0.85, respectively. The optimal cut-offs for ISI, AIS and SQI were a total score of nine (sensitivity/specificity: 0.87/0.75), seven (sensitivity/specificity: 0.78/0.74) and five (sensitivity/specificity: 0.83/0.79), respectively. The Chinese versions of ISI, AIS and SQI are reliable and valid instruments. The ISI and AIS appear to have better psychometric properties than the SQI. Copyright © 2011 Elsevier B.V. All rights reserved.

  2. Optimizing Sleep in Older Adults: Treating Insomnia

    OpenAIRE

    Wennberg, Alexandra M.; Canham, Sarah L.; Smith, Michael T.; Spira, Adam P.

    2013-01-01

    As the world’s population ages, the elevated prevalence of insomnia in older adults is a growing concern. Insomnia is characterized by difficulty falling or remaining asleep, or by non-restorative sleep, and resultant daytime dysfunction. In addition to being at elevated risk for primary insomnia, older adults are at greater risk for comorbid insomnia, which results from, or occurs in conjunction with another medical or psychiatric condition. In this review, we discuss normal changes in sleep...

  3. Insomnia and Personality-A Network Approach

    NARCIS (Netherlands)

    Dekker, Kim; Blanken, Tessa F; Van Someren, Eus J W

    2017-01-01

    Studies on personality traits and insomnia have remained inconclusive about which traits show the most direct associations with insomnia severity. It has moreover hardly been explored how traits relate to specific characteristics of insomnia. We here used network analysis in a large sample (N =

  4. Insomnia and Personality-A Network Approach

    NARCIS (Netherlands)

    Dekker, Kim; Blanken, Tessa F; Van Someren, Eus J W

    2017-01-01

    Studies on personality traits and insomnia have remained inconclusive about which traits show the most direct associations with insomnia severity. It has moreover hardly been explored how traits relate to specific characteristics of insomnia. We here used network analysis in a large sample (N= 2089)

  5. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    Science.gov (United States)

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  6. A virtual sleepcoach for people suffering from insomnia

    OpenAIRE

    Horsch, C.H.G.

    2016-01-01

    People suffering from insomnia have problems falling asleep or staying asleep. Insomnia impairs people’s daily life and their quality of life decreases. Approximately 10% of the population suffers from insomnia. The common treatment for insomnia is cognitive behavioural therapy for insomnia (CBT-I), mostly delivered by a therapist that people see once a week. A disadvantage of the current practice of insomnia treatment is the limited accessibility of insomnia treatment. Moreover, adherence to...

  7. Behavioral interventions for insomnia: Theory and practice.

    Science.gov (United States)

    Sharma, Mahendra P; Andrade, Chittaranjan

    2012-10-01

    Insomnia is a general clinical term that refers to a difficulty in initiating or maintaining sleep. Insomnia is widely prevalent in the general population, especially in the elderly and in those with medical and psychiatric disorders. Hypnotic drug treatments of insomnia are effective but are associated with potential disadvantages. This article presents an overview of behavioral interventions for insomnia. Behavioral interventions for insomnia include relaxation training, stimulus control therapy, sleep restriction therapy, sleep hygiene, paradoxical intention therapy, cognitive restructuring, and other approaches. These are briefly explained. Research indicates that behavioral interventions are efficacious, effective, and likely cost-effective treatments for insomnia that yield reliable, robust, and long-term benefits in adults of all ages. Detailed guidance is provided for the practical management of patients with insomnia.

  8. MANAJEMENT OF INSOMNIA IN GERIATRIC PATIENTS

    Directory of Open Access Journals (Sweden)

    Cokorda Istri Devi Larayanthi

    2013-04-01

    Full Text Available Sleep is an unconscious condition that is relatively more responsive to internal stimuli. Insomnia is a sleep disorder with characteristic difficulty of initiating sleep or difficulty in maintaining sleep. Insomnia is divided into 2 primary insomnia and secondary insomnia. Conection with age, the function of organs in the body decreases. So that geriatric patients are susceptible to illnesses, especially insomnia. Many of the causes of insomnia in geriatric mental disorders, psychiatric, general medical conditions, medications, certain substances, and others. Management of insomnia in geriatric patients were divided into 3 method: 1 manage underlying cause, 2 nonpharmacological therapies such as cognitive behavior therapy (CBT, and 3 pharmacological therapies such as benzodiazepine and non-benzodiazepine that eszopiclone and Ramelteon. Pharmacological treatment in geriatrics should follow the rule "start low, go slow", starting dose of ½ of the adult dose, and its use in the short term.

  9. Use of Carabids for the Post-Market Environmental Monitoring of Genetically Modified Crops

    Directory of Open Access Journals (Sweden)

    Oxana Skoková Habuštová

    2017-03-01

    Full Text Available Post-market environmental monitoring (PMEM of genetically modified (GM crops is required by EU legislation and has been a subject of debate for many years; however, no consensus on the methodology to be used has been reached. We explored the suitability of carabid beetles as surrogates for the detection of unintended effects of GM crops in general PMEM surveillance. Our study combines data on carabid communities from five maize field trials in Central Europe. Altogether, 86 species and 58,304 individuals were collected. Modeling based on the gradual elimination of the least abundant species, or of the fewest categories of functional traits, showed that a trait-based analysis of the most common species may be suitable for PMEM. Species represented by fewer than 230 individuals (all localities combined should be excluded and species with an abundance higher than 600 should be preserved for statistical analyses. Sixteen species, representing 15 categories of functional traits fulfill these criteria, are typical dominant inhabitants of agroecocoenoses in Central Europe, are easy to determine, and their functional classification is well known. The effect of sampling year is negligible when at least four samples are collected during maize development beginning from 1 April. The recommended methodology fulfills PMEM requirements, including applicability to large-scale use. However, suggested thresholds of carabid comparability should be verified before definitive conclusions are drawn.

  10. [The role of drug registries in the post-marketing surveillance].

    Science.gov (United States)

    Traversa, Giuseppe; Sagliocca, Luciano; Magrini, Nicola; Venegoni, Mauro

    2013-06-01

    The aim of this article is to provide an introduction to issue of Recenti Progressi in Medicina, devoted to the role of drug registries in the post-marketing surveillance. We first motivate the need to implement registries as a tool in promoting the appropriateness of drug use and acquiring additional information on the risk-benefit profile of drugs. Then, the different role that can be played by registries in comparison with prescription monitoring systems and observational studies is clarified. The presentation of some of the most relevant registries established in Italy since the end of the '90s, with the analysis of their strengths and weaknesses, helps to understand some of the crucial issues that should be taken into account before a new registry is adopted. Specifically, we deal with the relationship between objectives - of appropriateness, effectiveness and safety - and methods; the overlapping between drug-based registries and disease-based ones; the duration and extension of data collection, which may be either exhaustive or based on a sampling frame; the importance of ensuring the quality of the data and to minimize the number of subjects who are lost to follow-up; the importance of infrastructures, and of ad hoc funding, for the functioning of a registry; the independence in data analysis and publication of findings.

  11. Effectiveness and tolerability of parenteral testosterone undecanoate: a post-marketing surveillance study.

    Science.gov (United States)

    Wolf, Jan; Keipert, Dieter; Motazedi, Heiko; Ernst, Michael; Nettleship, Joanne; Gooren, Louis

    2017-12-01

    This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included. Effectiveness and tolerability of TU administration were assessed on a 4-point scale. Body weight, waist girth, blood pressure, hemoglobin levels, hematocrit, prostate-specific antigen (PSA), and digital rectal prostate examination were assessed. Over 90% of subjects completed the observational duration of 52.8 ± 9.7 weeks (mean ± SD) and 56% judged effectiveness as very good, 30.8% as good. 63.1% judged tolerability as very good, and 24.4% as good. No adverse effects on indicators of cardiovascular risk were observed. Polycythemia occurred in one subject and a supranormal hematocrit in one subject. Four subjects developed supranormal PSA levels. Prostate carcinoma was found in one subject, one subject had recurrence of a previously surgically treated prostate carcinoma, and the other two showed no indication of malignancy. Parenteral TU is safe, effective, and well-tolerated in clinical practice proving a good therapeutic option for hypogonadism.

  12. Subjective-objective sleep discrepancy among older adults: associations with insomnia diagnosis and insomnia treatment.

    Science.gov (United States)

    Kay, Daniel B; Buysse, Daniel J; Germain, Anne; Hall, Martica; Monk, Timothy H

    2015-02-01

    Discrepancy between subjective and objective measures of sleep is associated with insomnia and increasing age. Cognitive behavioural therapy for insomnia improves sleep quality and decreases subjective-objective sleep discrepancy. This study describes differences between older adults with insomnia and controls in sleep discrepancy, and tests the hypothesis that reduced sleep discrepancy following cognitive behavioural therapy for insomnia correlates with the magnitude of symptom improvement reported by older adults with insomnia. Participants were 63 adults >60 years of age with insomnia, and 51 controls. At baseline, participants completed sleep diaries for 7 days while wearing wrist actigraphs. After receiving cognitive behavioural therapy for insomnia, insomnia patients repeated this sleep assessment. Sleep discrepancy variables were calculated by subtracting actigraphic sleep onset latency and wake after sleep onset from respective self-reported estimates, pre- and post-treatment. Mean level and night-to-night variability in sleep discrepancy were investigated. Baseline sleep discrepancies were compared between groups. Pre-post-treatment changes in Insomnia Severity Index score and sleep discrepancy variables were investigated within older adults with insomnia. Sleep discrepancy was significantly greater and more variable across nights in older adults with insomnia than controls, P ≤ 0.001 for all. Treatment with cognitive behavioural therapy for insomnia was associated with significant reduction in the Insomnia Severity Index score that correlated with changes in mean level and night-to-night variability in wake after sleep onset discrepancy, P treatments for late-life insomnia. © 2014 European Sleep Research Society.

  13. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  14. Assessment and treatment of insomnia in adult patients with alcohol use disorders.

    Science.gov (United States)

    Brower, Kirk J

    2015-06-01

    Insomnia in patients with alcohol dependence has increasingly become a target of treatment due to its prevalence, persistence, and associations with relapse and suicidal thoughts, as well as randomized controlled studies demonstrating efficacy with behavior therapies and non-addictive medications. This article focuses on assessing and treating insomnia that persists despite 4 or more weeks of sobriety in alcohol-dependent adults. Selecting among the various options for treatment follows a comprehensive assessment of insomnia and its multifactorial causes. In addition to chronic, heavy alcohol consumption and its effects on sleep regulatory systems, contributing factors include premorbid insomnia; co-occurring medical, psychiatric, and other sleep disorders; use of other substances and medications; stress; environmental factors; and inadequate sleep hygiene. The assessment makes use of history, rating scales, and sleep diaries as well as physical, mental status, and laboratory examinations to rule out these factors. Polysomnography is indicated when another sleep disorder is suspected, such as sleep apnea or periodic limb movement disorder, or when insomnia is resistant to treatment. Sobriety remains a necessary, first-line treatment for insomnia, and most patients will have some improvement. If insomnia-specific treatment is needed, then brief behavioral therapies are the treatment of choice, because they have shown long-lasting benefit without worsening of drinking outcomes. Medications work faster, but they generally work only as long as they are taken. Melatonin agonists; sedating antidepressants, anticonvulsants, and antipsychotics; and benzodiazepine receptor agonists each have their benefits and risks, which must be weighed and monitored to optimize outcomes. Some relapse prevention medications may also have sleep-promoting activity. Although it is assumed that treatment for insomnia will help prevent relapse, this has not been firmly established. Therefore

  15. A virtual sleepcoach for people suffering from insomnia

    NARCIS (Netherlands)

    Horsch, C.H.G.

    2016-01-01

    People suffering from insomnia have problems falling asleep or staying asleep. Insomnia impairs people’s daily life and their quality of life decreases. Approximately 10% of the population suffers from insomnia. The common treatment for insomnia is cognitive behavioural therapy for insomnia (CBT-I),

  16. Persistent insomnia is associated with mortality risk.

    Science.gov (United States)

    Parthasarathy, Sairam; Vasquez, Monica M; Halonen, Marilyn; Bootzin, Richard; Quan, Stuart F; Martinez, Fernando D; Guerra, Stefano

    2015-03-01

    Insomnia has been associated with mortality risk, but whether this association is different in subjects with persistent vs intermittent insomnia is unclear. Additionally, the role of systemic inflammation in such an association is unknown. We used data from a community-based cohort to determine whether persistent or intermittent insomnia, defined based on persistence of symptoms over a 6-year period, was associated with death during the following 20 years of follow-up. We also determined whether changes in serum C-reactive protein (CRP) levels measured over 2 decades between study initiation and insomnia determination were different for the persistent, intermittent, and never insomnia groups. The results were adjusted for confounders such as age, sex, body mass index, smoking, physical activity, alcohol, and sedatives. Of the 1409 adult participants, 249 (18%) had intermittent and 128 (9%) had persistent insomnia. During a 20-year follow-up period, 318 participants died (118 due to cardiopulmonary disease). In adjusted Cox proportional-hazards models, participants with persistent insomnia (adjusted hazards ratio [HR] 1.58; 95% confidence interval [CI], 1.02-2.45) but not intermittent insomnia (HR 1.22; 95% CI, 0.86-1.74) were more likely to die than participants without insomnia. Serum CRP levels were higher and increased at a steeper rate in subjects with persistent insomnia as compared with intermittent (P = .04) or never (P = .004) insomnia. Although CRP levels were themselves associated with increased mortality (adjusted HR 1.36; 95% CI, 1.01-1.82; P = .04), adjustment for CRP levels did not notably change the association between persistent insomnia and mortality. In a population-based cohort, persistent, and not intermittent, insomnia was associated with increased risk for all-cause and cardiopulmonary mortality and was associated with a steeper increase in inflammation. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. Environmental change challenges decision-making during post-market environmental monitoring of transgenic crops.

    Science.gov (United States)

    Sanvido, Olivier; Romeis, Jörg; Bigler, Franz

    2011-12-01

    The ability to decide what kind of environmental changes observed during post-market environmental monitoring of genetically modified (GM) crops represent environmental harm is an essential part of most legal frameworks regulating the commercial release of GM crops into the environment. Among others, such decisions are necessary to initiate remedial measures or to sustain claims of redress linked to environmental liability. Given that consensus on criteria to evaluate 'environmental harm' has not yet been found, there are a number of challenges for risk managers when interpreting GM crop monitoring data for environmental decision-making. In the present paper, we argue that the challenges in decision-making have four main causes. The first three causes relate to scientific data collection and analysis, which have methodological limits. The forth cause concerns scientific data evaluation, which is controversial among the different stakeholders involved in the debate on potential impacts of GM crops on the environment. This results in controversy how the effects of GM crops should be valued and what constitutes environmental harm. This controversy may influence decision-making about triggering corrective actions by regulators. We analyse all four challenges and propose potential strategies for addressing them. We conclude that environmental monitoring has its limits in reducing uncertainties remaining from the environmental risk assessment prior to market approval. We argue that remaining uncertainties related to adverse environmental effects of GM crops would probably be assessed in a more efficient and rigorous way during pre-market risk assessment. Risk managers should acknowledge the limits of environmental monitoring programmes as a tool for decision-making.

  18. Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China.

    Science.gov (United States)

    Xie, Yan-Ming; Tian, Feng

    2013-07-01

    This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China's actual conditions, and cooperating with multidisciplinary researchers.

  19. [Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

    Science.gov (United States)

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

    The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

  20. Chronic insomnia cases detection with the help of Athens Insomnia Scale and SF-36 health survey

    Science.gov (United States)

    Wasiewicz, P.; Skalski, M.; Fornal-Pawlowska, Malgorzata

    2011-10-01

    Standardization of the diagnostic process of insomnia is a highly important task in clinical practice, epidemiological considerations and treatment outcomes assessment. In this paper we describe standard surveys relationships within cluster groups with the same insomnia degrees.

  1. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    Energy Technology Data Exchange (ETDEWEB)

    Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

    2015-11-15

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  2. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  3. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    Science.gov (United States)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  4. Post-marketing access to orphan drugs: a critical analysis of health technology assessment and reimbursement decision-making considerations

    OpenAIRE

    Iskrov, Georgi; Stefanov,Rumen

    2014-01-01

    Georgi Iskrov, Rumen Stefanov Department of Social Medicine and Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria Abstract: This study aims to explore the current rationale of post-marketing access to orphan drugs. As access to orphan medicinal products depends on assessment and appraisal by health authorities, this article is focused on health technology assessment (HTA) and reimbursement decision-making considerations for orphan drugs. A critical analysis may identify importa...

  5. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

    International Nuclear Information System (INIS)

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

    2015-01-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

  6. Subjective-objective sleep discrepancy among older adults: Associations with insomnia diagnosis and insomnia treatment

    OpenAIRE

    Kay, Daniel B.; Buysse, Daniel J.; Germain, Anne; Hall, Martica; Monk, Timothy H.

    2014-01-01

    Discrepancy between subjective and objective measures of sleep is associated with insomnia and increasing age. Cognitive behavioral therapy for insomnia improves sleep quality and decreases subjective-objective sleep discrepancy. This study describes differences between older adults with insomnia and controls in sleep discrepancy, and tests the hypothesis that reduced sleep discrepancy following cognitive behavioral therapy for insomnia correlates with the magnitude of symptom improvement rep...

  7. The flawed basis for FDA post-marketing safety decisions: the example of anti-depressants and children.

    Science.gov (United States)

    Klein, Donald F

    2006-04-01

    The FDA (February 3, 2005) issued a black box warning that all antidepressants increase the risk of suicidal thinking and behavior in children and adolescents that must be cited in all advertising as well as included in the package insert. Following this, there was a sharp decrease in antidepressant prescriptions for children with uncertain public health impact. The current black box does not claim that these medications increase the risk of completed suicides, although this is the clear implication of the term 'suicidality'. The interpretation by the press is unequivocal that lethal outcomes prompted this action. This review concludes the following: (1) Since no suicide occurred in clinical trials of approximately 4400 children, the analyses relied upon 'suicidality' as a surrogate. (2) The classification of adverse events by the Columbia group necessarily relied on inferences, because the available evidence was not prospectively collected for this purpose. (3) The data analysis relied on a composite variable labeled 'suicidality', an unvalidated, inappropriate surrogate. Specific criticisms of analytic procedures and inferences are presented. The failure of the FDA's post-marketing surveillance system is reviewed. The data necessary for objective evaluations of possible post-marketing harm cannot be gathered by the current process. Proper prospective post-marketing surveillance by linked computerized medical records is a crucial issue that deserves major public and political attention and prompt action.

  8. Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.

    Science.gov (United States)

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-07-08

    Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

  9. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  10. Transient insomnia versus chronic insomnia: a comparison study of sleep-related psychological/behavioral characteristics.

    Science.gov (United States)

    Yang, Chien-Ming; Lin, Shih-Chun; Cheng, Chung-Ping

    2013-10-01

    Vulnerability to transient insomnia is regarded as a predisposing factor for chronic insomnia. However, most individuals with transient insomnia do not develop chronic insomnia. The current study investigated the differential contributing factors for these two conditions to further the understanding of this phenomenon. Chronic insomnia patients and normal sleepers with high and low vulnerability to transient insomnia completed measures of pre-sleep arousal, dysfunctional sleep beliefs, and sleep-related safety behaviors. Both cognitive and somatic pre-sleep arousals were identified as significant predictors for transient insomnia. Dysfunctional beliefs regarding worry about insomnia and cognitive arousal were predictors for chronic insomnia. Sleep-related safety behavior, although correlated with insomnia severity, was not a significant predictor for both conditions. Dysfunctional beliefs associated with worry and losing control over sleep are the most critical factors in differentiating chronic insomnia from transient insomnia. These factors should be addressed to help prevent individuals with high sleep vulnerability from developing chronic sleep disturbance. © 2013 Wiley Periodicals, Inc.

  11. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

    2018-01-15

    Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

  12. Is mindfulness associated with insomnia after menopause?

    Science.gov (United States)

    Garcia, Marcelo Csermak; Pompéia, Sabine; Hachul, Helena; Kozasa, Elisa H; de Souza, Altay Alves L; Tufik, Sergio; Mello, Luiz Eugênio A M

    2014-03-01

    Mindfulness has been defined as being intentionally aware of internal and external experiences that occur at the present moment, without judgment. Techniques that develop mindfulness, such as meditation, have positive effects on reducing insomnia, a sleep disorder that is common both during and after menopause. Our aim was to establish whether postmenopausal women with insomnia are less mindful than postmenopausal women without sleep disorders. Postmenopausal women aged 50 to 65 years who did not use hormone therapy were recruited for the study. The sample included 14 women with insomnia and 12 women without insomnia or any other sleep disorder. The groups were comparable in age, schooling, and anxiety level. To assess mindfulness, we used the validated Mindful Attention Awareness Scale and the attentiveness domain of the Positive and Negative Affect Schedule-Expanded Form. Participants with insomnia were less mindful than healthy women. The level of mindfulness was able to discriminate the group with insomnia from the healthy group, with 71.4% accuracy. Postmenopausal women with insomnia are less mindful than women without insomnia. Mindfulness-based interventions, such as meditation, may be beneficial for postmenopausal insomnia.

  13. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    Science.gov (United States)

    Inagaki, Osamu

    2016-04-01

    Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

  14. Levodopa therapy with entacapone in daily clinical practice: results of a post-marketing surveillance study.

    Science.gov (United States)

    Kupsch, Andreas; Trottenberg, Thomas; Bremen, Dirk

    2004-01-01

    The catechol-O-methyl transferase inhibitor entacapone is given in combination with levodopa/dopa decarboxylase inhibitor for Parkinson's disease (PD) patients experiencing end-of-dose wearing-off. This 4-week post-marketing surveillance study was undertaken to assess patients' responses to levodopa combined with entacapone in a real clinical practice setting. Overall, 466 patients with idiopathic PD treated with levodopa and experiencing symptoms of wearing-off were recruited. Both physicians and patients recorded the response to therapy, including improvements and side-effects. Following initiation of entacapone treatment, the average daily levodopa dose was reduced from 510 to 453 mg. Physician assessment of entacapone efficacy was judged to be "very good" or "good" in 77.6% of the patients, and tolerability was considered to be "very good" or "good" in 92.4% of patients, with only 12 patients (2.6%) withdrawing from the study. Compared with baseline, there was a decrease in the mean duration of daily 'off' time from 3.0 to 1.3 h per day during the treatment period. Adverse events were in line with those previously reported, with diarrhoea being the most frequent event. The percentage of patients suffering from dyskinesia decreased from 46 to 34%, and of those patients still suffering from dyskinesia, the average daily duration of dyskinesia was reduced from 2.2 to 1.7 h. The use of adjunct dopamine agonists decreased from 67 to 59%. At study end, the percentage of patients who rated their quality of life (QoL) as "very good" or "good" increased from 12.1 to 51.7% and the percentage of patients who rated their QoL as "bad" or "very bad" decreased from 40 to 10.7%. In summary, the results of this survey conducted in real clinical practice support the findings of previous clinical trials demonstrating the efficacy and tolerability of entacapone, as well as the benefits of improved QoL, for patients achieved with entacapone.

  15. A Post-Marketing Surveillance Study to Evaluate Performance of the EXIMO™ Blood Glucose Monitoring System.

    Science.gov (United States)

    Chandnani, Sonia R; Ramakrishna, C D; Dave, Bhargav A; Kothavade, Pankaj S; Thakkar, Ashok S

    2017-05-01

    The performance of Blood Glucose Monitoring System (BGMS) is critical as the information provided by the system guide the patient or health care professional in making treatment decisions. However, besides evaluating accuracy of the BGMS in laboratory setting, it is equally important that the intended users (healthcare professionals and patients) should be able to achieve blood glucose measurements with similar level of high accuracy. To assess the performance of EXIMO™ (Meril Diagnostics Pvt. Ltd., Vapi, Gujarat, India) BGMS as per International Organization for Standardization (ISO) 15197:2013 section 8 user performance criteria. This was a non-randomized and post-marketing study conducted at a tertiary care centre of India. A total of 1005 patients with diabetes themselves performed fingertip blood glucose measurement using EXIMO™ BGMS. Immediately after capillary blood glucose measurement using the blood glucose monitoring system, venous blood sample from each patient was obtained by a trained technician which was assessed by reference laboratory method- Cobas Integra 400 plus (Roche Instrument Centre, Rotkreuz, Switzerland). All the blood glucose measurements assessed by EXIMO™ were compared with laboratory results. Performance of the system was assessed as per ISO 15197:2013 criteria using Bland-Altman plot, Parkes-Consensus Error Grid (CEG) and Surveillance Error Grid analyses (SEG). A total of 1005 patients participated in the study. Average age of the patients was 44.93±14.65 years. Evaluation of capillary fingertip blood glucose measurements demonstrated that 95.82% measurements fulfilled ISO 15197:2013 section 8 user performance criteria. All the results lie within clinically non-critical zones; Zone A (99.47%; n=1000) and Zone B (0.53%; n=05) of the CEG analysis. As per SEG analysis, majority of the results fell within "no-risk" zone (risk score 0 to 0.5; 90.42%). The result of the study confirmed that intended users are able to obtain accurate

  16. Valutazione della qualitá dei dati in uno studio post marketing

    Directory of Open Access Journals (Sweden)

    D. D’Alessandro

    2003-05-01

    Full Text Available

    Obiettivo: misurare l'affidabilita nella segnalazione
    di eventi avversi a vaccino nell'ambito di uno studio post-marketing sulla tollerabilita della vaccinazione antipneumococcica (AP in associazione con la vaccinazione antinfluenzale (AI nella popolazione anziana.


    Metodi: e stato predisposto un modello di regressione
    logistica per stimare gli OR tra la segnalazione di almeno un effetto collaterale locale (y ed alcune variabili individuali dei vaccinati (x1: eta .75 anni; x2: sesso; x3: allergie; x4: associazione AI+AP; x5: vivere solo; x6: patologie croniche. I medici aderenti al progetto (229 sono stati stratificati in cinque categorie in funzione dellfincidenza media di eventi avversi da loro registrata: 0% (29, 1-5%
    (68, 6-10% (50, 11-50% (72, .50% (10. Lo stesso modello di regressione e stato applicato ai quattro
    sotto-gruppi di vaccinati afferenti alle categorie di medici che hanno segnalato sintomi, per valutare la coerenza degli OR registrati nei gruppi.

    Risultati: tra i 29.086 vaccinati, l'f11,3% (3.278 ha segnalato almeno un evento avverso locale nelle
    72 ore successive alla vaccinazione: 9,9% tra i soggetti vaccinati con AI e 13,9% tra i vaccinati con
    AI+AP. I fattori significativamente associati all'faumento di rischio sono: AI+AP (OR 1,4; allergie (OR 1,3; patologie croniche (OR 1,3. L' applicazione del modello di regressione ai sotto-gruppi di vaccinati ha mostrato un trend negli OR per le categorie di medici che hanno segnalato dall'f1-5% fino all'f11- 50%, mostrando un'effettiva differenza di rischio dei pazienti.

    Tale coerenza non si e evinta nell'ultima categoria (.50%, dove tali fattori appaiono addiritura protettivi nei riguardi dei sintomi (AI+AP: OR 0,5; allergie: OR 0,7, o non associati
    (patologie croniche: OR 1,0.

    Conclusioni: il 4,3% dei medici arruolati nello studio (10 su 229 ha

  17. Organizational justice and insomnia: a prospective cohort study examining insomnia onset and persistence.

    Science.gov (United States)

    Hayashi, Toshio; Odagiri, Yuko; Takamiya, Tomoko; Ohya, Yumiko; Inoue, Shigeru

    2017-01-01

    Insomnia is one of the most common health problems and causes a large social burden. Psychosocial work-related factors are reported to be associated with both insomnia onset and insomnia persistence. However, the association between organizational justice (OJ) and insomnia remains unclear. The objective of this study was to examine the effect of OJ on insomnia persistence, as well as insomnia onset. A prospective cohort study with a 1-year observational period was conducted. Self-reported questionnaire data from 1588 employees were analyzed. OJ was measured using the Japanese version of the OJ questionnaire, which has four components (distributive, procedural, interpersonal, and informational). Insomnia was assessed with the Athens Insomnia Scale. Logistic regression analysis was used to explore the effects of OJ on insomnia. Among non-insomniac subjects at the baseline (n = 1236), low overall OJ was a risk of insomnia onset even after adjustment for lifestyle and work-related variables (adjusted odds ratio 0.66; 95% confidence interval 0.51-0.85). The procedural, interpersonal, and informational justice components were also associated with insomnia onset. Among insomniac subjects at the baseline (n = 352), low overall OJ, as well as the procedural and interpersonal justice components, was associated with insomnia persistence. Although these associations became insignificant after adjustment, the interpersonal justice component showed a marginally significant association with insomnia persistence (p = 0.058). OJ, especially interpersonal justice, was revealed as an associated factor for both insomnia onset and persistence. These findings may provide useful information for prevention of insomnia among working population.

  18. The nature of stable insomnia phenotypes.

    Science.gov (United States)

    Pillai, Vivek; Roth, Thomas; Drake, Christopher L

    2015-01-01

    We examined the 1-y stability of four insomnia symptom profiles: sleep onset insomnia; sleep maintenance insomnia; combined onset and maintenance insomnia; and neither criterion (i.e., insomnia cases that do not meet quantitative thresholds for onset or maintenance problems). Insomnia cases that exhibited the same symptom profile over a 1-y period were considered to be phenotypes, and were compared in terms of clinical and demographic characteristics. Longitudinal. Urban, community-based. Nine hundred fifty-four adults with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition based current insomnia (46.6 ± 12.6 y; 69.4% female). None. At baseline, participants were divided into four symptom profile groups based on quantitative criteria. Follow-up assessment 1 y later revealed that approximately 60% of participants retained the same symptom profile, and were hence judged to be phenotypes. Stability varied significantly by phenotype, such that sleep onset insomnia (SOI) was the least stable (42%), whereas combined insomnia (CI) was the most stable (69%). Baseline symptom groups (cross-sectionally defined) differed significantly across various clinical indices, including daytime impairment, depression, and anxiety. Importantly, however, a comparison of stable phenotypes (longitudinally defined) did not reveal any differences in impairment or comorbid psychopathology. Another interesting finding was that whereas all other insomnia phenotypes showed evidence of an elevated wake drive both at night and during the day, the 'neither criterion' phenotype did not; this latter phenotype exhibited significantly higher daytime sleepiness despite subthreshold onset and maintenance difficulties. By adopting a stringent, stability-based definition, this study offers timely and important data on the longitudinal trajectory of specific insomnia phenotypes. With the exception of daytime sleepiness, few clinical differences are apparent across stable phenotypes.

  19. Identifying At-Risk Individuals for Insomnia Using the Ford Insomnia Response to Stress Test.

    Science.gov (United States)

    Kalmbach, David A; Pillai, Vivek; Arnedt, J Todd; Drake, Christopher L

    2016-02-01

    A primary focus of the National Institute of Mental Health's current strategic plan is "predicting" who is at risk for disease. As such, the current investigation examined the utility of premorbid sleep reactivity in identifying a specific and manageable population at elevated risk for future insomnia. A community-based sample of adults (n = 2,892; 59.3% female; 47.9 ± 13.3 y old) with no lifetime history of insomnia or depression completed web-based surveys across three annual assessments. Participants reported parental history of insomnia, demographic characteristics, sleep reactivity on the Ford Insomnia in Response to Stress Test (FIRST), and insomnia symptoms. DSM-IV diagnostic criteria were used to determine insomnia classification. Baseline FIRST scores were used to predict incident insomnia at 1-y follow-up. Two clinically meaningful FIRST cutoff values were identified: FIRST ≥ 16 (sensitivity 77%; specificity 50%; odds ratio [OR] = 2.88, P insomnia onset, even after controlling for stress exposure and demographic characteristics. Of the incident cases, insomniacs with highly reactive sleep systems reported longer sleep onset latencies (FIRST ≥ 16: 65 min; FIRST ≥ 18: 68 min) than participants with nonreactive insomnia (FIRST insomnia based on trait sleep reactivity. The FIRST accurately identifies a focused target population in which the psychobiological processes complicit in insomnia onset and progression can be better investigated, thus improving future preventive efforts. © 2016 Associated Professional Sleep Societies, LLC.

  20. Insomnia among Adolescents: Implications for Counselors.

    Science.gov (United States)

    Morrison, Jack R.

    Adolescent underachievers may be, in fact, victims of insomnia or other types of sleep disorders. Insomnia is a greatly overlooked affliction that affects approximately 13% of the adolescent population, creating daytime side-effects that could impair intellectual functioning, such as imposing learning constraints. Poor sleepers among the…

  1. Nocturnal Regrets and Insomnia in Elderly People

    Science.gov (United States)

    Schmidt, Ralph E.; Renaud, Olivier; Van Der Linden, Martial

    2011-01-01

    Despite their importance for general health, emotion-related factors have rarely been considered in the etiology of late-life insomnia. This study explored the relations between impulsivity, regret experiences, use of different thought-control strategies, and insomnia severity in a sample of older adults whose age ranged from 51 to 98 years.…

  2. Causes and Treatment of Insomnia among Adolescents.

    Science.gov (United States)

    Morrison, Jack R.; And Others

    1985-01-01

    As much as 13 percent of the adolescent population may suffer from chronic insomnia, which can impair the victim's daily existence and affect personal life, school performance, and school attendance. The prevalence of adolescent insomnia, and its cause, diagnosis, and treatment are examined. (Author/CB)

  3. Music for insomnia in adults.

    Science.gov (United States)

    Jespersen, Kira V; Koenig, Julian; Jennum, Poul; Vuust, Peter

    2015-08-13

    Insomnia is a common sleep disorder in modern society. It causes reduced quality of life and is associated with impairments in physical and mental health. Listening to music is widely used as a sleep aid, but it remains unclear if it can actually improve insomnia in adults. To assess the effects of listening to music on insomnia in adults and to assess the influence of specific variables that may moderate the effect. We searched CENTRAL, PubMed, Embase, nine other databases and two trials registers in May 2015. In addition, we handsearched specific music therapy journals, reference lists of included studies, and contacted authors of published studies to identify additional studies eligible for inclusion, including any unpublished or ongoing trials. Randomised controlled trials and quasi-randomised controlled trials that compared the effects of listening to music with no treatment or treatment-as-usual on sleep improvement in adults with insomnia. Two authors independently screened abstracts, selected studies, assessed risk of bias, and extracted data from all studies eligible for inclusion. Data on pre-defined outcome measures were subjected to meta-analyses when consistently reported by at least two studies. We undertook meta-analyses using both fixed-effect and random-effects models. Heterogeneity across included studies was assessed using the I² statistic. We included six studies comprising a total of 314 participants. The studies examined the effect of listening to pre-recorded music daily, for 25 to 60 minutes, for a period of three days to five weeks.Based on the Grades of Recommendations, Assessment, Development and Evaluation (GRADE) approach, we judged the evidence from five studies that measured the effect of music listening on sleep quality to be of moderate quality. We judged the evidence from one study that examined other aspects of sleep (see below) to be of low quality. We downgraded the quality of the evidence mainly because of limitations in

  4. Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data.

    Science.gov (United States)

    Zhu, Xiao; Kruhlak, Naomi L

    2014-07-03

    Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure-activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI. Published by Elsevier Ireland Ltd.

  5. Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

    Science.gov (United States)

    Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

    2014-01-01

    Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

  6. Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data

    International Nuclear Information System (INIS)

    Zhu, Xiao; Kruhlak, Naomi L.

    2014-01-01

    Graphical abstract: - Abstract: Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure–activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI

  7. Predictability of Sleep in Patients with Insomnia

    Science.gov (United States)

    Vallières, Annie; Ivers, Hans; Beaulieu-Bonneau, Simon; Morin, Charles M.

    2011-01-01

    Study Objectives: To evaluate whether the night-to-night variability in insomnia follows specific predictable patterns and to characterize sleep patterns using objective sleep and clinical variables. Design: Prospective observational study. Setting: University-affiliated sleep disorders center. Participants: 146 participants suffering from chronic and primary insomnia. Measurements and Results: Daily sleep diaries were completed for an average of 48 days and self-reported questionnaires once. Three nights were spent in the sleep laboratory for polysomnographic (PSG) assessment. Sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time were derived from sleep diaries and PSG. Time-series diary data were used to compute conditional probabilities of having an insomnia night after 1, 2, or 3 consecutive insomnia night(s). Conditional probabilities were submitted to a k-means cluster analysis. A 3-cluster solution was retained. One cluster included 38 participants exhibiting an unpredictable insomnia pattern. Another included 30 participants with a low and decreasing probability to have an insomnia night. The last cluster included 49 participants exhibiting a high probability to have insomnia every night. Clusters differed on age, insomnia severity, and mental fatigue, and on subjective sleep variables, but not on PSG sleep variables. Conclusion: These findings replicate our previous study and provide additional evidence that unpredictability is a less prevalent feature of insomnia than suggested previously in the literature. The presence of the 3 clusters is discussed in term of sleep perception and sleep homeostasis dysregulation. Citation: Vallières A; Ivers H; Beaulieu-Bonneau S; Morin CM. Predictability of sleep in patients with insomnia. SLEEP 2011;34(5):609-617. PMID:21532954

  8. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  9. A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records

    Directory of Open Access Journals (Sweden)

    Yamamoto K

    2011-04-01

    Full Text Available Keiichi Yamamoto1, Shigemi Matsumoto2, Kazuhiro Yanagihara2, Satoshi Teramukai1, Masanori Fukushima1,2,31Department of Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital, Kyoto, Japan; 2Outpatient Oncology Unit, Kyoto University Hospital, Kyoto, Japan; 3Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, JapanPurpose: In conventional clinical studies, the cost of data management for the purposes of quality control tend to be high and collecting paper-based case report forms (CRFs can be burdensome, because paper-based CRFs must be developed and filled out for each clinical study protocol. Use of electronic health records (EHRs for this purpose could reduce costs and improve data quality in clinical studies. Kyoto University Hospital launched an EHR system in January 2005. At the same time, a replicate of that database was established for other purposes. At the Outpatient Oncology Unit of Kyoto University Hospital we developed a data-capture system that includes a cancer clinical database system and a data warehouse for outcomes studies. This system allows us to accumulate data at low cost and apply it to various uses in clinical or outcomes studies. Here we report on the application of this system to the post-marketing surveillance of drugs.Methods: We evaluated the availability of this system and identified problems for future development. With this system investigators can register cases for post-marketing surveillance, and the registered cases are listed on a screen. When CRFs for a particular case are required, data can be extracted from the list and CRFs are produced in PDF format.Results and conclusion: In this study we confirmed the applicability of our new system to post-marketing surveillance in providing prompt and efficient data exchange. We expect it to reduce the cost of data management and analysis and to improve the quality of data in post-marketing

  10. Three-Year Follow-Up of Insomnia and Hypnotics after Controlled Internet Treatment for Insomnia.

    Science.gov (United States)

    Blom, Kerstin; Jernelöv, Susanna; Rück, Christian; Lindefors, Nils; Kaldo, Viktor

    2016-06-01

    To investigate the long-term effects of therapist-guided Internet-based insomnia treatment on insomnia severity and sleep medication use, compared with active control. This study was an 8 week randomized controlled trial with follow-up posttreatment and at 6, 12, and 36 months, set at the Internet Psychiatry Clinic, Stockholm, Sweden. Participants were 148 media-recruited nondepressed adults with insomnia. Interventions were Guided Internet-based cognitive behavioral therapy for insomnia (ICBT-i) or active control treatment (ICBT-ctrl). Primary outcome was insomnia severity, measured with the Insomnia Severity Index. Secondary outcomes were sleep medication use and use of other treatments. The large pretreatment to posttreatment improvements in insomnia severity of the ICBT-i group were maintained during follow-up. ICBT-ctrl exhibited significantly less improvement posttreatment (between-Cohen d = 0.85), but after 12 and 36 months, there was no longer a significant difference. The within-group effect sizes from pretreatment to the 36-months follow-up were 1.6 (ICBT-i) and 1.7 (ICBT-ctrl), and 74% of the interviewed participants no longer had insomnia diagnosis after 36 mo. ICBT-ctrl used significantly more sleep medication (P = 0.017) and underwent significantly more other insomnia treatments (P insomnia has long-term effects. After 36 months, the groups did not differ in insomnia severity, but ICBT-ctrl had used more sleep medication and undergone more other additional insomnia treatments during the follow-up period. The trial was registered, together with a parallel trial, at Clinicaltrials.gov as "Internet-CBT for Insomnia" registration ID: NCT01256099. © 2016 Associated Professional Sleep Societies, LLC.

  11. The Natural History of Insomnia: Acute Insomnia and First-onset Depression

    Science.gov (United States)

    Ellis, Jason G.; Perlis, Michael L.; Bastien, Célyne H.; Gardani, Maria; Espie, Colin A.

    2014-01-01

    Study Objectives: While many studies have examined the association between insomnia and depression, no studies have evaluated these associations (1) within a narrow time frame, (2) with specific reference to acute and chronic insomnia, and (3) using polysomnography. In the present study, the association between insomnia and first-onset depression was evaluated taking into account these considerations. Design: A mixed-model inception design. Setting: Academic research laboratory. Participants: Fifty-four individuals (acute insomnia [n = 33], normal sleepers [n = 21]) with no reported history of a sleep disorder, chronic medical condition, or psychiatric illness. Interventions: N/A. Measurements and Results: Participants were assessed at baseline (2 nights of polysomnography and psychometric measures of stress and mood) and insomnia and depression status were reassessed at 3 months. Individuals with acute insomnia exhibited more stress, poorer mood, worse subjective sleep continuity, increased N2 sleep, and decreased N3 sleep. Individuals who transitioned to chronic insomnia exhibited (at baseline) shorter REM latencies and reduced N3 sleep. Individuals who exhibited this pattern in the transition from acute to chronic insomnia were also more likely to develop first-onset depression (9.26%) as compared to those who remitted from insomnia (1.85%) or were normal sleepers (1.85%). Conclusion: The transition from acute to chronic insomnia is presaged by baseline differences in sleep architecture that have, in the past, been ascribed to Major Depression, either as heritable traits or as acquired traits from prior episodes of depression. The present findings suggest that the “sleep architecture stigmata” of depression may actually develop over the course transitioning from acute to chronic insomnia. Citation: Ellis JG; Perlis ML; Bastien CH; Gardani M; Espie CA. The natural history of insomnia: acute insomnia and first-onset depression. SLEEP 2014;37(1):97-106. PMID

  12. Eszopiclone treatment for insomnia: effect size comparisons in patients with primary insomnia and insomnia with medical and psychiatric comorbidity.

    Science.gov (United States)

    Krystal, Andrew D; McCall, W Vaughn; Fava, Maurizio; Joffe, Hadine; Soares, Claudio N; Huang, Holly; Grinell, Todd; Zummo, Jacqueline; Spalding, William; Marshall, Randall

    2012-01-01

    The purpose of this post hoc analysis was to compare the treatment effect size of eszopiclone 3 mg for insomnia in patients with a diagnosis of primary insomnia and in several of the psychiatric and medical conditions that are most commonly comorbid with insomnia. Data were analyzed from 5 large, multicenter, randomized, double-blind, placebo-controlled studies of adult outpatients of at least 1 month duration published between 2006 and 2009. Diary-derived indices of sleep and daytime functioning and the Insomnia Severity Index were compared for patients with primary insomnia (DSM-IV-TR criteria, n = 828) and for those with insomnia comorbid with major depressive disorder (MDD, DSM-IV-TR criteria, n = 545), generalized anxiety disorder (GAD, DSM-IV-TR criteria, n = 595), perimenopause/postmenopause (Stages of Reproductive Aging Workshop criteria, n = 410), and rheumatoid arthritis (American College of Rheumatology criteria, n = 153). Cohen d effect sizes were calculated for each individual study as the between-treatment difference score divided by the pooled standard deviation. Effect sizes ranged from 0.40 to 0.69 (small-medium) as early as week 1 and were maintained at 0.26-0.63 at week 4 for sleep latency, wake time after sleep onset, and total sleep time. Sleep latency and total sleep time effect sizes increased from week 1 to week 4 in the primary insomnia group. At week 4, effect sizes on all 3 parameters and the Insomnia Severity Index tended to be highest for the primary insomnia patients and tended to be lowest for patients with comorbid GAD and MDD. The effect sizes for daytime functioning were small for all insomnia patient groups. Eszopiclone 3 mg is an effective treatment for insomnia across 5 clinically diverse patient populations; however, magnitude of effect is mediated by underlying comorbidity and their treatments, with largest measures of effect seen in primary insomnia and lowest in MDD and GAD. These consistent results, and the fact that

  13. Insomnia in women approaching menopause: Beyond perception.

    Science.gov (United States)

    Baker, Fiona C; Willoughby, Adrian R; Sassoon, Stephanie A; Colrain, Ian M; de Zambotti, Massimiliano

    2015-10-01

    The menopausal transition is marked by increased prevalence in disturbed sleep and insomnia, present in 40-60% of women, but evidence for a physiological basis for their sleep complaints is lacking. We aimed to quantify sleep disturbance and the underlying contribution of objective hot flashes in 72 women (age range: 43-57 years) who had (38 women), compared to those who had not (34 women), developed clinical insomnia in association with the menopausal transition. Sleep quality was assessed with two weeks of sleep diaries and one laboratory polysomnographic (PSG) recording. In multiple regression models controlling for menopausal transition stage, menstrual cycle phase, depression symptoms, and presence of objective hot flashes, a diagnosis of insomnia predicted PSG-measured total sleep time (p insomnia had, on average, 43.5 min less PSG-measured sleep time (p insomnia reported more WASO (p = 0.002), more night-to-night variability in WASO (p insomnia in the approach to menopause have a measurable sleep deficit, with almost 50% of the sample having less than 6h of sleep. Compromised sleep that develops in the context of the menopausal transition should be addressed, taking into account unique aspects of menopause like hot flashes, to avoid the known negative health consequences associated with insufficient sleep and insomnia in midlife women. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch® capsules 2.5 μg in 3,762 hemodialysis patients with intractable pruritus

    Directory of Open Access Journals (Sweden)

    Kozono H

    2018-01-01

    Full Text Available Hideki Kozono,* Hiroshi Yoshitani,* Ryoko Nakano* Pharmaceutical and Medical Device Vigilance Department, Toray Industries, Inc., Tokyo, Japan *The authors contributed equally to this work Background: Intractable pruritus in hemodialysis patients can significantly decrease their quality of life and is also associated with poor vital prognosis. Although combined multiple causes of intractable pruritus in these patients have been identified, no existing treatments are proven to be sufficiently effective. We conducted a post-marketing surveillance to follow-up and assess the safety and efficacy of nalfurafine, a selective κ-opioid receptor agonist, for the treatment of intractable pruritus in patients undergoing hemodialysis. Patients and methods: Hemodialysis patients with intractable pruritus from institutions in Japan who received oral nalfurafine hydrochloride between January 2010 and December 2013 were enrolled in the surveillance. Surveillance was completed in July 2015. Safety data during 1 year after nalfurafine treatment onset, and efficacy data of nalfurafine evaluating the first 12-week treatment period and the following period until 1 year after the initial dose of nalfurafine (using global assessment of the itch improvement by the physician, Visual Analog Scale, and the Shiratori’s severity scores were collected and analyzed. Results: In total, 3,762 patients were analyzed for safety. Adverse drug reactions were experienced by 402/3,762 (10.69% patients. The most frequent adverse drug reactions were insomnia (127/3,762 [3.38%] patients, constipation (34 [0.90%], somnolence (32 [0.85%], dizziness (23 [0.61%], nausea (13 [0.35%], and malaise (9 [0.24%]. No patients developed dependence on nalfurafine. Nalfurafine was effective in 82.50% (2,880/3,491 of patients during the first 12 weeks and in 84.95% (2,167/2,551 on treatment during the subsequent period until 1 year after nalfurafine treatment initiation. Statistically significant

  15. Insomnia and the Performance of US Workers: Results from the America Insomnia Survey

    Science.gov (United States)

    Kessler, Ronald C.; Berglund, Patricia A.; Coulouvrat, Catherine; Hajak, Goeran; Roth, Thomas; Shahly, Victoria; Shillington, Alicia C.; Stephenson, Judith J.; Walsh, James K.

    2011-01-01

    Study Objectives: To estimate the prevalence and associations of broadly defined (i.e., meeting full ICD-10, DSM-IV, or RDC/ICSD-2 inclusion criteria) insomnia with work performance net of comorbid conditions in the America Insomnia Survey (AIS). Design/Setting: Cross-sectional telephone survey. Participants: National sample of 7,428 employed health plan subscribers (ages 18+). Interventions: None. Measurements and Results: Broadly defined insomnia was assessed with the Brief Insomnia Questionnaire (BIQ). Work absenteeism and presenteeism (low on-the-job work performance defined in the metric of lost workday equivalents) were assessed with the WHO Health and Work Performance Questionnaire (HPQ). Regression analysis examined associations between insomnia and HPQ scores controlling 26 comorbid conditions based on self-report and medical/pharmacy claims records. The estimated prevalence of insomnia was 23.2%. Insomnia was significantly associated with lost work performance due to presenteeism (χ21 = 39.5, P insomnia with presenteeism equivalent to 11.3 days of lost work performance. This estimate decreased to 7.8 days when controls were introduced for comorbid conditions. The individual-level human capital value of this net estimate was $2,280. If we provisionally assume these estimates generalize to the total US workforce, they are equivalent to annualized population-level estimates of 252.7 days and $63.2 billion. Conclusions: Insomnia is associated with substantial workplace costs. Although experimental studies suggest some of these costs could be recovered with insomnia disease management programs, effectiveness trials are needed to obtain precise estimates of return-on-investment of such interventions from the employer perspective. Citation: Kessler RC; Berglund PA; Coulouvrat C; Hajak G; Roth T; Shahly V; Shillington AC; Stephenson JJ; Walsh JK. Insomnia and the performance of US workers: results from the America Insomnia Survey.SLEEP 2011;34(9):1161-1171. PMID

  16. Treatment of Insomnia, Insomnia Symptoms, and Obstructive Sleep Apnea During and After Menopause: Therapeutic Approaches

    OpenAIRE

    Tal, Joshua Z.; Suh, Sooyeon A.; Dowdle, Claire L.; Nowakowski, Sara

    2015-01-01

    Understanding sleep complaints among menopausal women is an emerging area of clinical and research interest. Several recent reviews have focused on mechanisms of menopausal insomnia and symptoms. In this review, we present a discussion on the most relevant and recent publications on the treatment of sleep disorders for menopausal women, with a focus on menopause-related insomnia, insomnia symptoms, and obstructive sleep apnea. We discuss both nonpharmacological and pharmacological treatments,...

  17. The Natural History of Insomnia: Acute Insomnia and First-onset Depression

    OpenAIRE

    Ellis, Jason; Perlis, Michael; Bastien, Célyne; Gardani, Maria; Espie, Colin

    2014-01-01

    Study Objectives: While many studies have examined the association between insomnia and depression, no studies have evaluated these associations 1) within a narrow time frame, 2) with specific reference to acute & chronic insomnia, and 3) using polysomnography. In the present study, the association between insomnia and first-onset depression was evaluated taking into account these considerations. \\ud \\ud Design: A mixed-model inception design. \\ud \\ud Setting: Academic research laboratory. \\u...

  18. Insomnia

    Science.gov (United States)

    ... of Sleep Medicine and Disorders; 3(5): 1061. Taylor, D.J., Lichstein, K.L., Durrence, H.H., ... of Obstetrics & Gynecology, Department of Psychiatry & Behavioral Sciences, University of Texas Medical Branch All material contained on ...

  19. Insomnia

    Science.gov (United States)

    ... family doctor may ask you: Questions about your sleep habits. This includes when you go to bed and ... include caffeine, some medicines, and alcohol. Adopt better sleep habits. Follow a bedtime routine, keep your room dark ...

  20. Insomnia

    Science.gov (United States)

    ... bedroom, and hiding the clock from view. Relaxation training. This method helps you calm your mind and body. Approaches include meditation, imagery, muscle relaxation and others. Remaining passively awake. ...

  1. Hazards of insomnia and the effects of acupuncture treatment on insomnia.

    Science.gov (United States)

    Lin, Yu-fang; Liu, Zhi-dan; Ma, Wen; Shen, Wei-dong

    2016-05-01

    Insomnia is a common disease in modern society; it is made worse by increasingly fierce competition in the workplace and elsewhere, along with rapid economic and social development. Sleep disorders can result in changes in serum biomarkers and decreased immunity, and may cause maladies such as depression and cardiac diseases, as well as many other somatic symptoms. Western medications for treating insomnia can easily lead to addiction and other adverse effects. Fortunately, acupuncture can ease the symptoms of insomnia. This review summarizes the hazards associated with insomnia and the use of acupuncture in its treatment. Furthermore, the authors introduce an effective and low-cost method of treating insomnia with acupuncture. This review indicates that insomnia poses a major threat to mental health through its effects on serum components, heart function and the immune system of patients, which may lead to other physiological disorders. Anxiety and depression are the two main negative emotions affected by insomnia. Acupuncture, which has showed effectiveness against insomnia and its complications, may be an effective and complementary method for the treatment of insomnia and associated maladies.

  2. Music for insomnia in adults

    DEFF Research Database (Denmark)

    Jespersen, Kira V; Koenig, Julian; Jennum, Poul

    2015-01-01

    the effects of listening to music with no treatment or treatment-as-usual on sleep improvement in adults with insomnia. DATA COLLECTION AND ANALYSIS: Two authors independently screened abstracts, selected studies, assessed risk of bias, and extracted data from all studies eligible for inclusion. Data on pre...... a total of 314 participants. The studies examined the effect of listening to pre-recorded music daily, for 25 to 60 minutes, for a period of three days to five weeks.Based on the Grades of Recommendations, Assessment, Development and Evaluation (GRADE) approach, we judged the evidence from five studies...... of the size of about one standard deviation in favour of the intervention compared to no treatment or treatment-as-usual.Only one study (N = 50; low-quality evidence) reported data on sleep onset latency, total sleep time, sleep interruption, and sleep efficiency. However, It found no evidence to suggest...

  3. Post-marketing surveillance of anti-malarial medicines used in Malawi

    OpenAIRE

    Chikowe, Ibrahim; Osei-Safo, Dorcas; Harrison, Jerry JEK; Konadu, Daniel Y; Addae-Mensah, Ivan

    2015-01-01

    Background The growing concern over the extent of anti-malarial medicine resistance in sub-Saharan Africa, driven largely by administration of sub-therapeutic doses derived from falsified and substandard medicines necessitates regular monitoring of the quality of these medicines to avert any potential public health disaster. This study aimed at determining the active pharmaceutical ingredient (API) content of anti-malarial medicines available in Malawi with respect to the manufacturers? label...

  4. Insomnia Self-Management in Heart Failure

    Science.gov (United States)

    2018-01-05

    Cardiac Failure; Heart Failure; Congestive Heart Failure; Heart Failure, Congestive; Sleep Initiation and Maintenance Disorders; Chronic Insomnia; Disorders of Initiating and Maintaining Sleep; Fatigue; Pain; Depressive Symptoms; Sleep Disorders; Anxiety

  5. Insomnia: clinical experience with zolpidem (sanval

    Directory of Open Access Journals (Sweden)

    Yakov Iosifovich Levin

    2010-01-01

    Full Text Available The paper describes the present view of the problem of insomnia and gives a classification of sleep disorders and basic methods for their drug and non-drug therapy. Emphasis is placed on the role of the objective sleep study - polysomnography. The use of the current hypnotics belonging to a three Zs group and the minimization of administration of benzodiazepines are most important in pharmacotherapy for insomnia. The results of a clinical polysomnographic study of the effect of Zolpidem (Sanval in patients with insomnia are presented. The subjective evaluation of the beneficial effect of a 10-day course of Sanval is confirmed by the objective studies of the sleep pattern undergoing positive changes in the most important indicators, such as the process of falling asleep, the time of intrasleep awakenings, and the duration of Δ-sleep. The high safety and good tolerability of Sanval permit the latter to be assessed as an effective agent for the treatment of insomnia.

  6. Childhood adversity and insomnia in adolescence.

    Science.gov (United States)

    Wang, Yan; Raffeld, Miriam R; Slopen, Natalie; Hale, Lauren; Dunn, Erin C

    2016-05-01

    The study aims to evaluate the association between exposure to childhood adversity and insomnia, with an emphasis on the role of adversity type, timing, and accumulation (i.e., the number of specific types of adversities the child reported being exposed to). Our analytic sample comprised 9582 adolescents from the National Comorbidity Survey Replication Adolescent Supplement (NCS-A), a nationally representative population-based sample. We examined the association between 18 different types of retrospectively reported adversities (capturing interpersonal violence, accidents and injuries, social network or witnessing events, and other adverse events) and risk of self-reported past-year insomnia. We also examined whether the age at first exposure to adversity was associated with the risk of insomnia, and whether exposure to a greater number of different types of adversities (ie, accumulation) conferred an elevated risk of insomnia. In addition, we performed a sensitivity analysis excluding adolescents with a past-year diagnosis of major depression, dysthymia, post-traumatic stress disorder (PTSD), or generalized anxiety disorder. Almost one-third of adolescents reported insomnia, with a higher prevalence among girls and those from racial/ethnic minority groups. Adolescents exposed to at least one childhood adversity of any type (59.41%) were more likely than their nonexposed peers to experience insomnia (across adversities, prevalence ratios (PRs) ranged from 1.31 to 1.89). Risk of insomnia differed based on the age at first exposure to adversity as well as the type of adversity. Adolescents exposed to a greater number of different types of adversities had a higher risk of insomnia compared to those experiencing fewer adversities. These results were similar, by and large, to those obtained after excluding adolescents with at least one of the four past-year psychiatric disorders. Exposure to adversity confers an elevated risk of insomnia. This association varied by type

  7. Predictability of Sleep in Patients with Insomnia

    OpenAIRE

    Vallières, Annie; Ivers, Hans; Beaulieu-Bonneau, Simon; Morin, Charles M.

    2011-01-01

    Study Objectives: To evaluate whether the night-to-night variability in insomnia follows specific predictable patterns and to characterize sleep patterns using objective sleep and clinical variables. Design: Prospective observational study. Setting: University-affiliated sleep disorders center. Participants: 146 participants suffering from chronic and primary insomnia. Measurements and Results: Daily sleep diaries were completed for an average of 48 days and self-reported question...

  8. Prevalence of insomnia and related impact.

    Science.gov (United States)

    Manjavong, Manchumad; Limpawattana, Panita; Mairiang, Pisaln; Anutrakulchai, Sirirat

    2016-08-01

    Background Sleep problem is a common geriatric condition that can result in various outcomes, both physical and mental, that reduce quality of life. The studies regarding the prevalence and impact of insomnia on daily activities in Thailand in pre-elderly and elderly adults are few. Objectives The primary objective of this study was to determine the prevalence of insomnia among pre-elderly and elderly populations and the secondary objective was to study the impact of insomnia on their daily lives. Methods This study included the participants from the urban middle class in the pre-retirement age of 50 years or older adults who worked for Khon Kaen University (KKU), Khon Kaen, Thailand, and their elderly relatives. Information on baseline characteristics, sleep problems, and outcomes were collected. Descriptive analytical statistics were used to analyze baseline data. Multivariate analysis was used to analyze associated factors of the impact of insomnia. Results A total of 491 participants were recruited. The prevalence of insomnia was 60%. The significant consequences related to insomnia were feeling unrefreshed (adjusted odds ratio (AOD) 2.22, 95% confidence interval (CI) 1.44-3.04), daytime sleepiness (AOD 2.04, 95% CI 1.29-3.22), need for a sedative drug (AOD 4.23, 95% CI 2.09-8.55), depression (AOD 4.74, 95% CI 1.73-13), and impaired attention (AOD 2.29, 95% CI 1.52-3.45). Conclusions Insomnia was found in the majority of pre-elderly and elderly participants and resulted in several poor outcomes. Early detection of insomnia may prevent some inevitable outcomes.

  9. [The newest epidemiology trend of insomnia].

    Science.gov (United States)

    Ikeda, Maki; Kaneita, Yoshitaka

    2014-03-01

    Sleep disturbance such as insomnia is one of common complaint among adults in developed countries. Insomnia induces sleepiness and drowsiness, resulting in a reduction of working efficiency in the daytime. Drivers in the transportation system and machine operators could cause serious industrial accidents if they have sleep disturbances. Recent studies reported that approximately 20% of Japanese population had sleep disturbances. Here we provide a general account of sleep disturbance about Japanese population.

  10. Pharmacotherapy for Insomnia in Primary Care

    OpenAIRE

    Smith, Emily; Narang, Puneet; Enja, Manasa; Lippmann, Steven

    2016-01-01

    Pharmacotherapy for insomnia in primary care settings can be challenging. Frequently, there are multiple coexisting medical and psychiatric conditions, drug interactions, concern regarding use of habit-forming sleep aids, and paucity of time in office visits to discuss management of sleep difficulties. This article reports the results of a literature search related to pharmacotherapy for insomnia and presents 4 clinical vignettes with corresponding treatment options.

  11. Insomnia in patients with unexplained chest pain.

    Science.gov (United States)

    Belleville, Geneviève; Foldes-Busque, Guillaume; Poitras, Julien; Chauny, Jean-Marc; Diodati, Jean G; Fleet, Richard; Marchand, André

    2014-01-01

    The current study was designed (1) to assess insomnia symptoms and sleep-related beliefs in a population of patients presenting in emergency department with unexplained chest pain (UCP) and (2) to examine the associations between insomnia and pain. This is a report of secondary data from a cross-sectional study performed in the emergency department of 2 academic hospitals. Patients with UCP seen in an emergency department were assessed using sleep questionnaires and the Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders, fourth edition. Nearly every second patient with UCP (44%) seen in an emergency department suffered from clinically significant insomnia symptoms. Most patients with an anxiety or a mood disorder had insomnia, but a minority of patients with insomnia had an anxiety or a mood disorder. Insomniacs with an anxiety disorder were similar to insomniacs without comorbid anxiety for sleep-related beliefs and depressive symptoms, and both groups of insomniacs reported more depressive symptoms and faulty beliefs than both groups of good sleepers, i.e., either with or without an anxiety disorder. Results from regression analyses revealed that insomnia was associated with pain on univariate regression analysis and accounted for 1.3% of the variance in both pain intensity and interference. However, this association was rendered nonsignificant when additional variables were added to the model. Insomnia symptoms are an important, but often disregarded, feature present in a significant proportion of patients with UCP. As insomnia showed stronger associations with pain than anxiety or depression, it may represent an important factor contributing to the development and recurrence of UCP. Copyright © 2014 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

  12. The natural history of insomnia: acute insomnia and first-onset depression.

    Science.gov (United States)

    Ellis, Jason G; Perlis, Michael L; Bastien, Célyne H; Gardani, Maria; Espie, Colin A

    2014-01-01

    While many studies have examined the association between insomnia and depression, no studies have evaluated these associations (1) within a narrow time frame, (2) with specific reference to acute and chronic insomnia, and (3) using polysomnography. In the present study, the association between insomnia and first-onset depression was evaluated taking into account these considerations. A mixed-model inception design. Academic research laboratory. Fifty-four individuals (acute insomnia [n = 33], normal sleepers [n = 21]) with no reported history of a sleep disorder, chronic medical condition, or psychiatric illness. N/A. Participants were assessed at baseline (2 nights of polysomnography and psychometric measures of stress and mood) and insomnia and depression status were reassessed at 3 months. Individuals with acute insomnia exhibited more stress, poorer mood, worse subjective sleep continuity, increased N2 sleep, and decreased N3 sleep. Individuals who transitioned to chronic insomnia exhibited (at baseline) shorter REM latencies and reduced N3 sleep. Individuals who exhibited this pattern in the transition from acute to chronic insomnia were also more likely to develop first-onset depression (9.26%) as compared to those who remitted from insomnia (1.85%) or were normal sleepers (1.85%). The transition from acute to chronic insomnia is presaged by baseline differences in sleep architecture that have, in the past, been ascribed to Major Depression, either as heritable traits or as acquired traits from prior episodes of depression. The present findings suggest that the "sleep architecture stigmata" of depression may actually develop over the course transitioning from acute to chronic insomnia.

  13. Insomnia patients' help-seeking experiences.

    Science.gov (United States)

    Cheung, Janet M Y; Bartlett, Delwyn J; Armour, Carol L; Glozier, Nicholas; Saini, Bandana

    2014-03-04

    Timely access to appropriate treatment is important for optimizing insomnia management. To date, little is known about insomnia patients' treatment experiences or how they access and engage with the available health care resources. This study sought to capture the help-seeking experiences and behavioral patterns of patients with insomnia who are seeking or receiving specialist care. A purposive sample of 26 insomnia patients from specialist sleep and mental health clinics located in metropolitan New South Wales, Australia was recruited. Participants completed a brief questionnaire, followed by an in-depth, semi-structured interview. Interviews were digitally recorded, transcribed verbatim, and analyzed using framework analysis. Three key themes emerged from the data: patients' sleep beliefs, treatment beliefs, and accessing specialized care. The findings show that daytime symptoms arising from insomnia serve as important illness cues for patients to seek medical help. In addition, participants' treatment pathways highlight factors that prevent the widespread use of cognitive behavioral therapy for insomnia (CBT-I), including limited awareness about CBT-I, tentative referral mechanisms, limited service providers, and the high cost of CBT-I.

  14. Acceptability of behavioral treatments for insomnia.

    Science.gov (United States)

    Bluestein, Daniel; Healey, Amanda C; Rutledge, Carolyn M

    2011-01-01

    Behavioral treatments for insomnia are safe and efficacious but may not be embraced by patients in primary care. Understanding factors associated with acceptability can enhance successful use of these modalities. The objective of this study was to identify demographic and clinical/psychosocial correlates of behavioral insomnia treatment acceptability. This nonexperimental, inventory-based, cross-sectional study enrolled patients from a hospital-sponsored primary care clinic and 2 urban academic family practices. Participants (n = 236) were 18 years of age or older who had clinically significant insomnia (Insomnia Severity Index score ≥ 8) and were recruited consecutively at these sites. A study coordinator obtained informed consent then distributed survey materials. Participants received a $10 honorarium. The main outcome measure was the Acceptability Insomnia Treatment Acceptability Scale-Behavioral subscale (ITAS-B). Only acceptability of medications (r = 0.259) and dysfunctional beliefs (r = 0.234) scores had significant bivariate correlations with ITAS-B scores (P insomnia therapies. Interest in behavioral and medication treatments are not mutually exclusive. However, the modest variance reported here suggests other factors impact acceptance of behavioral treatments.

  15. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.

    Science.gov (United States)

    Bouvy, Jacoline C; Blake, Kevin; Slattery, Jim; De Bruin, Marie L; Arlett, Peter; Kurz, Xavier

    2017-12-01

    Regulatory agencies and other stakeholders increasingly rely on data collected through registries to support their decision-making. Data from registries are a cornerstone of post-marketing surveillance for monitoring the use of medicines in clinical practice. This study was aimed at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. European Public Assessment Reports were consulted to identify products for which a request for a registry was made as a condition of the marketing authorisation. All centrally authorised products that received a positive opinion of the EMA Committee for Medicinal Products for Human Use between 1 January 2005 and 31 December 2013 were included. Data regarding registry design and experiences were collected from EMA electronic record keeping systems. Of 392 products that received a positive Committee for Medicinal Products for Human Use opinion during 2005-2013, 31 registries were requested for 30 products in total. Sixty-five percent were product registries whereas 35% were disease registries and 71% of the registries had a primary safety objective. Most commonly reported issues with registries were delayed time to start and low patient accrual rates. The delays found in getting new registries up and running support the need to improve the timeliness of data collection in the post-marketing setting. Methodological challenges met in conducting this study highlighted the need for a clarification of definitions and epidemiological concepts around patient registries. The results will inform the EMA Patient Registry initiative to support use of existing patient registries for the post-authorisation benefit-risk monitoring of medicinal products. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety © 2017 John Wiley & Sons, Ltd. © 2017 Commonwealth of Australia. Pharmacoepidemiology

  16. The association of mothers' and fathers' insomnia symptoms with school-aged children's sleep assessed by parent report and in-home sleep-electroencephalography.

    Science.gov (United States)

    Urfer-Maurer, Natalie; Weidmann, Rebekka; Brand, Serge; Holsboer-Trachsler, Edith; Grob, Alexander; Weber, Peter; Lemola, Sakari

    2017-10-01

    Sleep plays an essential role for children's well-being. Because children's sleep is associated with parental sleep patterns, it must be considered in the family context. As a first aim of the present study, we test whether parental insomnia symptoms are related to children's in-home sleep-electroencephalography (EEG). Second, we examine the association between parental insomnia symptoms and maternal and paternal perception of children's sleep using actor-partner interdependence models. A total of 191 healthy children enrolled in public school and aged 7-12 years took part in the study. Ninety-six were formerly very preterm born children. Children underwent in-home sleep-EEG, and parents reported children's sleep-related behavior by using the German version of the Children's Sleep Habits Questionnaire. Further, parents completed the Insomnia Severity Index to report their own insomnia symptoms. Maternal but not paternal insomnia symptoms were related to less children's EEG-derived total sleep time, more stage 2 sleep, less slow wave sleep, later sleep onset time, and later awakening time. Mothers' and fathers' own insomnia symptoms were related to their reports of children's bedtime resistance, sleep duration, sleep anxiety, night wakings, and/or daytime sleepiness. Moreover, maternal insomnia symptoms were associated with paternal reports of children's bedtime resistance, sleep anxiety, and sleep-disordered breathing. The associations between parental insomnia symptoms and parents' perception of children's sleep could not be explained by children's objectively measured sleep. Mothers' insomnia symptoms and children's objective sleep patterns are associated. Moreover, the parents' own insomnia symptoms might bias their perception of children's sleep-related behavior problems. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. Insomnia and generalized anxiety disorder: effects of cognitive behavior therapy for gad on insomnia symptoms.

    Science.gov (United States)

    Bélanger, Lynda; Morin, Charles M; Langlois, Frédéric; Ladouceur, Robert

    2004-01-01

    Although clinical practice suggests that sleep complaints are frequent among patients with generalized anxiety disorder (GAD), frequency, severity, types of insomnia complaints, and relationship to GAD diagnosis severity in patients diagnosed using Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria are not well documented. Clinical data about the impact on insomnia symptoms of treating GAD worries are also lacking. The present study examined these aspects in 44 GAD patients who participated in a treatment study specifically addressing excessive worries through CBT interventions. All patients were assessed using a structured clinical interview and the Anxiety Disorder Interview Schedule-IV (ADIS-IV). They also completed anxiety and insomnia inventories, including the Insomnia Severity Index (ISI), a self-report measure which assesses insomnia type, severity and interference with daily life. Among this sample, 47.7% reported difficulties initiating sleep, 63.6% reported difficulties maintaining sleep, and 56.8% complained of waking too early in the morning. The majority of these patients (86.5%) reported never having experienced insomnia without having excessive worries. However, insomnia severity and GAD severity were not correlated. In this sample, patients with severe GAD did not necessarily report more severe insomnia symptoms. Regarding treatment impact on insomnia complaints, ISI post-treatment scores were significantly lower after treatment. Mean post-treatment scores almost reached ISI's "absence of clinical insomnia" category. Results indicate that this CBT package for GAD does have a significant impact on sleep quality even if sleep disturbances were not specifically addressed during treatment.

  18. Pain-related insomnia versus primary insomnia: a comparison study of sleep pattern, psychological characteristics, and cognitive-behavioral processes.

    Science.gov (United States)

    Tang, Nicole K Y; Goodchild, Claire E; Hester, Joan; Salkovskis, Paul M

    2012-06-01

    Recent applications of cognitive-behavior therapy for primary insomnia in the management of pain-related insomnia are based on the implicit assumption that the 2 types of insomnia share the same presentation and maintaining mechanisms. The objectives of this study were to compare the characteristics of patients who have pain-related insomnia with those reporting primary insomnia and to identify psychological factors that predict pain-related insomnia. Chronic pain patients with concomitant insomnia (n=137; Pain-related Insomnia Group) completed a selection of questionnaires that measure sleep patterns, psychological attributes, and cognitive-behavioral processes associated with the persistence of insomnia. Their responses were compared with those of primary insomnia patients (n=33; Primary Insomnia Group), using 3 sets of multivariate analyses of covariance that took account of demographic differences. Hierarchical regression analyses were performed to identify predictors of insomnia severity among the chronic pain patients. The Pain-related Insomnia Group did not differ from the Primary Insomnia Group in their pattern and severity of sleep disturbance. The 2 groups were largely comparable in terms of their psychological characteristics, except that the Primary Insomnia Group was distinguishable from the Pain-related Insomnia Group by their greater tendency to worry. Patients in the Pain-related Insomnia Group reported levels of sleep-related anxiety and presleep somatic arousal that matched with those reported by patients in the Primary Insomnia Group. However, relative to patients in the Pain-related Insomnia Group, those in the Primary Insomnia Group reported more dysfunctional sleep beliefs and presleep cognitive arousal. In addition to pain intensity, depression, and presleep cognitive arousal were significant predictors of insomnia severity within the Pain-related Insomnia Group. There are more similarities than differences between the 2 types of insomnia

  19. Wake high-density electroencephalographic spatiospectral signatures of Insomnia

    NARCIS (Netherlands)

    Colombo, Michele A.; Ramautar, Jennifer R.; Wei, Yishul; Gomez-Herrero, Germán; Stoffers, Diederick; Wassing, Rick; Benjamins, Jeroen S.; Tagliazucchi, Enzo; van der Werf, Ysbrand; Cajochen, Christian; Van Someren, Eus J.W.

    2016-01-01

    Study Objectives: Although daytime complaints are a defining characteristic of insomnia, most EEG studies evaluated sleep only. We used high-density electroencephalography to investigate wake resting state oscillations characteristic of insomnia disorder (ID) at a fine-grained spatiospectral

  20. [Evaluation on acupuncture treatment of primary insomnia].

    Science.gov (United States)

    Sun, Jing-qing; Guo, Jing

    2010-04-01

    Acupuncture treatment of insomnia has been reported for many years, but its validity remains controversial up to now. In the present review, the authors took "Acupuncture", "Insomnia" as the key words to do a literature search from databases in both Chinese and English via computer retrieval system and also conducted a hand-made retrieval from journals of Chinese medicine as Chinese Acu-moxibustion, and collections of theses of the related academic conferences. Then, they made a systemic evaluation on the original articles from methodology, diagnosis, criteria for the enlisted and excluded patients, intervention methods of acupuncture and control groups, standards for assessing the curative efficacy, follow-up visit, etc. Of the retrieved 80 clinical articles, 20 are RCT (randomized controlled trails) composed of 1907 cases, including 4 high-quality trails and 16 lower-quality trails. Regarding the assessment of the therapeutic effect, measuring scales are often adopted in overseas studies, while in domestic researches, self-drawn standards are frequently used. In conclusion, there have had no high-quality clinical trails about acupuncture treatment of primary insomnia in China at the present, and the related evaluating methods could not definitely confirm the efficacy of acupuncture in relieving insomnia. Therefore, a strict and scientific clinical trail scheme being in line with evidence-based medicine is urgently needed in the coming studies on acupuncture treatment of primary insomnia.

  1. Maternal insomnia and children's family socialization environments.

    Science.gov (United States)

    Gregory, Alice M; Moffitt, Terrie E; Ambler, Antony; Arseneault, Louise; Houts, Renate M; Caspi, Avshalom

    2012-04-01

    To examine concurrent associations between maternal insomnia and different aspects of the family socialization environment. Mothers reported on their symptoms of insomnia in a private standardized interview and interviewers evaluated the family socialization environment using the Coder's Inventory. Assessments were conducted in participants' homes within the U.K. One thousand one hundred sixteen mothers of British children enrolled in the Environmental Risk (E-Risk) study were invited to participate when their children were aged 12 years. N/A. After controlling for family socioeconomic status (SES), mothers' relationship status, and maternal depression, maternal insomnia was associated with a poorer family socialization environment (β = -0.10, [95% confidence intervals (CI) = -0.16, -0.04], P socialization environment subscales were examined, after controlling for family SES, mothers' relationship status, and maternal depression, maternal insomnia was associated with greater chaos (β = 0.09, [95% CI = 0.03, 0.15], P = 0.002), greater child neglect (β = 0.13, [95% CI = 0.07, 0.18], P socialization environment. This finding emphasizes the need to consider insomnia in the family context.

  2. INSOMNIA AND CORRELATION WITH PSYCHOSOCIAL FACTORS IN PRIMARY HEALTH CARE

    OpenAIRE

    Made Gede Cahyadi Permana

    2013-01-01

    Insomnia is regarded as sleep disorder that most often affects people in the world, both in primary and in the presence of comorbid conditions. Based on those facts, insomnia could be a serious problem at the level of primary health care. General Practitioner should be able to diagnose insomnia and able to perform the appropriate treatment for the patient. Psychosocial factors may related to the degree of severity of insomnia, among others are health status, depression, dysfunctional beliefs ...

  3. Mendengarkan Murattal Al-Qur'an Untuk Menurunkan Tingkat Insomnia

    OpenAIRE

    Wulandari, Etik Dwi; Trimulyaningsih, Nita

    2015-01-01

    This research aimed to understand the effect of listening murattal Al-Qur'an to insomnia score. The hypothesis of this research is listening murattal Al-Qur'an can reduce insomnia level. Subjects participated in this research were two university students from Faculty of Psychology and Social Culture, major Psychology, Department of Psychology at the Islamic University of Indonesia, who were diagnosed with insomnia. The data was collected with KSPBJ - Insomnia Rating Scale, monitoring scale an...

  4. ‘Folk theories’ about the causes of insomnia

    OpenAIRE

    Harvey, Allison G.; Soehner, Adriane; Lombrozo, Tania; Bélanger, Lynda; Rifkin, Jamie; Morin, Charles M.

    2013-01-01

    The present study investigates ‘folk theories’ about the causes of insomnia. Participants with insomnia (n = 69) completed a qualitative and quantitative assessment of their folk theories. The qualitative assessment was to speak aloud for 1 minute in response to: ‘What do you think causes your insomnia?’. The quantitative assessment involved completing the ‘Causal Attributions of My Insomnia Questionnaire’ (CAM-I), developed for this study. The three most common folk theories for both the cau...

  5. Insomnia disorder: when sleep plays coy, aloof and disdainful ...

    African Journals Online (AJOL)

    Intermittent or acute insomnia is common and may sometimes require short term treatment with approved hypnotic agents. A diagnosis of insomnia disorder, however, indicates that poor night-time sleep is chronic and is accompanied by significant impairment of daytime functioning. Although insomnia disorder often co ...

  6. Cognitive Behavioral Therapy for Insomnia in Older Adults

    Science.gov (United States)

    Belanger, Lynda; LeBlanc, Melanie; Morin, Charles M.

    2012-01-01

    Insomnia is associated with significant morbidity and is often a persistent problem, particularly in older adults. It is important to attend to this complaint and not assume that it will remit spontaneously. In many cases, unfortunately, insomnia remains unrecognized and untreated, often because it is presumed that insomnia is an inevitable…

  7. Clinical practice guidelines for insomnia disorder | Malan | South ...

    African Journals Online (AJOL)

    To diagnose insomnia, it is required to evaluate the daytime and nocturnal symptoms, as well as psychiatric and medical history. The Diagnostic and Statistical Manual 5 Criteria (DSM-5) also provides guidelines and criteria to be followed when diagnosing insomnia disorder. Goals of treatment for insomnia disorder are to ...

  8. Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations

    Directory of Open Access Journals (Sweden)

    Wang C

    2018-04-01

    Full Text Available Can Wang,1,2 Qing-ping Shi,1,2 Feng Ding,2 Xiao-dong Jiang,1,2 Wei Tang,3 Mei-Ling Yu,1,2 Jian-Hua Zhu2 1Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People’s Republic of China; 2Faculty of Pharmacy, Bengbu Medical College, Bengbu, People’s Republic of China; 3Department of Pharmacy, Huaiyuan County Hospital of TCM in Anhui, Bengbu, People’s Republic of China Aim: To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening.Methods: This study used a prospective, nested case–control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening.Results: The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674, and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760 when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single

  9. Association between stress-related sleep reactivity and cognitive processes in insomnia disorder and insomnia subgroups: preliminary results.

    Science.gov (United States)

    Palagini, Laura; Faraguna, Ugo; Mauri, Mauro; Gronchi, Alessia; Morin, Charles M; Riemann, Dieter

    2016-03-01

    Stress-related sleep reactivity, sleep-related cognitions, and psychological factors play an important role in insomnia. The aim was to investigate their possible association in Insomnia Disorder, insomnia subgroups, and healthy subjects. The cross-sectional study consisted of 93 subjects who met diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and of 30 healthy subjects. Survey instruments included the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), Dysfunctional Beliefs about Sleep scale (DBAS), Beck Depression Inventory (BDI), and Zung Self-Rating Anxiety Scale (SAS). Descriptive statistics, Pearson correlations, χ(2)-test, and multiple linear regression were performed. FIRST and SAS best determined the insomnia subjects vs good sleepers (FIRST χ(2) = 109.6, p insomnia, stress-related sleep reactivity, and psychological factors, such as anxiety symptoms, may distinguish insomnia subjects from good sleepers; (2) sleep reactivity and sleep-related cognitions seem interrelated, unhelpful beliefs may affect the stress reactivity; (3) psychological factors may influence sleep quality and the severity of insomnia; (4) these important sleep-related variables may have similar associations in insomnia subgroups; they may constitute the core factors for insomnia development and maintenance. Copyright © 2015 Elsevier B.V. All rights reserved.

  10. [Safety and efficacy of docetaxel in prostate cancer patients: based on the post-marketing surveillance in Japan].

    Science.gov (United States)

    Mera, Takeshi; Saijo, Nagahiro; Akaza, Hideyuki

    2012-04-01

    The safety and efficacy of docetaxel in prostate cancer were evaluated based on the results of post-marketing surveillance. 149 patients were enrolled between September 2008 and May 2010. The starting dose of docetaxel was 75 mg/m² in 53 patients(36%), 70 mg/m² in 55 (37%), and ≤ 60 mg/m² in 41(28%). The median number of treatment cycles was 8 (range, 1 to 10). There was no age difference observed in the starting doses and the treatment cycles. The most common ≥ grade 3 adverse drug reactions (ADRs) were neutropenia (71%)and leukocytopenia (51%), and they occurred more frequently in patients receiving ≥ 70 mg/m². However, the multi-variate analyses revealed that ≥ grade 3 ADRs did not correlate with the starting doses. Infection-related events (≥ grade 3) and interstitial pneumonia were observed in 15% and 1% of patients, respectively. Prostate-specific-antigen (PSA) flare appeared in 19% of 95 evaluable patients at median period of 26 days from treatment initiation. It continued with median duration of 39. 5 days. PSA response rate as defined ≥ 50% level decline was 37%(95%confidence interval: 27-47) in evaluable patients. It was low in patients receiving ≤ 60 mg/m² (18%). There was no notable difference between patients with initial dose of 75 and 70 mg/m². Further investigation for the longer term is warranted.

  11. Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance.

    Science.gov (United States)

    Sessa, Maurizio; Rossi, Claudia; Mascolo, Annamaria; Grassi, Enrico; Fiorentino, Sonia; Scavone, Cristina; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2015-01-01

    During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014. For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions). A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions. During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.

  12. Clinical safety and efficacy of "filgrastim biosimilar 2" in Japanese patients in a post-marketing surveillance study.

    Science.gov (United States)

    Tamura, Kazuo; Hashimoto, Kazue; Nishikawa, Kiyohiro

    2018-02-02

    We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting. Copyright © 2018 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  13. Safety and efficacy of adapalene gel 0.1% in acne vulgaris: Results of a post-marketing surveillance study

    Directory of Open Access Journals (Sweden)

    Percy S

    2003-07-01

    Full Text Available Introduction: Adapalene is a novel retinoid indicated for the topical treatment of acne vulgaris. The drug was introduced in India in 2001. Aims: A post-marketing surveillance study was conducted to assess the safety and efficacy of adapalene gel 0.1% when used as monotherapy or in combination with other anti-acne agents in Indian patients of acne vulgaris. Material and Methods: A 12-week, multicentre, open-label, non-comparative study involving 571 patients from 21 centers across India was conducted between January and September of 2002. Concomitant prescription of other anti-acne drugs was permitted, if needed. Results: Of the 571 patients, 441 completed the treatment as per protocol. At the end of therapy, 96.3% of patients showed an improvement in their acne from baseline, with greater than 75% improvement seen in two-thirds of patients. Adverse events were reported in 24% of the patients, none of which were serious. The tolerability of therapy was rated as excellent/good in 81% of patients by physicians and in 78% by the patients. Conclusion: Adapalene gel 0.1% is a safe and effective topical agent in the treatment of mild to moderate acne vulgaris in Indian patients. It may be safely combined with other topical and oral anti-acne agents.

  14. Insomnia in the elderly: cause, approach, and treatment.

    Science.gov (United States)

    Kamel, Nabil S; Gammack, Julie K

    2006-06-01

    Insomnia is a prevalent problem in late life. Sleep problems in the elderly are often mistakenly considered a normal part of aging. Insomnia, the most common sleep disorder, is a subjective report of insufficient or nonrestorative sleep despite adequate opportunity to sleep. Despite the fact that more than 50% of elderly people have insomnia, it is typically undertreated, and nonpharmacologic interventions are underused by health care practitioners. This article will review the causes of insomnia in the elderly, the approach to patient evaluation, and the nonpharmacologic and pharmacologic treatment of insomnia.

  15. Insomnia Patients With Objective Short Sleep Duration Have a Blunted Response to Cognitive Behavioral Therapy for Insomnia.

    Science.gov (United States)

    Bathgate, Christina J; Edinger, Jack D; Krystal, Andrew D

    2017-01-01

    This study examined whether individuals with insomnia and objective short sleep duration insomnia (CBT-I) when compared to individuals with insomnia and normal sleep duration ≥6 h. Secondary analyses of a randomized, clinical trial with 60 adult participants (n = 31 women) from a single academic medical center. Outpatient treatment lasted 8 weeks, with a final follow-up conducted at 6 months. Mixed-effects models controlling for age, sex, CBT-I treatment group assignment, and treatment provider examined sleep parameters gathered via actigraphy, sleep diaries, and an Insomnia Symptom Questionnaire (ISQ) across the treatment and follow-up period. Six months post-CBT-I treatment, individuals with insomnia and normal sleep duration ≥6 h fared significantly better on clinical improvement milestones than did those with insomnia and short sleep duration insomnia and normal sleep duration had significantly higher insomnia remission (ISQ 80%; χ2[1, N = 60] = 21, p 50% decline in MWASO (χ2[1, N = 60] = 60, p insomnia and short sleep duration. Additionally, those with insomnia and normal sleep duration had more success decreasing their total wake time (TWT) at the 6-month follow-up compared to those with insomnia and short sleep duration (χ2[2, N = 60] = 44.1, p insomnia remission, with the area under the curve = 0.986. Findings suggest that individuals with insomnia and objective short sleep duration insomnia and normal sleep duration ≥6 h. Using an actigraphy TST cutoff of 6 hours to classify sleep duration groups was highly accurate and provided good discriminant value for determining insomnia remission. © Sleep Research Society 2016. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  16. Nighttime Insomnia Symptoms and Perceived Health in the America Insomnia Survey (AIS)

    Science.gov (United States)

    Walsh, James K.; Coulouvrat, Catherine; Hajak, Goeran; Lakoma, Matthew D.; Petukhova, Maria; Roth, Thomas; Sampson, Nancy A.; Shahly, Victoria; Shillington, Alicia; Stephenson, Judith J.; Kessler, Ronald C.

    2011-01-01

    Study Objectives: To explore the distribution of the 4 cardinal nighttime symptoms of insomnia—difficulty initiating sleep (DIS), difficulty maintaining sleep (DMS), early morning awakening (EMA), and nonrestorative sleep (NRS)—in a national sample of health plan members and the associations of these nighttime symptoms with sociodemographics, comorbidity, and perceived health. Design/Setting/Participants: Cross-sectional telephone survey of 6,791 adult respondents. Intervention: None. Measurements/Results: Current insomnia was assessed using the Brief Insomnia Questionnaire (BIQ)—a fully structured validated scale generating diagnoses of insomnia using DSM-IV-TR, ICD-10, and RDC/ICSD-2 inclusion criteria. DMS (61.0%) and EMA (52.2%) were more prevalent than DIS (37.7%) and NRS (25.2%) among respondents with insomnia. Sociodemographic correlates varied significantly across the 4 symptoms. All 4 nighttime symptoms were significantly related to a wide range of comorbid physical and mental conditions. All 4 also significantly predicted decrements in perceived health both in the total sample and among respondents with insomnia after adjusting for comorbid physical and mental conditions. Joint associations of the 4 symptoms predicting perceived health were additive and related to daytime distress/impairment. Individual-level associations were strongest for NRS. At the societal level, though, where both prevalence and strength of individual-level associations were taken into consideration, DMS had the strongest associations. Conclusions: The extent to which nighttime insomnia symptoms are stable over time requires future long-term longitudinal study. Within the context of this limitation, the results suggest that core nighttime symptoms are associated with different patterns of risk and perceived health and that symptom-based subtyping might have value. Citation: Walsh JK; Coulouvrat C; Hajak G; Lakoma MD; Petukhova M; Roth T; Sampson NA; Shahly V; Shillington A

  17. Insomnia and Its Impact on Physical and Mental Health

    Science.gov (United States)

    Fernandez-Mendoza, Julio; Vgontzas, Alexandros N.

    2014-01-01

    In contrast to the association of insomnia with mental health, its association with physical health has remained largely unexplored until recently. Based on findings that insomnia with objective short sleep duration is associated with activation of both limbs of the stress system and other indices of physiological hyperarousal, which should affect adversely physical and mental health, we have recently demonstrated that this insomnia phenotype is associated with a significant risk of cardiometabolic and neurocognitive morbidity and mortality. In contrast, insomnia with normal sleep duration is associated with sleep misperception and cognitive-emotional arousal but not with signs of physiological hyperarousal or cardiometabolic or neurocognitive morbidity. Interestingly, both insomnia phenotypes are associated with mental health, although most likely through different pathophysiological mechanisms. We propose that objective measures of sleep duration may become part of the routine evaluation and diagnosis of insomnia and that these two insomnia phenotypes may respond differentially to biological vs. psychological treatments. PMID:24189774

  18. Sequential Treatment of Comorbid Insomnia and Generalized Anxiety Disorder.

    Science.gov (United States)

    Belleville, Geneviève; Ivers, Hans; Bélanger, Lynda; Blais, France C; Morin, Charles M

    2016-09-01

    To explore the efficacy of cognitive-behavior therapy (CBT) for patients with comorbid generalized anxiety disorder (GAD) and insomnia using 2 sequential treatments. Using a single-case methodology, 10 women (mean age = 45) with chronic insomnia and GAD were randomly assigned to CBT for GAD followed by CBT for insomnia, or to CBT for insomnia followed by CBT for GAD. Sleep and anxiety were measured via diagnostic interviews, daily diaries, and self-report questionnaires. Time series analyses, group effect sizes, and indications of clinically significant change revealed improvements on anxiety, worry, and sleep after CBT for GAD. Following CBT for insomnia, positive changes were observed on sleep and, to a lesser extent, anxiety and worry. In the presence of comorbid GAD and insomnia, initiating treatment for GAD first produced superior clinical benefits in anxiety and sleep. The addition of insomnia-specific treatment led to additional improvements in worry and sleep quality. © 2016 Wiley Periodicals, Inc.

  19. Treatment Options for Insomnia | Ramakrishnan | South African ...

    African Journals Online (AJOL)

    Exercise improves sleep as effectively as benzodiazepines in some studies and, given its other health benefits, is recommended for patients with insomnia. Hypnotics generally should be prescribed for short periods only, with the frequency and duration of use customized to each patient\\'s circumstances. Routine use of ...

  20. [Insomnia. A severe health care problem].

    Science.gov (United States)

    Sánchez-Cárdenas, Ana Gabriela; Navarro-Gerrard, Christian; Nellen-Hummel, Haiko; Halabe-Cherem, José

    2016-01-01

    The magnitude which sleep has on personal well-being is similar to the effects of diet and exercise. Sleep deprivation has severe negative effects on an individual's overall health, and this is usually overseen. From 30 to 40 % of the population has presented insomnia at a certain moment of life and from 9 to 15 % have evolved into a chronic and severe insomnia. Recent investigations have related sleep deprivation with obesity, metabolic disorders, heart disease, mental health problems and dementia. Recently, more investigations have focused on the multiple alterations suffered by the immune system in cases of sleep deprivation. In order to make an opportune diagnosis of insomnia, it is vital to obtain a detailed history of the patients' sleep habits. In the physical exam one must search for signs and symptoms which might suggest an organic cause that generates the patient's insomnia. One of the pillars in treatment of these patients consists in acquiring an adequate sleep hygiene based on the optimization of the environment and the behavior that are associated with sleep.

  1. Levofloxacin-induced acute anxiety and insomnia

    Directory of Open Access Journals (Sweden)

    Arun Kandasamy

    2012-01-01

    Full Text Available Fluoroquinolones can cause adverse neuropsychiatric side effects, which are more common in older age. We present three cases of levofloxacin-induced acute anxiety and insomnia in young adults. In all the cases, discontinuation of levofloxacin immediately lead to remission.

  2. The burden of insomnia in Japan

    Directory of Open Access Journals (Sweden)

    Mishima K

    2015-01-01

    Full Text Available Kazuo Mishima,1 Marco daCosta DiBonaventura,2 Hillary Gross2 1Department of Psychophysiology, National Institute of Mental Health, National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan; 2Kantar Health, New York, NY, USA Objectives: Several studies have suggested that patients who experience insomnia report a number of significant impairments. However, despite this literature, fewer studies have focused on the burden of insomnia among patients in Japan. The objective of the current study is to extend this work in Japan to further understand the effect of insomnia on health-related quality of life (hrQOL. Further, another objective is to understand general predictors of hrQOL among patients with insomnia. Methods: Data from the 2012 Japan National Health and Wellness Survey, an annual, cross-sectional study of adults aged 18 years or older, were used (N=30,000. All National Health and Wellness Survey respondents were categorized based on the incidence of self-reported insomnia diagnosis and prescription medication usage (clinical insomniacs under treatment versus [vs] good sleepers without insomnia or insomnia symptoms. Comparisons among different groups were made using multiple regression models controlling for demographics and health history. Results: Clinical insomniacs (n=1,018; 3.4% reported significantly worse hrQOL compared with good sleepers (n=20,542 (mental component summary: 34.2 vs 48.0; physical component summary: 48.0 vs 52.8; health utilities: 0.61 vs 0.76; all P<0.05. Health behaviors (smoking, exercise, alcohol use and comorbidities were the strongest predictors of health utilities for clinical insomniacs. For all three clinical insomniac subgroups of interest, those with a physical comorbidity but not a psychiatric one, those with a psychiatric comorbidity but not a physical one, and those without either a physical or psychiatric comorbidity, large decrements in health utilities were observed for respondents who did

  3. Ezetimibe, and the combination of ezetimibe/simvastatin, and risk of cancer: A post-marketing analysis.

    Science.gov (United States)

    Alsheikh-Ali, Alawi A; Karas, Richard H

    2009-04-01

    In the recently reported Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, the combination of ezetimibe/simvastatin (E/S) was associated with a significantly increased risk of cancer compared to placebo, causing widespread public concern. We examined the rates of cancer adverse event reports filed with the US Food and Drug Administration (FDA) of patients on ezetimibe or E/S, and compared these to reports with other potent cholesterol-lowering drugs. We tabulated all adverse event reports listing "cancer" or "malignancy" filed with the FDA (July 2004 to March 2008) of patients taking ezetimibe or E/S, and compared those to reports of patients taking simvastatin, atorvastatin, or rosuvastatin. We calculated rates for such reports per million prescriptions. A secondary analysis examined cancer reports as a proportion of all reported adverse events for each medication. Prescriptions for all drugs totaled 559 million (approximately 52 and 55 million prescriptions of ezetimibe and E/S, respectively), and cancer adverse event reports totaled 2334. There were 2.9 and 1.3 cancer-associated adverse event reports per million ezetimibe or E/S prescriptions, respectively, compared to a range of 3.1 to 5.1 per million prescriptions for the other drugs. Findings were similar when only reports listing the drug as "suspect" were considered. The proportions of reports listing cancer relative to all adverse event reports were 2.0% and 1.9% for ezetimibe and E/S, respectively, compared to a range of 1.3% to 3.9% for the other drugs. This large-scale post-marketing analysis of reported adverse events does not support that ezetimibe or E/S increase the risk of cancer.

  4. Safety and Effectiveness of Natalizumab: First Report of Interim Results of Post-Marketing Surveillance in Japan.

    Science.gov (United States)

    Saida, Takahiko; Yokoyama, Kazumasa; Sato, Ryusuke; Makioka, Haruki; Iizuka, Yukihiko; Hase, Masakazu; Ling, Yan; Torii, Shinichi

    2017-12-01

    Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan. Here, we report the results of an interim analysis. During the observation period of 2 years, all patients who were treated with natalizumab subsequent to its approval in Japan were followed. The effectiveness of natalizumab was assessed by examining the changes in expanded disability status scale (EDSS) score and annualized relapse rate (ARR) from baseline. Safety was assessed by analyzing the incidence of adverse drug reactions (ADRs). The safety analysis included 106 patients (mean age 39.3 years; women 62.3%) whose data were collected until the data lock point (February 7, 2016). The effectiveness analysis included 75 patients. The majority of patients had relapsing-remitting MS (93/106 patients; 87.7%). The mean length of treatment exposure in the present study was 6.6 months. During the 2-year observation period, no significant change in the EDSS was observed, while the ARR decreased significantly from baseline (72.9% reduction, p = 0.001). ADRs and serious ADRs were observed in 11.3% and 3.8% of patients, respectively; however, no new safety concerns were detected. No patient had progressive multifocal leukoencephalopathy (PML) during the present study period. The safety and effectiveness of natalizumab were confirmed in Japanese patients with MS in clinical practice. Nevertheless, potential risks including PML require continuous, careful observation. Biogen Japan Ltd (Tokyo, Japan).

  5. The clinical efficacy of a clarithromycin-based regimen for Mycobacterium avium complex disease: A nationwide post-marketing study.

    Science.gov (United States)

    Kadota, Jun-Ichi; Kurashima, Atsuyuki; Suzuki, Katsuhiro

    2017-05-01

    The revised 2007 American Thoracic Society/Infectious Diseases Society of America statement recommend clarithromycin-based combination therapy for treatment of Mycobacterium avium complex lung disease and stipulates approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient. Our objective was to obtain data on the clinical outcome of clarithromycin-based daily regimens by conducting a nationwide retrospective post-marketing study of M. avium complex lung disease. In accordance with the Japanese guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multidrug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin-based regimen) until bacilli negative conversion, and the treatment was continued for approximately 1 year after the initial conversion. Data were collected before administration, at the time of bacilli negative conversion, at the end of treatment, and at 6 months after the end of treatment. Of the 466 subjects enrolled in the study, 271 patients who received clarithromycin at 800 mg/day underwent evaluation for M. avium complex disease. The final bacilli negative conversion rate in those patients was 94.7%. The bacteriological relapse rate was 5.0% (5/100 patients). Bacteriological relapse was noted in patients treated for less than 15 months after conversion. No life-threatening or serious adverse drug reactions were observed. This study demonstrated that a clarithromycin-based daily regimen can yield a high bacteriological conversion rate in M. avium complex disease. After conversion, treatment for less than 15 months might be insufficient to prevent bacteriological relapse. Copyright © 2017 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  6. Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data.

    Science.gov (United States)

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Murakami, Masahiro

    2017-05-01

    To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography. Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement. This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

  7. Drug-induced lung injury associated with sorafenib: analysis of all-patient post-marketing surveillance in Japan.

    Science.gov (United States)

    Horiuchi-Yamamoto, Yuka; Gemma, Akihiko; Taniguchi, Hiroyuki; Inoue, Yoshikazu; Sakai, Fumikazu; Johkoh, Takeshi; Fujimoto, Kiminori; Kudoh, Shoji

    2013-08-01

    Sorafenib is a multi-kinase inhibitor currently approved in Japan for unresectable and/or metastatic renal cell carcinoma and unresectable hepatocellular carcinoma. Although drug-induced lung injury has recently been the focus of interest in Japanese patients treated with molecular targeting agents, the clinical features of patients receiving sorafenib remain to be completely investigated. All-patient post-marketing surveillance data was obtained within the frame of Special Drug Use Investigation; between April 2008 and March 2011, we summarized the clinical information of 62 cases with drug-induced lung injury among approximately 13,600 sorafenib-treated patients in Japan. In addition, we summarized the results of evaluation by a safety board of Japanese experts in 34 patients in whom pulmonary images were available. For the calculation of reporting frequency, interim results of Special Drug Use Investigation were used. In the sets of completed reports (2,407 in renal cell carcinoma and 647 in hepatocellular carcinoma), the reporting frequency was 0.33 % (8 patients; fatal, 4/8) and 0.62 % (4 patients; fatal, 2/4), respectively. Major clinical symptoms included dyspnea, cough, and fever. Evaluation of the images showed that 18 cases out of 34 patients had a pattern of diffuse alveolar damage. The patients with hepatocellular carcinoma showed a greater incidence and earlier onset of lung injury than those with renal cell carcinoma. Although the overall reporting frequency of sorafenib-induced lung injury is not considered high, the radiological diffuse alveolar damage pattern led to a fatal outcome. Therefore, early recognition of sorafenib-induced lung injury is crucial for physicians and patients.

  8. Clinical significance and epidemiologic analyses of Mycobacterium avium and Mycobacterium intracellulare lung disease from post-marketing surveillance.

    Science.gov (United States)

    Suzuki, Katsuhiro; Kurashima, Atsuyuki; Tatsuno, Kinji; Kadota, Jun-Ichi

    2018-01-01

    In Japan, nontuberculous mycobacterial lung disease is mostly attributable to Mycobacterium avium complex (MAC), i.e., M. avium or M. intracellulare. However, clinical features of the disease caused by these two pathogens have not been studied sufficiently yet. A post-marketing survey of clarithromycin was performed at 130 facilities across Japan. The data on patients with M. avium infection and patients with M. intracellulare infection were selected from this survey for comparison of background variables and clinical features of the two pathogens. Among the patients analyzed (n = 368), 67.4% had M. avium infection and 32.6% had M. intracellulare infection. Stratified analysis revealed no significant differences between the ratio of the two pathogens based on gender, disease type, complication, past medical history, or smoking history. However, the percentage of patients with M. intracellulare infection was significantly higher among those with underlying lung disease than among those without lung disease (p = 0.0217). The percentage of patients with M. intracellulare infection rose significantly with age (p = 0.0296). This age-related change was more significant in women (p = 0.0018). When district-wise analysis was performed for Japan, the percentage of M. intracellulare infection was higher in the Chugoku/Shikoku and Kyushu districts whereas the percentage of M. avium infection was higher in the other districts. This survey revealed some differences in the clinical and epidemiologic features of M. avium and M. intracellulare infection. The significant predominance of M. avium infection among relatively young women is suggestive of an increase in the M. avium/M. intracellulare infection ratio among women in the future. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  9. Characteristics of adverse drug reactions in a vemurafenib early post-marketing phase vigilance study in Japan.

    Science.gov (United States)

    Uhara, H; Kiyohara, Y; Tsuda, A; Takata, M; Yamazaki, N

    2018-02-01

    Post-approval research or monitoring is important to determine real-world safety of new products; however, evidence is scant for vemurafenib in Japanese patients. In Japan, a unique system is officially obligated to investigate post-approval safety. Here we report the first adverse drug reaction (ADR) data from vemurafenib-treated Japanese patients with metastatic melanoma. Data were collected in an early post-marketing phase vigilance (EPPV) study. ADRs were events for which a causal relationship with vemurafenib could not be ruled out or was unknown. ADR data were collected for patients treated with vemurafenib (960 mg bid) between 26 February and 25 August 2015. Among 95 patients, 46 patients had 118 ADRs (24 serious ADRs in 13 patients). The most common serious ADRs were hypersensitivity (n = 1; 3 events), arthralgia (n = 2; 2 events), pyrexia (n = 2; 2 events) and drug eruption (n = 2; 2 events). Seven patients had serious skin disorders or hypersensitivity, six of whom had prior anti-programmed cell death-1 (PD-1) antibodies 5-35 days before starting vemurafenib. ADR reports of serious skin disorders appeared to be collected more rapidly than previously reported. Cutaneous squamous cell carcinoma developed in only one patient. EPPV in Japanese vemurafenib-treated patients identified no new safety signals. The most serious skin and hypersensitivity ADRs occurred in patients with prior anti-PD-1 exposure. Cutaneous squamous cell carcinoma appeared to be rare in Japanese patients. Further research is needed to clarify whether prior treatment with anti-PD-1 agents or racial differences affect the characteristic profile of cutaneous ADRs in Japanese patients.

  10. Transitioning from first- to second-generation biosimilars: An appraisal of regulatory and post-marketing challenges.

    Science.gov (United States)

    Blandizzi, Corrado; Galeazzi, Mauro; Valesini, Guido

    2018-02-01

    Second-generation biosimilars (i.e. monoclonal antibodies or proteins generated by fusion of antibody and receptor moieties) differ in several respects as compared to first-generation ones (e.g. epoetins, bone marrow stimulating factors, somatotropins). In this respect, as second-generation biosimilars are endowed with much greater structural and molecular complexity, which might translate into a number of pharmacological and therapeutic issues, they raise new challenges for manufacturers and regulatory authorities as well as new concerns for clinicians. Based on these arguments, the present article was intended to review information on the main differences between first- and second-generation biosimilars for treatment of immune-mediated inflammatory diseases, as well as their impact on immunogenicity, the design of clinical trials and the critical issue of extrapolation of therapeutic indications. The positions taken by relevant medical associations and the crucial role of pharmacovigilance are also reviewed. According to current knowledge, the initial post-marketing clinical experience with second-generation biosimilars is providing encouraging results, though their long-term safety and efficacy as well as the scientific basis underlying the extrapolation of therapeutic indications are still matter of discussion. There is some consensus that marketing applications should rely on studies supporting the clinical use of biosimilars in their different target diseases and patient populations. In parallel, clinical safety must be ensured by a strict control of the manufacturing processes and a solid pharmacovigilance program. It remains then a responsibility of the physician to drive a proper use of second-generation biosimilars into clinical practice, in accordance with guidelines issued by scientific societies. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review.

    Science.gov (United States)

    Polisena, Julie; Forster, Alan J; Cimon, Karen; Rabb, Danielle

    2013-10-10

    Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.

  12. Post-marketing access to orphan drugs: a critical analysis of health technology assessment and reimbursement decision-making considerations

    Directory of Open Access Journals (Sweden)

    Iskrov G

    2014-01-01

    Full Text Available Georgi Iskrov, Rumen Stefanov Department of Social Medicine and Public Health, Medical University of Plovdiv, Plovdiv, Bulgaria Abstract: This study aims to explore the current rationale of post-marketing access to orphan drugs. As access to orphan medicinal products depends on assessment and appraisal by health authorities, this article is focused on health technology assessment (HTA and reimbursement decision-making considerations for orphan drugs. A critical analysis may identify important factors that could predetermine the combined outcomes of these two processes. Following this objective, an analytical framework was developed, comprising three overlaying issues: to outline what is currently done and what needs to be done in the field of HTA of orphan drugs, to synthesize important variables relevant to the reimbursement decision-making about orphan drugs, and to unveil relationships between theory and practice. Methods for economic evaluation, cost-effectiveness threshold, budget impact, uncertainty of evidence, criteria in reimbursement decision-making, and HTA research agenda are all explored and discussed from an orphan drug perspective. Reimbursement decision-making for orphan drugs is a debate of policy priorities, health system specifics, and societal attitudes. Health authorities need to pursue a multidisciplinary analysis on a range of criteria, ensuring an explicit understanding of the trade-offs for decisions related to eligibility for reimbursement. The only reasonable way to accept a higher valuation of orphan drug benefits is if these are demonstrated empirically. Rarity means that the quality of orphan drug evidence is not the same as for conventional therapies. Closing this gap is another crucial point for the timely access to these products. The generation of evidence goes far beyond pre-market authorization trials and requires transnational cooperation and coordination. Early constructive dialogue among orphan drug

  13. Insomnia in people with epilepsy: A review of insomnia prevalence, risk factors and associations with epilepsy-related factors.

    Science.gov (United States)

    Macêdo, Philippe Joaquim Oliveira Menezes; Oliveira, Pedro Sudbrack de; Foldvary-Schaefer, Nancy; Gomes, Marleide da Mota

    2017-09-01

    Insomnia is a common sleep complaint in the general population, and sleep loss may be a trigger for epileptic seizures. To conduct a comprehensive review of the literature of insomnia symptoms and insomnia disorder, their prevalence and epilepsy-related risk factors in people with epilepsy (PWE). A PUBMED search was performed for articles indexed to June 2016 involving human subjects, excluding papers in languages other than English, Spanish and Portuguese and case reports. Eligible studies were those using a clear definition of insomnia and reporting quantitative data on prevalence rates and risk factors. The search included the following terms: insomnia, sleep disorder(s), sleep disturbance(s) and sleep-wake in the title and abstract; and epilep* in the title. 425 papers were reviewed and 31 were selected for the final analysis (21 adult and 10 paediatric). Twenty-one studies used a control group. Two reviewer authors independently extracted all data and a third author resolved disagreements. Most studies were hospital-based, cross-sectional and evaluated convenience samples representing highly select populations. Various insomnia inventories were used. Fourteen assessed insomnia (10 in adults, four, children), but only five as primary outcome (none in children). Four evaluated insomnia disorder based on international classification criteria (International Classification of Sleep Disorders - ICSD-2-in 3, and DSM-IV-TR, in 1). In adults, insomnia prevalence was 28.9-51% based on the Insomnia Severity Index ≥15 and 36-74.4% based on DSM-IV-TR or ICSD-2. The prevalence of insomnia in children was 13.1-31.5% using the Sleep Disturbance Scale for Children and 11% based on ICSD-2 diagnostic criteria. Compared to control groups, PWE usually had higher frequencies of insomnia symptoms and disorder. Insomnia was associated with greater impairment in quality of life and higher degree of depressive symptoms in several studies, and was inconsistently related to female

  14. [Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

    Science.gov (United States)

    Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

    2011-10-01

    Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

  15. Psychosocial correlates of insomnia severity in primary care.

    Science.gov (United States)

    Bluestein, Daniel; Rutledge, Carolyn M; Healey, Amanda C

    2010-01-01

    Insomnia is a substantive primary care issue that leads to adverse outcomes. These can be improved by addressing factors that accentuate insomnia severity. Accordingly, this study identifies correlates of insomnia severity and determines whether these relationships vary with sociodemographic attributes. This correlational cross-sectional study was conducted in a hospital-sponsored primary care clinic and 2 urban, academic family practice centers. Participants consisted of 236 patients 18 years old or older with clinically significant insomnia (Insomnia Severity Index scores of 7 or more). Surveys instruments included the Insomnia Severity Index, SF-8 (Medical Outcomes Study SF-8 global health status measure), CES-D (Center for Epidemiologic Studies-Depression Scale), DBAS (Dysfunctional Beliefs about Sleep scale), SE-S (Self-Efficacy for Sleep Scale), and a researcher-designed demographic survey. Analytic techniques included descriptive statistics to characterize the study sample, Pearson or Spearman Correlation Coefficients to examine individual associations with insomnia severity, and step-wise linear regression to identify net predictors. Insomnia severity was significantly correlated with health status, depression, self-efficacy, and dysfunctional beliefs (P insomnia severity was best predicted by low self-efficacy and high depression scores. These findings indicate that clinicians treating insomnia should not only manage comorbid depression but also facilitate self-efficacy for sleep-inducing behavioral change.

  16. Case Studies of Chronic Insomnia Patients Participating in Group Cognitive Behavioral Therapy for Insomnia

    Directory of Open Access Journals (Sweden)

    Mi Jin Yi

    2012-10-01

    Full Text Available Background and Objective Pharmacotherapy currently widely used in the treatment of insomnia can be helpful in transient insomnia, but research regarding its effectiveness and safety of long-term use is not enough. Therefore, to complement the limitations of pharmacotherapy in the treatment of patients with insomnia, non-pharmacologic treatment methods (cognitive behavioral therapy, CBT are used. But CBT for insomnia appear to be costly and time-consuming compared to pharmacotherapy, clinical practice in the field can be difficult to be applied. We took the format of group therapy rather than individual therapy to complement the disadvantages of CBT and now we would like to have a thought into its meaning by reporting the effectiveness of group CBT for insomnia. Methods Patients were recruited at Sleep Center of St. Vincent’s Hospital, 2 men and 3 women led to a group of five patients. CBT is a treatment for correction factors that cause and maintain insomnia, it includes a variety of techniques such as sleep hygiene education, stimulus control, sleep restriction, relaxation and cognitive therapy. A series of treatment were performed five sessions once a week with a frequency from February to March 2012 and were proceeded for about 1 hour and 30 minutes per session. Results Results indicated that the subjective quality of sleep and sleep efficiency of all patients improved and Pittsburgh Sleep Quality Index and Beck Depression Inventory were decreased in spite of reducing dose of medication. Conclusions Like these cases, we can contribute to reduce the time and economic burden by performing group CBT for insomnia rather than individual therapy.

  17. Examining maladaptive beliefs about sleep across insomnia patient groups.

    Science.gov (United States)

    Carney, Colleen E; Edinger, Jack D; Morin, Charles M; Manber, Rachel; Rybarczyk, Bruce; Stepanski, Edward J; Wright, Helen; Lack, Leon

    2010-01-01

    Unhelpful beliefs about sleep have been linked to insomnia, and increasing one's cognitive flexibility about sleep has been linked to posttreatment sleep improvement. This study evaluated whether levels of such beliefs differ across insomnia groups and whether there are particular beliefs that differ for specific insomnia subtypes. Participants (N=1384) were people with insomnia and good sleepers ranging from 18 to 89 years old (mean=42.6; S.D.=19.4). Data from previous studies at five insomnia clinical sites were pooled to examine responses on the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) across differing insomnia groups. Group analyses revealed that those from community-based insomnia clinics and those who are hypnotic-dependent generally had the highest levels of unhelpful sleep-related beliefs. With the exception of beliefs about sleep needs (wherein only community sleep clinic patients had high scores relative to good sleepers), all insomnia groups had higher scores on the 16-item DBAS (DBAS-16) than good sleepers. A validity analysis suggested that a DBAS-16 index score of >3.8 represented the level of unhelpful beliefs associated with clinically significant insomnia, although a slightly lower cutoff may be useful for identifying an unhelpful degree of sleep-related beliefs in highly screened primary-insomnia-only and medical patient groups. This study offers descriptive data for the use of DBAS-16 across insomnia subgroups, which will help the user understand what degree of maladaptive sleep beliefs is most strongly associated with clinically significant levels of insomnia. Results also may have implications for cognitive targeting during treatment for particular insomnia groups.

  18. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China.

    Science.gov (United States)

    Guo, Biao; Page, Andrew; Wang, Huaqing; Taylor, Richard; McIntyre, Peter

    2013-01-11

    China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse. To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally. Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages. Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3-37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria-tetanus-pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3-181.1/100,000 doses for DTwP; range 3.5-92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world. Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. Post-marketing surveillance on the long-term use of dabigatran in Japanese patients with nonvalvular atrial fibrillation: Preliminary report of the J-dabigatran surveillance

    OpenAIRE

    Inoue, Hiroshi; Uchiyama, Shinichiro; Atarashi, Hirotsugu; Okumura, Ken; Koretsune, Yukihiro; Yasaka, Masahiro; Yamashita, Takeshi; Ohnishi, Makiko; Yagi, Nobutaka; Fukaya, Taku

    2016-01-01

    Background/aim: A post-marketing surveillance (PMS) study is being conducted to investigate the safety and effectiveness of the long-term use of dabigatran etexilate (dabigatran) in Japanese patients with nonvalvular atrial fibrillation (NVAF). Results of an interim analysis of this prospective cohort study including patient characteristics and adverse drug reactions (ADRs) collected up to September 17, 2014 are reported here. Methods: Patients with NVAF who began to receive dabigatran for...

  20. Somatic syndromes, insomnia, anxiety, and stress among sleep disordered breathing patients.

    Science.gov (United States)

    Amdo, Tshering; Hasaneen, Nadia; Gold, Morris S; Gold, Avram R

    2016-05-01

    We tested the hypothesis that the prevalence of somatic syndromes, anxiety, and insomnia among sleep disordered breathing (SDB) patients is correlated with their levels of somatic arousal, the symptoms of increased sympathetic nervous system tone under conditions of stress. We administered the Body Sensation Questionnaire (BSQ; a 17-item questionnaire with increasing levels of somatic arousal scored 17-85) to 152 consecutive upper airway resistance syndrome (UARS) patients and 150 consecutive obstructive sleep apnea/hypopnea (OSA/H) patients. From medical records, we characterized each patient in terms of the presence of syndromes and symptoms into three categories: somatic syndromes (six syndromes), anxiety (anxiety disorders, nightmares, use of benzodiazepines), and insomnia (sleep onset, sleep maintenance, and use of hypnotics). For the pooled sample of SDB patients, we modeled the correlation of the BSQ score with the presence of each syndrome/symptom parameter within each of the three categories, with adjustment for male vs. female. Mean BSQ scores in females were significantly higher than those in males (32.5 ± 11.1 vs. 26.9 ± 8.2; mean ± SD). Increasing BSQ scores significantly correlated with increasing prevalence rates of somatic syndromes (p insomnia (p ≤ 0.0001). In general, females had higher prevalence rates of somatic syndromes and symptoms of anxiety than males at any BSQ score while rates of insomnia were similar. In patients with SDB, there is a strong association between the level of somatic arousal and the presence of stress-related disorders like somatic syndromes, anxiety, and insomnia.

  1. Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch®capsules 2.5 μg) in 3,762 hemodialysis patients with intractable pruritus.

    Science.gov (United States)

    Kozono, Hideki; Yoshitani, Hiroshi; Nakano, Ryoko

    2018-01-01

    Intractable pruritus in hemodialysis patients can significantly decrease their quality of life and is also associated with poor vital prognosis. Although combined multiple causes of intractable pruritus in these patients have been identified, no existing treatments are proven to be sufficiently effective. We conducted a post-marketing surveillance to follow-up and assess the safety and efficacy of nalfurafine, a selective κ-opioid receptor agonist, for the treatment of intractable pruritus in patients undergoing hemodialysis. Hemodialysis patients with intractable pruritus from institutions in Japan who received oral nalfurafine hydrochloride between January 2010 and December 2013 were enrolled in the surveillance. Surveillance was completed in July 2015. Safety data during 1 year after nalfurafine treatment onset, and efficacy data of nalfurafine evaluating the first 12-week treatment period and the following period until 1 year after the initial dose of nalfurafine (using global assessment of the itch improvement by the physician, Visual Analog Scale, and the Shiratori's severity scores) were collected and analyzed. In total, 3,762 patients were analyzed for safety. Adverse drug reactions were experienced by 402/3,762 (10.69%) patients. The most frequent adverse drug reactions were insomnia (127/3,762 [3.38%] patients), constipation (34 [0.90%]), somnolence (32 [0.85%]), dizziness (23 [0.61%]), nausea (13 [0.35%]), and malaise (9 [0.24%]). No patients developed dependence on nalfurafine. Nalfurafine was effective in 82.50% (2,880/3,491) of patients during the first 12 weeks and in 84.95% (2,167/2,551) on treatment during the subsequent period until 1 year after nalfurafine treatment initiation. Statistically significant decreases were reported in the Visual Analog Scale and the Shiratori's severity scores ( p <0.001). Oral nalfurafine hydrochloride (from 2.5 μg/day to a maximum of 5.0 μg/day) continues to be safe and effective for the treatment of intractable

  2. Sleep-related cognitive processes, arousal, and emotion dysregulation in insomnia disorder: the role of insomnia-specific rumination.

    Science.gov (United States)

    Palagini, Laura; Moretto, Umberto; Dell'Osso, Liliana; Carney, Colleen

    2017-02-01

    Insomnia-specific rumination has presented in subjects with insomnia. Research has identified hyperarousal as a key factor, with both trait and state components. It has been shown that emotion dysregulation also plays a role in insomnia. Hence, the aim was to investigate how insomnia rumination is associated with both trait- and state-dependent arousal and emotion dysregulation in insomnia. Sixty-eight subjects with insomnia disorder (DSM-5) and 36 good sleepers were evaluated using: Insomnia Severity Index (ISI), Daytime Insomnia Symptom Response Scale (DISRS), Arousal Predisposition Scale (APS), Pre-sleep Arousal Scale (PSAS), and Difficulties in Emotion Regulation Scale (DERS). Univariate and multivariate regression analyses and mediation analyses were performed. Subjects with insomnia (F 41, mean age 50.2 ± 10) presented higher scores than good sleepers (F 22, mean age 49.7 ± 14) in all the scales (ISI, DISRS, APS, PSAS, DERS; p cognitive B = 0.22, p cognitive and somatic arousal (p = 0.02), and the association between trait hyperarousal and emotion dysregulation (Z = 2.3, p = 0.04). In insomnia, specific rumination is related to both trait predisposition to arousal and to state-dependent arousal. It is also related to emotion dyregulation. Insomnia-specific ruminative response style may modulate the complex association between trait- and state-dependent arousal factors and arousal and emotion regulation in insomnia. In this framework, a broad range of cognitive processes may be considered when dealing with subjects with insomnia: the use of rumination-oriented psychological strategies could be important. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. [Insomnia and lifestyle-related diseases].

    Science.gov (United States)

    Uchimura, Naohisa

    2012-07-01

    As both insomnia and lifestyle-related diseases are associated with a variety of underlying factors, they have been considered to occur as a complication of each other. Moreover, evidence has been presented in recent studies that they are closely related to each other as risks of development and exacerbation. As unhealthy lifestyle-habits have long been recognized to increase the risks of lifestyle-related diseases and their worsening, it is natural that sleep, which takes up one third of a person's life, is markedly associated with disorders such as hypertension and diabetes. It is important to provide interventions for insomnia and other sleep disorders based on the same viewpoint as for lifestyle-related diseases, and understand that lifestyle advice, including sleep hygiene, and drug treatment with sleeping pills are also effective for the treatment of lifestyle-related diseases themselves.

  4. Delays in the post-marketing withdrawal of drugs to which deaths have been attributed: a systematic investigation and analysis.

    Science.gov (United States)

    Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

    2015-02-05

    Post-marketing withdrawal of medicinal products because of deaths can be occasioned by evidence obtained from case reports, observational studies, randomized trials, or systematic reviews. There have been no studies of the pattern of withdrawals of medicinal products to which deaths have been specifically attributed and the evidence that affects such decisions. Our objectives were to identify medicinal products that were withdrawn after marketing in association with deaths, to search for the evidence on which withdrawal decisions were based, and to analyse the delays involved and the worldwide patterns of withdrawal. We searched the World Health Organization's Consolidated List of [Medicinal] Products, drug regulatory authorities' websites, PubMed, Google Scholar, and textbooks on adverse drug reactions. We included medicinal products for which death was specifically mentioned as a reason for withdrawal from the market. Non-human medicines, herbal products, and non-prescription medicines were excluded. One reviewer extracted the data and a second reviewer verified them independently. We found 95 drugs for which death was documented as a reason for withdrawal between 1950 and 2013. All were withdrawn in at least one country, but at least 16 remained on the market in some countries. Withdrawals were more common in European countries; few were recorded in Africa (5.3%). The more recent the launch date, the sooner deaths were reported. However, in 47% of cases more than 2 years elapsed between the first report of a death and withdrawal of the drug, and the interval between the first report of a death attributed to a medicinal product and eventual withdrawal of the product has not improved over the last 60 years. These results suggest that some deaths associated with these products could have been avoided. Manufacturers and regulatory authorities should expedite investigations when deaths are reported as suspected adverse drug reactions and consider early suspensions

  5. Tackling sleeplessness: Psychological treatment options for insomnia

    Directory of Open Access Journals (Sweden)

    Natalie D Dautovich

    2010-03-01

    Full Text Available Natalie D Dautovich1, Joseph McNamara2, Jacob M Williams3, Natalie J Cross4, Christina S McCrae31Department of Psychology, 2Department of Psychiatry, 3Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA; 4Department of Veterans Affairs Community Based Outpatient Clinic, Greenville, NC, USAAbstract: The purpose of the present paper is to review and summarize the research supporting nonpharmacologic treatment options for insomnia. The different treatment approaches are described followed by a review of both original research articles and meta-analyses. Meta-analytic reviews suggest that common nonpharmacologic approaches exert, on average, medium to large effect sizes on SOL, WASO, NWAK, SQR, and SE while smaller effects are seen for TST. Stimulus control therapy, relaxation training, and CBT-I are considered standard treatments for insomnia by the American Academy of Sleep Medicine (AASM. Sleep restriction, multicomponent therapy without cognitive therapy, paradoxical intention, and biofeedback approaches have received some levels of support by the AASM. Sleep hygiene, imagery training, and cognitive therapy did not receive recommendation levels as single (standalone therapies by the AASM due to lack of empirical evidence. Less common approaches have been introduced (Internet-based interventions, bright light treatment, biofeedback, mindfulness, acupuncture, and intensive sleep retraining but require further research. Brief and group treatments have been shown to be as efficacious as longer and individually-administered treatments. Considerations are presented for special populations, including older adults, children and teens, individuals from diverse cultural backgrounds, insomnia comorbid with other disorders, and individuals who are taking hypnotics.Keywords: insomnia, nonpharmacologic, psychological, behavioral, treatments, sleep

  6. Indiplon in the management of insomnia

    Directory of Open Access Journals (Sweden)

    Michael D Lemon

    2009-05-01

    Full Text Available Michael D Lemon1, Joe D Strain2, Annie M Hegg1, Debra K Farver3 1Department of Pharmacy Practice, South Dakota State University College of Pharmacy, VA Black Hills Health Care System, Fort Meade, SD, USA; 2Department of Pharmacy Practice, South Dakota State University College of  Pharmacy, Rapid City Regional Hospital, Rapid City, SD, USA; 3Department of Pharmacy Practice, South Dakota State University College of Pharmacy, South Dakota Human Services Center, Yankton, SD, USAAbstract: Indiplon is a novel pyrazolopyrimidine, nonbenzodiazepine γ-aminobutyric acid (GABA agonist studied for the treatment of insomnia. This article reviews the chemistry, pharmacology, clinical pharmacokinetics, drug interactions, clinical trials, safety, tolerability, contraindications, use in special populations, and dosing of indiplon. OVID, International Pharmaceutical Abstracts (IPA, and PubMed databases were searched (1966 to February 2009 for the keywords indiplon, NBI-34060, and insomnia. References of key articles were also reviewed to identify additional publications. Only English language articles were selected for review. Indiplon has been shown to have high affinity and selectivity for the GABAα1 receptor subunit associated with sedation. In clinical studies, indiplon has demonstrated efficacy in improving latency to sleep onset, latency to persistent sleep, total sleep time, wake time after sleep onset, number of awakenings after sleep onset, and overall sleep quality when compared to placebo. Indiplon has a favorable safety profile with limited rebound insomnia and no tolerance. Neurocrine Biosciences, Incorporated received an Approvable Letter from the United States Food and Drug Administration in December 2007 for the indiplon IR 5 mg and 10 mg capsules based on meeting three additional requirements. At the time of this writing, indiplon remains unapproved.Keywords: indiplon, insomnia, NBI-34060

  7. European guideline for the diagnosis and treatment of insomnia

    OpenAIRE

    Riemann, Dieter; Baglioni, Chiara; Bassetti, Claudio; Bjorvatn, Bjorn; Groselj, Leja Dolenc; Ellis, Jason G.; Espie, Colin A.; Garcia-Borreguero, Diego; Gjerstad, Michaela; Goncalves, Marta; Hertenstein, Elisabeth; Jansson-Frojmark, Markus; Jennum, Poul J.; Leger, Damien; Nissen, Christoph

    2017-01-01

    Abstract: This European guideline for the diagnosis and treatment of insomnia was developed by a task force of the European Sleep Research Society, with the aim of providing clinical recommendations for the management of adult patients with insomnia. The guideline is based on a systematic review of relevant meta-analyses published till June 2016. The target audience for this guideline includes all clinicians involved in the management of insomnia, and the target patient population includes ad...

  8. Insomnia in chronic renal patients on dialysis in Saudi Arabia

    OpenAIRE

    Al-Jahdali, Hamdan H; Khogeer, Haithm A; Al-Qadhi, Waleed A; Baharoon, Salim; Tamim, Hani; Al-Hejaili, Fayez F; Al-Ghamdi, Saeed M; Al-Sayyari, Abdullah A

    2010-01-01

    Abstract Background Studies have shown that insomnia is a common sleep disorder among patients with end-stage renal disease (ESRD). This study aimed to assess the prevalence of insomnia in Saudi patients with ESRD who are on maintenance dialysis. Methods This was an observational cross-sectional study carried out over a period of five months in two hemodialysis centers in Saudi Arabia. To assess the prevalence of insomnia, we used the ICSD-2 definition. We also examined the association betwee...

  9. Insomnia with objective short sleep duration is associated with longer duration of insomnia in the Freiburg Insomnia Cohort compared to insomnia with normal sleep duration, but not with hypertension.

    Science.gov (United States)

    Johann, Anna F; Hertenstein, Elisabeth; Kyle, Simon D; Baglioni, Chiara; Feige, Bernd; Nissen, Christoph; McGinness, Alastair J; Riemann, Dieter; Spiegelhalder, Kai

    2017-01-01

    To replicate the association between insomnia with objective short sleep duration and hypertension, type 2 diabetes and duration of insomnia. Retrospective case-control study. Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg. 328 patients with primary insomnia classified according to DSM-IV criteria (125 males, 203 females, 44.3 ± 12.2 years). N/A. All participants were investigated using polysomnography, blood pressure measurements, and fasting routine laboratory. Insomnia patients with short sleep duration (insomnia compared to those with normal sleep duration (≥ 6 hours) in the first night of laboratory sleep. Insomnia patients who were categorised as short sleepers in either night were not more likely to suffer from hypertension (systolic blood pressure of ≥ 140 mm Hg, diastolic blood pressure of ≥ 90 mm Hg, or a previously established diagnosis). Data analysis showed that insomnia patients with objective short sleep duration were not more likely to suffer from type 2 diabetes (fasting plasma glucose level of ≥ 126 mg/dl, or a previously established diagnosis). However, the diabetes analysis was only based on a very small number of diabetes cases. As a new finding, insomnia patients who were categorised as short sleepers in either night presented with increases in liver enzyme levels. The finding on insomnia duration supports the concept of two distinct sub-groups of insomnia, namely insomnia with, and without, objectively determined short sleep duration. However, our data challenges previous findings that insomnia patients with short sleep duration are more likely to suffer from hypertension.

  10. Insomnia and its associations in patients with recurrent glial neoplasms

    OpenAIRE

    Robertson, Matthew E.; McSherry, Frances; Herndon, James E.; Peters, Katherine B.

    2016-01-01

    Background Patient with neurological disorders and cancer can develop sleep disturbance, in particular insomnia. Etiology of insomnia is multi-factorial in primary brain tumour patients with possible causes including corticosteroids, psychoactive medications, co-morbid psychiatric/medical conditions, and damage to neuronal tissue. Findings To understand better insomnia in recurrent glioma patients, a single-center retrospective analysis was performed looking at recurrent glioma patients from ...

  11. [Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

    Science.gov (United States)

    Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

    2012-03-01

    Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

  12. Translating the insomnia severity index into Arabic.

    Science.gov (United States)

    Suleiman, Khaled H; Yates, Bernice C

    2011-03-01

    The purpose of this study was to translate the Insomnia Severity Index (ISI) into Arabic (Fusha dialect), and obtain preliminary reliability and validity estimates for the translated version. Arabic populations experience sleep problems that interfere with their vitality and quality of life. The ISI was established to screen for insomnia in both clinical and research situations. This study used a descriptive correlational design. The ISI was translated into Arabic using the back-translation method and compared with three other sleep measures: the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, and the Vitality Subscale from the Medical Outcomes Study Short Form-36. These measures were administered to 35 healthy Arabic bilingual participants from three community locations. The mean ISI score was 9.2 (SD = 5.8; range 0-20). Internal consistency reliability was 0.84. The correlations between the total ISI score and the single items ranged from 0.49 to 0.92 (p translated ISI demonstrated adequate reliability and validity. The translated ISI needs further testing in a larger sample of both clinical and healthy Arabic populations in their own countries. Preliminary psychometric estimates show that the translated ISI is reliable and valid in this community-dwelling Arabic sample. The translated ISI allows for Arabic researchers to screen for insomnia and plan for future intervention studies. © 2011 Sigma Theta Tau International.

  13. New onset of insomnia in hospitalized patients in general medical wards: incidence, causes, and resolution rate

    OpenAIRE

    Ho, An; Raja, Bronson; Waldhorn, Richard; Baez, Valentina; Mohammed, Idiris

    2017-01-01

    ABSTRACT Background: Insomnia is common in hospitalized patients. However, no study has examined new onset of insomnia in patients without a prior history of insomnia. Objectives: Incidence of new onset of insomnia in inpatients, associated factors and resolution rate after 2 weeks. Method: This is a prospective observational study conducted at a community hospital. We used the Insomnia Severity Index questionnaire to screen for insomnia in all patients located in the general medical floors f...

  14. The Effects of Insomnia and Sleep Loss on Cardiovascular Disease.

    Science.gov (United States)

    Khan, Meena S; Aouad, Rita

    2017-06-01

    Sleep loss has negative impacts on quality of life, mood, cognitive function, and heath. Insomnia is linked to poor mood, increased use of health care resources, decreased quality of life, and possibly cardiovascular risk factors and disease. Studies have shown increase in cortisol levels, decreased immunity, and increased markers of sympathetic activity in sleep-deprived healthy subjects and those with chronic insomnia. The literature shows subjective complaints consistent with chronic insomnia and shortened sleep can be associated with development of diabetes, hypertension, and cardiovascular disease. This article explores the relationship between insufficient sleep and insomnia with these health conditions. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. The value of mindfulness meditation in the treatment of insomnia.

    Science.gov (United States)

    Martires, Joanne; Zeidler, Michelle

    2015-11-01

    Insomnia is the most common reported sleep disorder with limited treatment options including pharmacotherapy and cognitive behavioral therapy for insomnia. Pharmacotherapy can be complicated by tolerance and significant side-effects and cognitive behavioral therapy for insomnia providers are limited in number. This article reviews mindfulness meditation as an additional therapy for insomnia. Both mindfulness-based stress reduction (MBSR) and mindfulness-based therapy for insomnia (MBTI) have been studied in the treatment of insomnia. Randomized controlled studies of MBSR and MBTI have shown overall reduction in sleep latency and total wake time and increase in total sleep time after mindfulness therapy using both patient reported outcome and quantitative measures of sleep. Mindfulness techniques have been shown to be well accepted by patients with long-lasting effects. A three-arm randomized study with MBSR, MBTI, and self-monitoring showed similar improvement in insomnia between the MBSR and MBTI groups, with possibly longer duration of efficacy in the MBTI group. Recent data show that MBTI is also an effective and accepted treatment for insomnia in older patients. Increasing evidence shows that mindfulness meditation, delivered either via MBSR or MBTI, can be successfully used for the treatment of insomnia with good patient acceptance and durable results.

  16. Prevalence, predictors and correlates of insomnia in US army soldiers.

    Science.gov (United States)

    Klingaman, Elizabeth A; Brownlow, Janeese A; Boland, Elaine M; Mosti, Caterina; Gehrman, Philip R

    2017-10-11

    The objective of this study was to investigate the rates, predictors and correlates of insomnia in a national sample of US Army soldiers. Data were gathered from the cross-sectional survey responses of the All-Army Study, of the Army Study to Assess Risk and Resilience in Service members. Participants were a representative sample of 21 499 US Army soldiers who responded to the All-Army Study self-administered questionnaire between 2011 and 2013. Insomnia was defined by selected DSM-5 criteria using the Brief Insomnia Questionnaire. The results highlight significant functional difficulties associated with insomnia among US soldiers, as well as insights into predictors of insomnia specific to this population. Insomnia was present in 22.76% of the sample. Predictors of insomnia status in logistic regression included greater number of current mental health disorders, less perceived open lines of communication with leadership, less unit member support and less education. Insomnia had global, negative associations with health, social functioning, support, morale, work performance and Army career intentions. The results provide the strongest evidence to-date that insomnia is common in a military population, and is associated with a wide array of negative factors in the domains of health, military readiness and intentions to remain in military careers. © 2017 European Sleep Research Society.

  17. Diagnosis and Treatment of Insomnia Comorbid with Obstructive Sleep Apnea.

    Science.gov (United States)

    Lack, Leon; Sweetman, Alexander

    2016-09-01

    Insomnia is often comorbid with obstructive sleep apnea. It reduces positive airway pressure (PAP) therapy acceptance and adherence. Comorbid patients show greater daytime impairments and poorer health outcomes. The insomnia often goes undiagnosed, undertreated, or untreated. Pharmacotherapy is not recommended for long-term treatment. Although care should be taken administering behavioral therapies to patients with elevated sleepiness, cognitive behavior therapy for insomnia (CBTi) is an effective and durable nondrug therapy that reduces symptoms and may increase the effectiveness of PAP therapy. Sleep clinics should be alert to comorbid insomnia and provide adequate diagnostic tools and clinicians with CBTi expertise. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Insomnia in Sweden: A Population-Based Survey

    OpenAIRE

    Mallon, Lena; Broman, Jan-Erik; Åkerstedt, Torbjörn; Hetta, Jerker

    2014-01-01

    Aims. Estimate the prevalence of insomnia and examine effects of sex, age, health problems, sleep duration, need for treatment, and usage of sleep medication. Methods. A sample of 1,550 subjects aged 18–84 years was selected for a telephone interview. The interview was completed by 1,128 subjects (72.8%). Results. 24.6% reported insomnia symptoms. Insomnia disorder, that is, insomnia symptoms and daytime consequences, was reported by 10.5%. The prevalence was similar among all age groups, wit...

  19. Clinical correlates of insomnia in patients with acute coronary syndrome.

    Science.gov (United States)

    Coryell, Virginia T; Ziegelstein, Roy C; Hirt, Kellie; Quain, Angela; Marine, Joseph E; Smith, Michael T

    2013-01-01

    This study sought to examine the prevalence of insomnia and its association with depression, anxiety, and medical comorbidities in patients after an acute coronary syndrome (ACS). Insomnia increases risk of recurrent cardiac events in ACS patients, but little is known about the prevalence and clinical correlates of insomnia in this setting. Patients (n = 102, 58.3 ± 10.6 years-old) admitted for ACS to a cardiology service at an urban academic medical center completed the Insomnia Severity Index, Epworth Sleepiness Scale, and measures of depression and anxiety. A subset (n = 20) completed ambulatory polysomnography (PSG) in their homes several weeks after discharge. Moderate or severe insomnia was reported by 37% of patients during hospitalization and was associated with 76 minutes more wake after sleep onset measured by home PSG. Although depression and insomnia were strongly associated, about 1 in 4 patients with insomnia did not report significant depressive symptoms. Sleep apnea was documented in 80% of patients on PSG, but insomnia was not associated with sleep apnea, periodic limb movements, demographic factors, or medical conditions other than liver disease. Insomnia is present in over one-third of ACS patients during hospitalization, but at-risk patients could not be readily identified by demographic or medical factors or by depression symptoms.

  20. Treating Acute Insomnia: A Randomized Controlled Trial of a "Single-Shot" of Cognitive Behavioral Therapy for Insomnia.

    Science.gov (United States)

    Ellis, Jason G; Cushing, Toby; Germain, Anne

    2015-06-01

    Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia. A pragmatic parallel group randomized controlled trial. Community. Forty adults (mean age 32.9 ± 13.72 y) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined insomnia disorder, except a self-reported duration of less than 3 mo (i.e., acute insomnia), who reported no previous exposure to CBT-I and were not currently taking medication for sleep. A single 60- to 70-min session of CBT-I (n = 20), with an accompanying self-help pamphlet, or wait list control group (n = 20). All subjects were offered a full individual course of CBT-I on completion of the study, regardless of group allocation. Subjects completed sleep diaries and the Insomnia Severity Index (ISI) pretreatment and 1 mo following treatment. There were no between-group differences on baseline ISI scores or subjective sleep continuity. The intervention group reported significantly lower ISI scores than controls (t(38) 2.24, P insomnia caseness (i.e., ≥ 10), 60% of those in the CBT-I group had remitted by 1 mo compared to 15% of those in the control group. This single session of cognitive behavioral therapy for insomnia (CBT-I) is sufficiently efficacious for a significant proportion of those with acute insomnia. The results are discussed in terms of integrating this brief form of CBT-I into the "stepped care" model of insomnia. Testing the efficacy of an early intervention for acute insomnia (SRCTN05891695) http://www.controlled-trials.com/ISRCTN05891695. © 2015 Associated Professional Sleep Societies, LLC.

  1. Insomnia among community dwelling elderly in Alexandria, Egypt.

    Science.gov (United States)

    Ayoub, Abla I; Attia, Medhat; El Kady, Heba M; Ashour, Ayat

    2014-12-01

    Insomnia is a common problem in the elderly population. Poor sleep quality is associated with decreased memory and concentration, increased risk of falls, cognitive decline, and higher rate of mortality. Inadequate sleep hygiene such as irregular sleep schedules, use of stimulants, and daytime naps may predispose to insomnia. The aim of this study was to determine the prevalence of insomnia among community dwelling elderly in Alexandria and to assess some of the risk factors and comorbid conditions related to insomnia. This is a cross-sectional study conducted among 380 elderly people taken from different clubs in Alexandria using a predesigned structured interview questionnaire. Data on sociodemographic characteristics, medical history, and personal and sleeping habits were collected. The Insomnia Severity Index was used to assess insomnia and the Depression Anxiety Stress Scale was used to measure depression, anxiety, and stress. One-third (33.4%) of the elderly suffered from insomnia. On logistic regression, the most independent factors that were significantly associated with insomnia were number of chronic diseases [odds ratio (OR)=7.25 for having ≥5 diseases], being female (OR=2.37), anxiety (OR=1.91), watching television in bed before sleeping (OR=1.90), depression (OR=1.74), nocturia (OR=1.13), and daily sunlight exposure (OR=0.57). Insomnia is a common problem among the elderly in Alexandria. Female sex, chronic diseases, mental health problems, and bad sleep hygiene practice increase the risk for insomnia. Improving knowledge among the elderly about the prevalence and risk factors of insomnia could help the development of effective public health prevention and intervention programs for better sleep quality.

  2. Analysis of insomnia in those over 60 year of age

    Directory of Open Access Journals (Sweden)

    Weronika Wolińska

    2016-12-01

    Full Text Available Background . Insomnia means an absolute lack of sleep; however, in reality, it is a more complex phenomenon. Insomnia is characterized by an insufficient quantity or quality of sleep. For diagnosis of insomnia, it is crucial to find out about the patient’s subjective feelings. Loneliness is a phenomenon that people experience in an individual way – subjectively. The problems with sleep intensify with age, which can consequently cause depression. Depression is conducive to loneliness, both as a temporary feeling as well as a continual feeling of loneliness and exclusion. Objectives. The aim of this research was to the evaluation of frequency of insomnia among individuals over 60 years of age - students of the University of the Third Age in Stargard. Material and methods . The research was conducted among 131 individuals aged 60 years and over, including 72.51% (n = 95 females and 27.48% (n = 36 males. The mean age was 68.12 ± 6.63. The survey was used with elements of the Athens Insomnia Scale (AIS , Insomnia Severity Index (ISI , Beck Depression Inventory and the author’s proprietary questionnaire with socio-economic data. Results . Insomnia was observed among 27.48% (n = 36 of the respondents surveyed with AIS . More than 25% (n = 33 of respondents scored on the borderline for diagnosis of insomnia. The results obtained by combining the Beck Depression Inventory with Athens Insomnia Scale show a statistically significant relationship between insomnia and depression (p = 0.0001. Conclusions . Insomnia is present in more than a quarter of respondents among persons above 60 years of age, being students of the University of the Third Age in Stargard.

  3. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).

    Science.gov (United States)

    Takahashi, Tomohiko; Hayata, Satoru; Kobayashi, Akihiro; Onaka, Yuna; Ebihara, Takeshi; Hara, Terufumi

    2018-03-01

    Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. PAH patients aged 15 years or older were subjected to the analysis. The safety analysis by overall cases or stratification of patient backgrounds and the efficacy analysis were investigated. Regarding patient characteristics, the 702 patients subjected to safety analysis included 543 (77.4%) women and 546 (77.8%) patients at WHO functional class II/III. The mean observational time was 392.7 days. A total of 324 adverse drug reaction (ADR) occurred in 204 (29.1%) patients. Common ADRs (≥ 2%) included anemia (4.6%), peripheral edema (4.1%), headache (3.6%), edema and face edema (2.6% each), abnormal hepatic function (2.3%), and epistaxis (2.1%). There were 82 serious ADRs occurring in 44 (6.3%) patients (385 serious adverse events in 184 (26.2%) patients). Although 11 (1.6%) interstitial lung disease (ILD) cases were reported, all were observed in patients with disease that may contribute to ILD and therefore it is difficult to assess if ambrisentan was associated with these events. There was no difference in safety in relation to the presence/absence of connective tissue disease-related PAH (CTD-PAH) or combination therapy. Among 677 patients subjected to efficacy analysis, those in whom hemodynamic status was determined before and after treatment showed improvement in the mean pulmonary arterial pressure and pulmonary vascular resistance after treatment. The interim results showed safety consistent with the known profile of ambrisentan in terms of the types and frequencies of ADRs in patients with PAH in real clinical practice, in comparison with

  4. Organizational justice and insomnia: Relationships between justice components and insomnia symptoms among private company workers in Japan.

    Science.gov (United States)

    Hayashi, Toshio; Odagiri, Yuko; Takamiya, Tomoko; Ohya, Yumiko; Inoue, Shigeru

    2015-01-01

    Organizational justice (OJ) is an important psychosocial factor and it consists of several components. Previous studies have shown that low perceived OJ is associated with various health problems. However, the relationships between each justice component and health outcomes have not been fully examined. The purpose of this study was to clarify the relationships between OJ and insomnia, including OJ components and insomnia symptoms. Cross-sectional self-reported questionnaire data from 1,893 employees (92.2% of subjects) were collected. OJ was measured using the Japanese version of the OJ questionnaire, which has four components (distributive, procedural, interpersonal and informational). Insomnia was assessed with the Athens Insomnia Scale. Logistic regression analysis, with insomnia as a dependent variable and OJ as an independent variable, was conducted. Subjects with low overall OJ had a higher risk of insomnia (adjusted odds ratio (AOR), 2.37; 95% confidence interval (CI), 1.59 to 3.53) and two insomnia symptoms (AOR of 2.47 and 95% CI of 1.68 to 3.65 for sleep induction problem; AOR of 1.73 and 95% CI of 1.21 to 2.48 for sleep maintenance problem). The four justice components were all associated with insomnia and sleep induction problems. Sleep maintenance problems were associated with only the distributive justice component. All four justice components were associated with both insomnia and sleep induction problems. Sleep maintenance problems, however, showed different features. Specifically, the distributive justice component seemed to be a key factor in the relationship between OJ and insomnia. These findings might provide useful information for preventing the adverse effects of insomnia.

  5. On insomnia analysis using methods of artificial intelligence

    Science.gov (United States)

    Wasiewicz, P.; Skalski, M.

    2011-10-01

    Insomnia generally is defined as a subjective report of difficulty falling sleep, difficulty staying asleep, early awakening, or nonrestorative sleep. It is one of the most common health complaints among the general population. in this paper we try to find relationships between different insomnia cases and predisposing, precipitating, and perpetuating factors following by pharmacological treatment.

  6. Associations between insomnia, sleep duration and poor work ability.

    Science.gov (United States)

    Lian, Yulong; Xiao, Jing; Liu, Yan; Ning, Li; Guan, Suzhen; Ge, Hua; Li, Fuye; Liu, Jiwen

    2015-01-01

    The aim of this study was to examine the independent and joint effect of insomnia and objective sleep duration on poor work ability. In this cross-sectional study, a total of 2820 Chinese manufacturing workers were categorized as insomnia patients and individuals with normal sleeping pattern by interview according to DSM-IV criteria. Sleep duration was classified into four categories: ≥7h, 6-7h, 5-6h, and sleep duration of Watch-PAT-200 test. Work ability was assessed using the Chinese Work Ability Index (WAI) questionnaire. Regression analysis examined the independent and joint association of sleep duration and insomnia with poor work ability, after adjusting for various confounding factors. Insomnia and objective short sleep duration were both independently associated with poor work ability. Compared with the normal sleeping and ≥7h sleep duration group, the highest risk of poor work ability was in the insomnia patients with sleep duration [odds ratio (OR) 3.43, 95% confidence interval (CI) 1.87-5.23], followed by the individuals with insomnia who slept 5-6h (OR 2.03, 95% CI 1.42-2.67). Insomnia and sleep duration in workers are both separately and together associated with increased risk of poor work ability. Objective sleep duration should be taken into consideration when assessing the work ability of people with insomnia. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. Psychosocial Correlates of Insomnia in an Adolescent Population

    Science.gov (United States)

    Siomos, Konstantinos E.; Avagianou, Penelope-Alexia; Floros, Georgios D.; Skenteris, Nikolaos; Mouzas, Odysseas D.; Theodorou, Kyriaki; Angelopoulos, Nikiforos V.

    2010-01-01

    This study examines the nature of the relationship between psychosocial factors and insomnia complaints in an adolescent non-clinical population. It is a cross-sectional study of a stratified sample of 2,195 Greek adolescent high-school students. Subjects were given the Athens insomnia scale, the Symptom Checklist scale (SCL-90-R) and a…

  8. Increased hippocampal-prefrontal functional connectivity in insomnia

    NARCIS (Netherlands)

    Leerssen, Jeanne; Wassing, Rick; Ramautar, Jennifer R; Stoffers, Diederick; Lakbila-Kamal, Oti; Perrier, Joy; Bruijel, Jessica; Foster-Dingley, Jessica C; Aghajani, Moji; van Someren, Eus J W

    2018-01-01

    Insomnia Disorder (ID) is the second-most common mental disorder and has a far-reaching impact on daytime functioning. A meta-analysis indicates that, of all cognitive domains, declarative memory involving the hippocampus is most affected in insomnia. Hippocampal functioning has consistently been

  9. Insomnia in central neurologic diseases--occurrence and management

    DEFF Research Database (Denmark)

    Mayer, Geert; Jennum, Poul; Riemann, Dieter

    2011-01-01

    antidepressants may be an effective treatment for insomnia in stroke and Parkinson's disease (PD) patients. Melatonin and light treatment can stabilize the sleep-wake circadian rhythm and shorten sleep latency in dementias and PD. Cognitive behavioral therapy (CBT) can be effective in treating insomnia symptoms...

  10. Health economics of insomnia therapy: implications for policy.

    Science.gov (United States)

    Botteman, Marc

    2009-09-01

    Chronic primary insomnia is a major public health problem causing significant burden for those affected. Rising health care costs may cause increased financial pressures on governments and private payers, forcing stricter cost-control measures and, as a result, insomnia, often considered a lifestyle condition, may not receive the proper attention it deserves. In order to highlight the benefits that can be achieved through successful treatment of insomnia, there is a need for further comparative studies of existing and emerging treatments, cost burden of illness and cost-effectiveness analyses. Health economic assessment of insomnia and its treatments is an emerging area. The development of comprehensive assessment of insomnia treatments, however, has been hindered by complexities and gaps in the available data. Health economic models of insomnia, such as the one detailed here, should enable researchers to better address the effects of different treatments on clinical and economic measures for insomnia and related comorbidities. It is apparent that research into the cost-effectiveness of therapies for insomnia is in its infancy and further work is needed.

  11. [Management of insomnia and hypersomnia associated with psychiatric disorders].

    Science.gov (United States)

    Uchiyama, Makoto; Suzuki, Masahiro; Konno, Chisato; Furihata, Ryuji; Osaki, Koichi; Konno, Michiko; Takahashi, Sakae

    2010-01-01

    Most psychiatric disorders, such as schizophrenia, mood disorders, or neurotic disorders are associated with sleep disorders of various kinds, among which insomnia is most prevalent and important in psychiatric practice. Almost all patients suffering from major depression complain of insomnia. Pharmacological treatment of insomnia associated with major depression shortens the duration to achieve remission of depression. Insomnia has been recently reported to be a risk factor for depression. Hypersomnia is also a major sleep problem in patient suffering from depression. There have been no clinical guide to treat the symptoms of hypersomnia in depression, but some clinical trials treating them with NDRI or adjunctive administration of psychostimulants. In patients with schizophrenia, insomnia is often an early indicator of the aggravation of psychotic symptoms. Electroencephalographic sleep studies have also revealed sleep abnormalities characteristic to mood disorders, schizophrenia and anxiety disorders. A shortened REM sleep latency has been regarded as a biological marker of depression. Reduced amount of deep Non-REM sleep has been reported to be correlated with negative symptoms of schizophrenia. Recently, REM sleep abnormalities were found in teenagers having post-traumatic stress disorder after a boat accident. Although these facts indicate that insomnia plays an important role in the development of psychiatric disorders, there are few hypotheses explaining the cause and effect of insomnia in these disorders. Here, we reviewed recent articles on insomnia and hypersomnia associated with psychiatric disorders together with their clinical managements.

  12. Insomnia in chronic renal patients on dialysis in Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Al-Hejaili Fayez F

    2010-06-01

    Full Text Available Abstract Background Studies have shown that insomnia is a common sleep disorder among patients with end-stage renal disease (ESRD. This study aimed to assess the prevalence of insomnia in Saudi patients with ESRD who are on maintenance dialysis. Methods This was an observational cross-sectional study carried out over a period of five months in two hemodialysis centers in Saudi Arabia. To assess the prevalence of insomnia, we used the ICSD-2 definition. We also examined the association between insomnia and other sleep disorders, the underlying causes of renal failure, dialysis duration, dialysis shift, and other demographic data. Results Out of 227 enrolled patients, insomnia was reported by 60.8%. The mean patient age was 55.7 ± 17.2 years; 53.7% were male and 46.3% were female. Insomnia was significantly associated with female gender, afternoon hemodialysis, Restless Legs Syndrome, high risk for obstructive Sleep Apnea Syndrome and excessive daytime sleepiness (P-values: 0.05, 0.01, Conclusion Insomnia is common in dialysis patients and was significantly associated with other sleep disorders. Greater attention needs to be given to the care of dialysis patients with regard to the diagnosis and management of insomnia and associated sleep disorders.

  13. Prevalence and Polysomnographic Correlates of Insomnia Comorbid with Medical Disorders

    Science.gov (United States)

    Budhiraja, Rohit; Roth, Thomas; Hudgel, David W.; Budhiraja, Pooja; Drake, Christopher L.

    2011-01-01

    Study Objectives: To determine the prevalence and polysomnographic correlates of insomnia in subjects with self-reported medical disorders. Design: Prospective cross-sectional study. Participants: Community-based sample of 3282 men and women aged 18 to 65 years old, with a subset who underwent polysomnography. Measurements: Self-reported measures of sleep habits and current health, and polysomnographic sleep variables. Results: The prevalence of insomnia was 21.4%. The adjusted odds of insomnia were 2.2 times as high in persons with any medical disorders as in those without medical disorders. Specifically, odds of insomnia were higher in people with heart disease (OR = 1.6 [95% CI: 1.2-23], P = 0.004), hypertension (1.5 [12-18], P insomnia increased with increasing number of medical disorders. However, polysomnographic sleep was not significantly different in persons with or without medical disorders for most disorders assessed. Conclusion: This large population-based study suggests that insomnia is highly prevalent in diverse chronic medical disorders. However, polysomnographic evidence of disturbed sleep is present in only a subset of comorbid insomnia populations. Citation: Budhiraja R; Roth T; Hudgel DW; Budhiraja P; Drake CL. Prevalence and polysomnographic correlates of insomnia comorbid with medical disorders. SLEEP 2011;34(7):859-867. PMID:21731135

  14. Insomnia: psychological and neurobiological aspects and non-pharmacological treatments

    Directory of Open Access Journals (Sweden)

    Yara Fleury Molen

    2014-01-01

    Full Text Available Insomnia involves difficulty in falling asleep, maintaining sleep or having refreshing sleep. This review gathers the existing informations seeking to explain insomnia, including those that focus on psychological aspects and those considered neurobiological. Insomnia has been defined in psychological (cognitive components, such as worries and rumination, and behavioral aspects, such as classic conditioning and physiological terms (increased metabolic rate, with increased muscle tone, heart rate and temperature. From the neurobiological point of view, there are two perspectives: one which proposes that insomnia occurs in association with a failure to inhibit wakefulness and another that considers hyperarousal as having an important role in the physiology of sleep. The non-pharmacological interventions developed to face different aspects of insomnia are presented.

  15. [Management of adult secondary insomnia in primary health care].

    Science.gov (United States)

    Cavadas, Luís Filipe; Ribeiro, Lúcia

    2011-01-01

    Insomnia is the most common sleep disorder in adults, with secondary insomnia being the most prevalent. This sleep disorder is associated with important medical and social consequences. The General Practitioner (GP) plays a key role in the diagnosis of insomnia, which may affect about 69% of their patients in the PHC (Primary Health Care). Recognize the differential diagnosis of secondary insomnia in adults, evaluate and manage these patients in the PHC, appropriately use the treatments available and meet the criteria for referral. Bibliographic search in MEDLINE databases, and evidence based review databases, using the MeSH terms: Primary Health Care, Sleep Disorders, Insomnia, for articles published since January 2000 until July 2009, in English, Portuguese, French and Spanish. Index de Revistas Médicas Portuguesas and scientific societies dedicated to sleep disorders were searched. Mood and anxiety disorders are the main co-morbidities associated with secondary insomnia, being present in 30% to 50% of patients with insomnia. The medical pathology and substance abuse are present respectively in 10% of patients. It is essential a proper clinical history, with a history of sleep, sleep diary and the partner information. There is evidence that the combination of specific pharmacological treatments (benzodiazepines and the benzodiazepine receptor agonists) with the nonpharmacological (cognitive-behavioral therapy) may be useful in secondary insomnia, as co-adjuvant treatment of the underlying disease. There are several treatment options with their indications and adverse effects. The criteria for referral should be defined according to the availability of human resources. Due to the high prevalence and the serious consequences of secondary insomnia in adults, it must be systematically managed by the GP. It is important to know and to use non-pharmacological therapy in GP consultation, because this therapy was shown to be important in treating this type of insomnia

  16. Sleep Reactivity and Insomnia: Genetic and Environmental Influences

    Science.gov (United States)

    Drake, Christopher L.; Friedman, Naomi P.; Wright, Kenneth P.; Roth, Thomas

    2011-01-01

    Study Objectives: Determine the genetic and environmental contributions to sleep reactivity and insomnia. Design: Population-based twin cohort. Participants: 1782 individual twins (988 monozygotic or MZ; 1,086 dizygotic or DZ), including 744 complete twin pairs (377 MZ and 367 DZ). Mean age was 22.5 ± 2.8 years; gender distribution was 59% women. Measurements: Sleep reactivity was measured using the Ford Insomnia Response to Stress Test (FIRST). The criterion for insomnia was having difficulty falling asleep, staying asleep, or nonrefreshing sleep “usually or always” for ≥ 1 month, with at least “somewhat” interference with daily functioning. Results: The prevalence of insomnia was 21%. Heritability estimates for sleep reactivity were 29% for females and 43% for males. The environmental variance for sleep reactivity was greater for females and entirely due to nonshared effects. Insomnia was 43% to 55% heritable for males and females, respectively; the sex difference was not significant. The genetic variances in insomnia and FIRST scores were correlated (r = 0.54 in females, r = 0.64 in males), as were the environmental variances (r = 0.32 in females, r = 0.37 in males). In terms of individual insomnia symptoms, difficulty staying asleep (25% to 35%) and nonrefreshing sleep (34% to 35%) showed relatively more genetic influences than difficulty falling asleep (0%). Conclusions: Sleep reactivity to stress has a substantial genetic component, as well as an environmental component. The finding that FIRST scores and insomnia symptoms share genetic influences is consistent with the hypothesis that sleep reactivity may be a genetic vulnerability for developing insomnia. Citation: Drake CL; Friedman NP; Wright KP; Roth T. Sleep reactivity and insomnia: genetic and environmental influences. SLEEP 2011;34(9):1179-1188. PMID:21886355

  17. Insomnia in hemodialysis patients: A multicenter study from morocco

    Directory of Open Access Journals (Sweden)

    Mohamed Amine Hamzi

    2017-01-01

    Full Text Available Previous studies have shown that insomnia is a common sleep disorder in patients with end-stage renal disease. This study aims to determine the prevalence and risk factors of insomnia in our chronic hemodialysis (HD patients. This is a cross-sectional study conducted in three HD units in Morocco. To assess the prevalence of insomnia, we used a specific questionnaire. Patients complaining of difficulty in falling asleep and/or nocturnal awakenings occurring seven nights a week during the last month were included in the group “insomnia;” the other patients were used as controls. Clinical, biological, and dialysis data were recorded for each patient. Sleep disorders and their subjective causes were also identified. Eighty-nine percent of questioned patients admitted to having sleep disturbances of different degrees. Insomnia was significantly associated with female gender and time of dialysis. Age, body mass index, inter-dialytic weight gain, and blood pressure were similar between the two groups, as well as dialytic parameters and drug use. There was no significant difference in the values of plasma creatinine, urea, hemoglobin, parathyroid hormone, calcium, phosphorus, C-reactive protein, and albumin between the groups. Disorders most frequently encountered in patients with insomnia were waking up at night (90%, difficulty falling asleep (60%, and daytime sleepiness (60%. The restless legs syndrome was seen in half of these patients. The main reported causes of insomnia were anxiety and/or depression (70% and bone pain (67%. Insomnia is common in HD patients and is frequently associated with other disorders of sleep. Female sex and duration on dialysis are the two risk factors found in our study. Insomnia does not appear related to any biochemical or dialysis parameters. Increased attention should be given to the management of dialysis patients regarding the diagnosis and management of insomnia and associated sleep disorders.

  18. Effect of acute physical exercise on patients with chronic primary insomnia.

    Science.gov (United States)

    Passos, Giselle S; Poyares, Dalva; Santana, Marcos G; Garbuio, Silvério A; Tufik, Sergio; Mello, Marco Túlio

    2010-06-15

    The aim was to assess and to compare the acute effects of three different modalities of physical exercise on sleep pattern of patients with chronic primary insomnia. Forty-eight insomnia patients, 38 female (mean age 44.4 +/- 8 y) were randomly assigned to 4 groups: control (CTR, n=12), moderate-intensity aerobic exercise (MAE, n=12), high-intensity aerobic exercise (HAE, n=12), and moderate-intensity resistance exercise (MRE, n=12). The patients were assessed on sleep pattern (by polysomnogram and daily sleep log) and anxiety (STAI) before and after the acute exercise. The polysomnogram data showed reduction in the sleep onset latency (SOL) (55%) and in the total wake time (TWT) (30%); increase in total sleep time (TST) (18%), and in the sleep efficiency (SE) (13%) in the MAE group. The daily sleep log data showed increase in the TST (26%) and reduction in the SOL (39%). In addition, reduction (15%) in anxiety was also observed after moderate-intensity aerobic exercise. Acute moderate-intensity aerobic exercise appears to reduce pre-sleep anxiety and improve sleep in patients with chronic primary insomnia.

  19. Cognitive Behavioural Therapy for Insomnia (CBT-I) to treat depression: A systematic review.

    Science.gov (United States)

    Cunningham, Jasmyn E A; Shapiro, Colin M

    2018-03-01

    Major depressive disorder is one of the most commonly diagnosed psychiatric illnesses, and it has a profound negative impact on an individual's ability to function. Up to 90% of individuals suffering from depression also report sleep and circadian disruptions. If these disruptions are not effectively resolved over the course of treatment, the likelihood of relapse into depression is greatly increased. Cognitive Behavioural Therapy for Insomnia (CBT-I) has shown promise in treating these sleep and circadian disturbances associated with depression, and may be effective as a stand-alone treatment for depression. This may be particularly relevant in cases where antidepressant medications are not ideal (e.g. due to contraindications, cost, or treatment resistance). A systematic literature review was conducted of trials investigating the use of CBT-I to treat depression in adults. Therapy included in-person CBT-I, as well as telehealth and group CBT-I. CBT-I presents a promising treatment for depression comorbid with insomnia. In-person therapy has the most supporting evidence for its efficacy, though treatment effects may not be additive with those of antidepressant medications. Insomnia improvement due to CBT-I may mediate the improvement in depressive symptoms. There is less evidence for the use of telehealth, though a stepped-care approach is indicated based on baseline depressive severity. More research on group therapy and telehealth modalities of delivering CBT-I are required before making recommendations. Copyright © 2018 Elsevier Inc. All rights reserved.

  20. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia.

    Science.gov (United States)

    Manber, Rachel; Edinger, Jack D; Gress, Jenna L; San Pedro-Salcedo, Melanie G; Kuo, Tracy F; Kalista, Tasha

    2008-04-01

    Insomnia impacts the course of major depressive disorder (MDD), hinders response to treatment, and increases risk for depressive relapse. This study is an initial evaluation of adding cognitive behavioral therapy for insomnia (CBTI) to the antidepressant medication escitalopram (EsCIT) in individuals with both disorders. A randomized, controlled, pilot study in a single academic medical center. 30 individuals (61% female, mean age 35 +/- 18) with MDD and insomnia. EsCIT and 7 individual therapy sessions of CBTI or CTRL (quasi-desensitization). Depression was assessed with the HRSD17 and the depression portion of the SCID, administered by raters masked to treatment assignment, at baseline and after 2, 4, 6, 8, and 12 weeks of treatment. The primary outcome was remission of MDD at study exit, which required both an HRSD17 score insomnia severity index (ISI), daily sleep diaries, and actigraphy. EsCIT + CBTI resulted in a higher rate of remission of depression (61.5%) than EsCIT + CTRL (33.3%). EsCIT + CBTI was also associated with a greater remission from insomnia (50.0%) than EsCIT + CTRL (7.7%) and larger improvement in all diary and actigraphy measures of sleep, except for total sleep time. This pilot study provides evidence that augmenting an antidepressant medication with a brief, symptom focused, cognitive-behavioral therapy for insomnia is promising for individuals with MDD and comorbid insomnia in terms of alleviating both depression and insomnia.

  1. Treating Acute Insomnia: A Randomized Controlled Trial of a “Single-Shot” of Cognitive Behavioral Therapy for Insomnia

    Science.gov (United States)

    Ellis, Jason G.; Cushing, Toby; Germain, Anne

    2015-01-01

    Study Objectives: Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia. Design: A pragmatic parallel group randomized controlled trial. Setting: Community. Participants: Forty adults (mean age 32.9 ± 13.72 y) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined insomnia disorder, except a self-reported duration of less than 3 mo (i.e., acute insomnia), who reported no previous exposure to CBT-I and were not currently taking medication for sleep. Interventions: A single 60- to 70-min session of CBT-I (n = 20), with an accompanying self-help pamphlet, or wait list control group (n = 20). All subjects were offered a full individual course of CBT-I on completion of the study, regardless of group allocation. Measurements and Results: Subjects completed sleep diaries and the Insomnia Severity Index (ISI) pretreatment and 1 mo following treatment. There were no between-group differences on baseline ISI scores or subjective sleep continuity. The intervention group reported significantly lower ISI scores than controls (t(38) 2.24, P insomnia caseness (i.e., ≥ 10), 60% of those in the CBT-I group had remitted by 1 mo compared to 15% of those in the control group. Conclusions: This single session of cognitive behavioral therapy for insomnia (CBT-I) is sufficiently efficacious for a significant proportion of those with acute insomnia. The results are discussed in terms of integrating this brief form of CBT-I into the “stepped care” model of insomnia. Trial Registration: Testing the efficacy of an early intervention for acute insomnia (SRCTN05891695) http://www.controlled-trials.com/ISRCTN05891695. Citation: Ellis JG, Cushing T, Germain A. Treating acute insomnia: a randomized

  2. Clinical Update on Epidemiology, Pathogenesis, and Nonpharmacological Treatment of Insomnia

    Directory of Open Access Journals (Sweden)

    Mustafa Kahriman

    2006-04-01

    Full Text Available Scientific background: Insomnia is by far the most common form of sleep disturbance. Most typically, insomnia has been defined as the symptom of difficulty initiating or maintaining sleep and more rarely as an inability to obtain restorative sleep. Insomnia disorders are most often classified as either primary or secondary to other sleep, psychiatric, or medical conditions, although it is often difficult in practice to determine true causality of insomnia or there may be more than one cause (comorbid conditions. Increasing age, female sex, and psychiatric and medical disorders are consistent risk factors for insomnia. Insomnia is associated with significant social, medical, and financial consequences including impaired social functioning and quality of life, increased risk for psychiatric disorders, and increased health care costs. The clinical assessment of insomnia is based on a careful clinical interview, often supplemented by sleep questionnaires, sleep logs, and psychological testing. Polysomnography is indicated only in selected cases when specific sleep pathologies are suspected. Assessment: A large proportion of insomnia sufferers go undiagnosed, and therefore untreated, by their doctors, and many of these patients incur considerable personal, vocational, and health-related consequences as a result. Insomnia can be triggered by a variety of precipitating events, but when it becomes a chronic problem, psychological and behavioral factors are almost always involved in perpetuating or exacerbating sleep disturbances over time. Psychological and behavioral therapies for primary insomnia include sleep restriction, stimulus control therapy, relaxation training, cognitive strategies, and a combination of those methods, referred to as cognitive behavior therapy of insomnia. Results of the controlled clinical trials indicate that 70% to 80% of patients with primary insomnia partially benefit from cognitive behavior therapy. Although only 20% to

  3. Hypocretin antagonists in insomnia treatment and beyond.

    Science.gov (United States)

    Ruoff, Chad; Cao, Michelle; Guilleminault, Christian

    2011-01-01

    Hypocretin neuropeptides have been shown to regulate transitions between wakefulness and sleep through stabilization of sleep promoting GABAergic and wake promoting cholinergic/monoaminergic neural pathways. Hypocretin also influences other physiologic processes such as metabolism, appetite, learning and memory, reward and addiction, and ventilatory drive. The discovery of hypocretin and its effect upon the sleep-wake cycle has led to the development of a new class of pharmacologic agents that antagonize the physiologic effects of hypocretin (i.e. hypocretin antagonists). Further investigation of these agents may lead to novel therapies for insomnia without the side-effect profile of currently available hypnotics (e.g. impaired cognition, confusional arousals, and motor balance difficulties). However, antagonizing a system that regulates the sleep-wake cycle while also influencing non-sleep physiologic processes may create an entirely different but equally concerning side-effect profile such as transient loss of muscle tone (i.e. cataplexy) and a dampened respiratory drive. In this review, we will discuss the discovery of hypocretin and its receptors, hypocretin and the sleep-wake cycle, hypocretin antagonists in the treatment of insomnia, and other implicated functions of the hypocretin system.

  4. Reducing dysfunctional beliefs about sleep does not significantly improve insomnia in cognitive behavioral therapy.

    Science.gov (United States)

    Okajima, Isa; Nakajima, Shun; Ochi, Moeko; Inoue, Yuichi

    2014-01-01

    The present study examined to examine whether improvement of insomnia is mediated by a reduction in sleep-related dysfunctional beliefs through cognitive behavioral therapy for insomnia. In total, 64 patients with chronic insomnia received cognitive behavioral therapy for insomnia consisting of 6 biweekly individual treatment sessions of 50 minutes in length. Participants were asked to complete the Athens Insomnia Scale and the Dysfunctional Beliefs and Attitudes about Sleep scale both at the baseline and at the end of treatment. The results showed that although cognitive behavioral therapy for insomnia greatly reduced individuals' scores on both scales, the decrease in dysfunctional beliefs and attitudes about sleep with treatment did not seem to mediate improvement in insomnia. The findings suggest that sleep-related dysfunctional beliefs endorsed by patients with chronic insomnia may be attenuated by cognitive behavioral therapy for insomnia, but changes in such beliefs are not likely to play a crucial role in reducing the severity of insomnia.

  5. Insomnia Symptoms Following Treatment for Comorbid Panic Disorder With Agoraphobia and Generalized Anxiety Disorder.

    Science.gov (United States)

    Cousineau, Héloïse; Marchand, André; Bouchard, Stéphane; Bélanger, Claude; Gosselin, Patrick; Langlois, Frédéric; Labrecque, Joane; Dugas, Michel J; Belleville, Geneviève

    2016-04-01

    Patients with panic disorder with agoraphobia (PDA) or generalized anxiety disorder (GAD) frequently also suffer from insomnia. However, the impact of cognitive-behavioral therapy (CBT) for anxiety disorders on insomnia has been understudied. Furthermore, comorbidity between anxiety disorders is common. Our main objective was to assess the impact of CBT for PDA or GAD on insomnia. In a quasi-experimental design, 86 participants with PDA and GAD received conventional CBT for their primary disorder or combined CBT for both disorders. Overall, CBTs had a significant impact on reducing insomnia symptoms (η = 0.58). However, among people with insomnia at pretest (67%), 33% still had an insomnia diagnosis, and the majority (63%) had clinically significant residual insomnia following treatment. In conclusion, the CBTs had a positive effect on the reduction of insomnia, but a significant proportion of participants still had insomnia problems following treatment. Clinicians should address insomnia during CBT for PDA and GAD.

  6. Prevalence and polysomnographic correlates of insomnia comorbid with medical disorders.

    Science.gov (United States)

    Budhiraja, Rohit; Roth, Thomas; Hudgel, David W; Budhiraja, Pooja; Drake, Christopher L

    2011-07-01

    To determine the prevalence and polysomnographic correlates of insomnia in subjects with self-reported medical disorders. Prospective cross-sectional study. Community-based sample of 3282 men and women aged 18 to 65 years old, with a subset who underwent polysomnography. Self-reported measures of sleep habits and current health, and polysomnographic sleep variables. The prevalence of insomnia was 21.4%. The adjusted odds of insomnia were 2.2 times as high in persons with any medical disorders as in those without medical disorders. Specifically, odds of insomnia were higher in people with heart disease (OR = 1.6 [95% CI: 1.2-23], P = 0.004), hypertension (1.5 [12-18], P insomnia increased with increasing number of medical disorders. However, polysomnographic sleep was not significantly different in persons with or without medical disorders for most disorders assessed. This large population-based study suggests that insomnia is highly prevalent in diverse chronic medical disorders. However, polysomnographic evidence of disturbed sleep is present in only a subset of comorbid insomnia populations.

  7. Hierarchy of insomnia criteria based on daytime consequences.

    Science.gov (United States)

    Ohayon, Maurice M; Riemann, Dieter; Morin, Charles; Reynolds, Charles F

    2012-01-01

    To explore how insomnia symptoms are hierarchically organized in individuals reporting daytime consequences of their sleep disturbances. This is a cross-sectional study conducted in the general population of the states of California, New York, and Texas. The sample included 8937 individuals aged 18 years or older representative of the general population. Telephone interviews on sleep habits and disorders were managed with the Sleep-EVAL expert system and using DSM-IV and ICSD classifications. Insomnia symptoms and global sleep dissatisfaction (GSD) had to occur at least three times per week for at least three months. A total of 26.2% of the sample had a GSD. Individuals with GSD reported at least one insomnia symptom in 73.1% of the cases. The presence of GSD in addition to insomnia symptoms considerably increased the proportion of individuals with daytime consequences related to insomnia. In the classification trees performed, GSD arrived as the first predictor for daytime consequences related to insomnia. The second predictor was nonrestorative sleep followed by difficulty resuming sleep and difficulty initiating sleep. Classification trees are a useful way to hierarchically organize symptoms and to help diagnostic classifications. In this study, GSD was found to be the foremost symptom in identifying individuals with daytime consequences related to insomnia. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. Distinct sensitivity to caffeine-induced insomnia related to age.

    Science.gov (United States)

    Frozi, Júlia; de Carvalho, Hudson W; Ottoni, Gustavo L; Cunha, Rodrigo A; Lara, Diogo R

    2018-01-01

    Caffeine acts by antagonizing the effect of the endogenous homeostatic sleep factor adenosine. In the current study we aimed to evaluate the pattern of caffeine-induced insomnia and its relation to age and sex in a general population sample derived from a web survey. The sample included 75,534 participants (28.1% men) from 18 to 75 years who answered self-report questionnaires by accessing a website in Brazilian Portuguese (BRAINSTEP project). In our sample, 3620 (17.0%) men and 9920 (18.3%) women reported insomnia due to caffeine intake. Caffeine-induced insomnia increased with aging in both men and women. This difference remained after adjusting for sociodemographic, psychiatric and sleep related variables as well as caffeine intake. Women showed higher proportion of caffeine-induced insomnia than men, but this difference did not remain after controlling for covariates. Also, individuals with caffeine-induced insomnia reported poorer sleep quality, higher latency to fall asleep and a higher proportion of psychiatric diagnoses and daily use of hypnotic drugs. In conclusion, our results show an age-associated increase in caffeine-induced insomnia and poorer mental health indicators among people with caffeine-induced insomnia complaints.

  9. Insomnia is Associated with Cortical Hyperarousal as Early as Adolescence.

    Science.gov (United States)

    Fernandez-Mendoza, Julio; Li, Yun; Vgontzas, Alexandros N; Fang, Jidong; Gaines, Jordan; Calhoun, Susan L; Liao, Duanping; Bixler, Edward O

    2016-05-01

    To examine whether insomnia is associated with spectral electroencephalographic (EEG) dynamics in the beta (15-35Hz) range during sleep in an adolescent general population sample. A case-control sample of 44 adolescents from the Penn State Child Cohort underwent a 9-h polysomnography, clinical history and physical examination. We examined low-beta (15-25 Hz) and high-beta (25-35 Hz) relative power at central EEG derivations during sleep onset latency (SOL), sleep onset (SO), non-rapid eye movement (NREM) sleep, and wake after sleep onset (WASO). Compared to controls (n = 21), individuals with insomnia (n = 23) showed increased SOL and WASO and decreased sleep duration and efficiency, while no differences in sleep architecture were found. Insomniacs showed increased low-beta and high-beta relative power during SOL, SO, and NREM sleep as compared to controls. High-beta relative power was greater during all sleep and wake states in insomniacs with short sleep duration as compared to individuals with insomnia with normal sleep duration. Adolescent insomnia is associated with increased beta EEG power during sleep, which suggests that cortical hyperarousal is present in individuals with insomnia as early as adolescence. Interestingly, cortical hyperarousal is greatest in individuals with insomnia with short sleep duration and may explain the sleep complaints of those with normal sleep duration. Disturbed cortical networks may be a shared mechanism putting individuals with insomnia at risk of psychiatric disorders. © 2016 Associated Professional Sleep Societies, LLC.

  10. Quality and readability of online information resources on insomnia.

    Science.gov (United States)

    Ma, Yan; Yang, Albert C; Duan, Ying; Dong, Ming; Yeung, Albert S

    2017-09-01

    The internet is a major source for health information. An increasing number of people, including patients with insomnia, search for remedies online; however, little is known about the quality of such information. This study aimed to evaluate the quality and readability of insomnia-related online information. Google was used as the search engine, and the top websites on insomnia that met the inclusion criteria were evaluated for quality and readability. The analyzed websites belonged to nonprofit, commercial, or academic organizations and institutions such as hospitals and universities. Insomnia-related websites typically included definitions (85%), causes and risk factors (100%), symptoms (95%), and treatment options (90%). Cognitive behavioral therapy for insomnia (CBT-I) was the most commonly recommended approach for insomnia treatment, and sleep drugs are frequently mentioned. The overall quality of the websites on insomnia is moderate, but all the content exceeded the recommended reading ease levels. Concerns that must be addressed to increase the quality and trustworthiness of online health information include sharing metadata, such as authorship, time of creation and last update, and conflicts of interest; providing evidence for reliability; and increasing the readability for a layman audience.

  11. Insomnia: the Sleeping Giant of Pediatric Public Health.

    Science.gov (United States)

    Badin, Emily; Haddad, Cynthia; Shatkin, Jess Parker

    2016-05-01

    Insomnia among children and adolescents is ubiquitous and takes a great toll on youth and their families, impacting academic achievement, mood, social functioning, and a variety of developmental outcomes. Unfortunately, however, pediatric insomnia most often remains unidentified and untreated. When treatment is provided, it is most often in the form of medications, which are not FDA approved for that indication in children and adolescents. A comprehensive literature review was employed to establish the recommendations in this report. This article provides a review of sleep physiology and both current and recommended approaches to assessing and treating pediatric insomnia. Comprehensive assessment, accurate diagnosis, and evidence-based treatment of insomnia is imperative to the healthy development of children and adolescents. While clinicians often prescribe a variety of medications to treat pediatric insomnia, there is insufficient data to demonstrate efficacy and endorse their routine use. At this time, behavioral techniques, such as cognitive behavior therapy for insomnia and sleep hygiene education, should remain the first line of treatment. As a second-line consideration, melatonin, a dietary supplement, may be effective. Pediatric insomnia has an enormous impact on children, adolescents, and their families that requires adequate attention from clinicians and parents alike.

  12. Reducing Dysfunctional Beliefs about Sleep Does Not Significantly Improve Insomnia in Cognitive Behavioral Therapy

    OpenAIRE

    Okajima, Isa; Nakajima, Shun; Ochi, Moeko; Inoue, Yuichi

    2014-01-01

    The present study examined to examine whether improvement of insomnia is mediated by a reduction in sleep-related dysfunctional beliefs through cognitive behavioral therapy for insomnia. In total, 64 patients with chronic insomnia received cognitive behavioral therapy for insomnia consisting of 6 biweekly individual treatment sessions of 50 minutes in length. Participants were asked to complete the Athens Insomnia Scale and the Dysfunctional Beliefs and Attitudes about Sleep scale both at the...

  13. Insomnia and limb pain in hemodialysis patients: What is the share of restless leg syndrome?

    OpenAIRE

    Majid Malaki; Fakhr Sadat Mortazavi; Sussan Moazemi; Maryam Shoaran

    2012-01-01

    Insomnia and limb pain are common problems in dialysis patients. In addition, restless leg syndrome (RLS) as a specific cause of insomnia and limb pain has been reported in many studies. The purpose of this study was to estimate incidence of insomnia and RLS as a cause of insomnia in these patients. Twenty-six patients undergoing hemodialysis were investigated for insomnia, limb pain and RLS as per the defined criteria. They were evaluated for dialysis quality, dialysis duration, hemoglobin, ...

  14. Molecular mechanisms of the sleep wake cycle : therapeutic applications to insomnia

    OpenAIRE

    Grima, Melanie; Hunter, Therese; Zhang, Yimeng

    2017-01-01

    The aim of this review is to explore the molecular mechanism and genetic components of the sleepwake cycle and insomnia. Moreover, we wanted to review the correlation between primary insomnia and its comorbidities. With this aim, a systematic review of recent evidence of the molecular and genetic mechanisms involved in the causation of primary insomnia, along with associations between primary insomnia and other diseases were conducted. Primary insomnia is a complex disorder which accounts for...

  15. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    Science.gov (United States)

    Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

    2014-01-01

    Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

  16. Wake up to insomnia: future approaches to the management of insomnia

    Directory of Open Access Journals (Sweden)

    Mohammad Tahir Hussain

    2011-01-01

    Full Text Available Mohammad Tahir Hussain, Steven A. SheaDivision of Sleep Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USAInsomnia is rife. Acutely, almost every individual has experienced a poor night’s sleep, and many short-term remedies for insomnia are tried, including over-the-counter sleep aids and alcohol. Chronic insomnia is the most common sleep disorder, affecting nearly 40 million Americans and accounting for nearly one-third of adults. The annual cost associated with this disorder in the US is estimated at over $15 billionand over $100 billion for indirect costs, such as costs of self-medication, health care-related costs due to exacerbations of comorbid conditions, and costs of reduced productivity.  

  17. European guideline for the diagnosis and treatment of insomnia

    DEFF Research Database (Denmark)

    Riemann, Dieter; Baglioni, Chiara; Bassetti, Claudio

    2017-01-01

    ) system was used to grade the evidence and guide recommendations. The diagnostic procedure for insomnia, and its co-morbidities, should include a clinical interview consisting of a sleep history (sleep habits, sleep environment, work schedules, circadian factors), the use of sleep questionnaires and sleep......-low-quality evidence). Light therapy and exercise need to be further evaluated to judge their usefulness in the treatment of insomnia (weak recommendation, low-quality evidence). Complementary and alternative treatments (e.g. homeopathy, acupuncture) are not recommended for insomnia treatment (weak recommendation...

  18. The Experience of Chronic Insomnia in Chinese Adults: A Study Using Focus Groups and Insomnia Experience Diaries.

    Science.gov (United States)

    Yung, Kam-Ping; Chung, Ka-Fai; Ho, Fiona Yan-Yee; Yeung, Wing-Fai; Ng, Tommy Ho-Yee

    2016-01-01

    The subjective experience in 43 Chinese adults with chronic primary insomnia was assessed using focus groups and insomnia experience diaries. Participants recruited from the community and a sleep clinic were diagnosed with DSM-IV-TR insomnia disorder and had sleep difficulties on 3 or more nights per week for at least 6 months. Six focus groups, of 6-8 participants each, were conducted; it was stopped as thematic saturation emerged in the last 2 groups. Using grounded theory approach, we identified 4 themes and 16 subthemes, covering beliefs about the nature and treatment of insomnia, behavioral responses to insomnia, cognitive-emotional and physiological arousal, and emotional experiences associated with insomnia. The findings are in general compatible with qualitative studies in the West, but some subthemes are influenced by Chinese cultural beliefs and values, in particular, use of the traditional Chinese medicine concept, being modest in sleep expectation, and a letting go attitude. Strategies for cultural adaptation of cognitive-behavioral therapy for insomnia in a Chinese society using patients' subjective experience are discussed.

  19. Hypnotic effects of a novel anti-insomnia formula on Drosophila insomnia model.

    Science.gov (United States)

    Ko, Chun-Hay; Koon, Chi-Man; Yu, Siu-Lung; Lee, Kwok-Ying; Lau, Clara Bik-San; Chan, Edwin Ho-Yin; Wing, Yun-Kwok; Fung, Kwok-Pui; Leung, Ping-Chung

    2016-05-01

    To assess the biological effects of the six-herb mixture Anti-Insomia Formula (AIF) extract using caffeine-induced insomnia Drosophila model and short-sleep mutants. Caffeineinduced insomnia wild-type Drosophila and short-sleep mutant flies minisleep (mns) and Hyperkinetic(Y) (Hk(Y)) were used to assess the hypnotic effects of the AIF in vivo. The night time activity, the amount of night time sleep and the number of sleep bouts were determined using Drosophila activity monitoring system. Sleep was defined as any period of uninterrupted behavioral immobility (0 count per minute) lasting > 5 min. Night time sleep was calculated by summing up the sleep time in the dark period. Number of sleep bouts was calculated by counting the number of sleep episodes in the dark period. AIF at the dosage of 50 mg/mL, effectively attenuated caffeine-induced wakefulness (Psleep bouts, night time activities and increase of the amount of night time sleep. AIF also significantly reduced sleeping time of short-sleep Hk(Y) mutant flies (Psleep quality in insomnia.

  20. Validation of the Athens Insomnia Scale for screening insomnia in South Korean firefighters and rescue workers.

    Science.gov (United States)

    Jeong, Hyeonseok S; Jeon, Yujin; Ma, Jiyoung; Choi, Yera; Ban, Soonhyun; Lee, Sooyeon; Lee, Bora; Im, Jooyeon Jamie; Yoon, Sujung; Kim, Jieun E; Lim, Jae-Ho; Lyoo, In Kyoon

    2015-10-01

    Sleep problems are a major cause of occupational stress in firefighters and rescue workers. We evaluated the psychometric properties of the Athens Insomnia Scale (AIS) among South Korean firefighters and rescue workers. Structured clinical interviews and self-report questionnaires were administered to 221 firefighters and rescue workers. The Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), Short-Form 36-item Health Survey (SF36), and Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) were used to examine convergent and divergent validity. Test-retest reliability was calculated from a subsample (n = 24). Analysis of internal consistency, factor analysis, and receiver operator characteristic curve analysis were conducted. Cronbach's alpha was 0.88. The mean item-total correlation coefficient was 0.73. The test-retest reliability was excellent (ICC = 0.94). Significant correlations of the AIS with the PSQI, ISI, ESS, and SF36 confirmed convergent validity. Nonsignificant associations of the AIS with the AUDIT-C and socioeconomic status showed divergent validity. Factor analysis revealed a one-factor structure. For groups with different symptom severity, group-specific cutoff scores which may improve positive predictive values were suggested. The AIS may be a useful tool with good reliability and validity for screening insomnia symptoms in firefighters and rescue workers.

  1. Prevalence of DSM-IV diagnostic criteria of insomnia: distinguishing insomnia related to mental disorders from sleep disorders.

    Science.gov (United States)

    Ohayon, M M

    1997-01-01

    Epidemiological studies of insomnia in the general population have reported high prevalence rates. However, few have applied diagnostic criteria from existing classification systems. Consequently. It is not possible to determine whether subjects suffered from a sleep disorder or whether the insomnia constituted a symptom of a mental disorder. Insomnia and its relationship with other mental disorders was investigated in the general population using DSM-IV criteria. A representative sample of 5622 subjects from the French population were interviewed about their sleep habits over the telephone by lay interviewers. The course and content of interviews were customized by means of the Sleep-Eval knowledge-based system. A total of 18.6% of the sample reported insomnia complaints. The presence of insomnia complaints, lasting for at least one month with daytime repercussions was found for 12.7% of the sample. Subsequently, subjects were classified according to the Sleep Disorder decision-making process proposed by the DSM-IV classification, but without the recourse of polysomnographic recordings. Specific sleep disorder diagnoses were given for 5.6% of the sample, mostly as insomnia related to another mental disorder, primary insomnia was given for 1.3% of the sample. Primary mental disorder diagnoses were supplied for 8.4% of the sample, mostly as generalized anxiety disorder. The results of this investigation emphasize the need to use classifications to determine whether subjects with insomnia complaints suffer from a sleep disorder or whether insomnia constitutes a symptom of some other mental disorder. These distinctions are of utmost importance as they have a bearing on the choice of treatment. Conversely, diagnoses were obtained by lay interviews, which may have caused a lack of recognition and/or discrimination for light or borderline symptomatology.

  2. Alzheimer's Disease: Aging, Insomnia and Epigenetics

    Directory of Open Access Journals (Sweden)

    Tzong Yuan Wu

    2010-12-01

    Full Text Available Alzheimer's disease (AD is the most common form of dementia. Severe memory loss, confusion, and impaired cognitive abilities characterize AD. It was only a century after Alzheimer's discovery that scientists were able to shed light on the mystery of its cause, but AD has also become a globally important health issue and the treatment of AD is a challenge for modern medicine. At present, there are five drugs approved in the United States for the treatment of AD, namely, donepezil, galantamine, rivastigmine, and tacrine (which are all cholinesterase inhibitors; and memantine (which is a glutamate receptor antagonist. However, these drugs show only modest effects on AD patients. Thus, new investigations are necessary for pharmacological development in AD. This brief review focuses on new studies that demonstrate the link between epigenetics and AD, and explores the possibility that insomnia may be one factor that effects AD.

  3. Epidemiology and management of insomnia in children with autistic spectrum disorders.

    Science.gov (United States)

    Miano, Silvia; Ferri, Raffaele

    2010-04-01

    Insomnia is the predominant sleep concern in children with autistic spectrum disorder (ASD), and its nature is most likely multifactorial, with neurochemical (abnormalities in serotonergic transmission or melatonin levels), psychiatric (anxiety), and behavioral (poor sleep habits) etiological factors involved. Children with ASD experience sleep problems similar to those of typically developing children, although the prevalence is markedly higher, occurring in 44-83% of school-aged children with ASD. Caregivers usually report that insomnia is the most frequent sleep disorder, described as disorders of initiating and maintaining sleep, restless sleep, bedtime resistance, co-sleeping, alterations of sleep hygiene, and early awakenings in the morning. Many actigraphic studies have added information on sleep disorders, confirming the questionnaire findings in the majority of cases. There are relatively few polysomnographic data for ASD, compared with questionnaire studies, and most of these studies reported a reduction in total sleep time and more undifferentiated sleep in the youngest patients. These findings were associated with several sleep microstructure alterations during rapid eye movement (REM) sleep, and with non-REM (NREM) sleep microstructure changes that appeared to be related to cognitive impairment rather than to the autistic core. Moreover, few data about other less frequent sleep disorders, such as periodic limb movements disorder and obstructive sleep apnea syndrome, bruxism, and the influence of epilepsy and EEG abnormalities, are available. Both pharmacologic and behavioral interventions have been suggested for the treatment of sleep problems in autistic children. The most common types of behavioral interventions are complete extinction (removing reinforcement to reduce a behavior) and various forms of graduated extinction. Melatonin has shown promising results in the treatment of insomnia in children with ASD. Although controlled studies are limited

  4. Treating primary insomnia - the efficacy of valerian and hops.

    Science.gov (United States)

    Salter, Shanah; Brownie, Sonya

    2010-06-01

    To evaluate the efficacy of valerian and hops in the treatment of primary insomnia. The AMED and MEDLINE databases were searched for primary sources of literature published between 1950 and 2009, using keywords: herbal medicine, medicinal plants, herbal, Valeriana officinalis, valerian, Humulus lupulus, hops, sleep, insomnia. Studies were included if they evaluated the efficacy of valerian or hops in improving primary insomnia in adults: sixteen studies met the inclusion criteria. Twelve of these found that the use of valerian, on its own, or in combination with hops, is associated with improvements in some sleep parameters (eg. sleep latency and quality of sleep). However, these results need to be interpreted cautiously as there were significant differences in design between the studies. Further randomised, double blind, placebo controlled trials are needed before such herbal treatments can be confidently recommended for the treatment of primary insomnia.

  5. The role of hypnosis and related techniques in insomnia

    Directory of Open Access Journals (Sweden)

    Serban Ionela Lacramioara

    2013-01-01

    Full Text Available Hypnosis is a widespread technique in psychotherapy with applicability in various psychiatric and psychosomatic disorders. Although there are very few studies in this area of research, some results argue in favor of using hypnosis for various sleep disorders. Insomnia is a common health problem, in both primary form and associated with other pathologies, causing a reduction of self-efficiency/cognitive abilities and an overall decreased life quality. Classical psychotropic medication that is commonly used to treat insomnia can cause significant side effects, produce phenomena of dependence and is generally effective only during the period of treatment. Since the current means of pharmacologic treatment for insomnia present significant limitations, especially when treating chronic insomnia, a more suitable alternative could be attained by non-pharmacological approaches such as hypnosis.

  6. Insomnia and sleep disruption: relevance for athletic performance.

    Science.gov (United States)

    Leger, Damien; Metlaine, Arnaud; Choudat, Dominique

    2005-04-01

    Insomnia is a common sleep complaint even in young adults and has important daytime consequences. Several subjective and objective tools are recommended to assess the magnitude of the problem and to try to find a cause. Chronic insomnia is often caused by precipitating factors, such as acute stress, work conditions, illness, and travel, and perpetuating factors, such as poor sleep hygiene, anxiety, and medications. Insomnia may have implications in athletic performance resulting from physical and cognitive effects. Several pharmacologic and nonpharmacologic approaches are employed in the management of insomnia that have proven effective for short-term treatment. The pharmacologic approaches include the use of zolpidem and specific GABA agonists, benzodiazepines for specific indications, antidepressants, and melatonin. The nonpharmacologic approaches include stimulus control, sleep restriction, relaxation strategies, and cognitive behavioral therapy.

  7. Insomnia in central neurologic diseases--occurrence and management

    DEFF Research Database (Denmark)

    Mayer, Geert; Jennum, Poul; Riemann, Dieter

    2011-01-01

    The objective of this review is to highlight the impact of insomnia in central neurological disorders by providing information on its prevalence and give recommendations for diagnosis and treatment. Insomnia in neurological disorders is a frequent, but underestimated symptom. Its occurrence may...... the cause of insomnia must be clearly identified. First line treatment aims at the underlying neurologic disease. The few high quality treatment studies show that short term treatment with hypnotics may be recommended in most disorders after having ruled out high risk for adverse effects. Sedating...... associated with most of the central neurological diseases. The prevalence and treatment of insomnia in neurological diseases still need to be studied in larger patient groups with randomized clinical trials to a) better understand their impact and causal relationship and b) to develop and improve specific...

  8. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    Science.gov (United States)

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  9. Outcomes of Cognitive-Behavioral Treatment for Insomnia on Insomnia, Depression, and Fatigue for Individuals with Multiple Sclerosis: A Case Series

    OpenAIRE

    Clancy, Megan; Drerup, Michelle; Sullivan, Amy Burleson

    2015-01-01

    Background: This clinical case series examined outcomes of cognitive-behavioral therapy for insomnia (CBT-I) in individuals with multiple sclerosis (MS). Current literature links insomnia with higher rates of depression and fatigue in individuals with MS. However, no research to date evaluates a targeted psychotherapeutic intervention for insomnia in this population.

  10. Treatment of Insomnia With Traditional Chinese Herbal Medicine.

    Science.gov (United States)

    Singh, Amrinder; Zhao, Kaicun

    2017-01-01

    Insomnia is a condition with sleep problems and many people suffered from it. Chronic insomnia can last for long time and it will severely affect people's health and the quality of life. In conventional medicine, the most commonly used the medicine is benzodiazepine. It is effective but also has significant side effects. Patients try to use some kinds of alternative medicines. Chinese medicinal herbs and formulas have been used in the treatment of insomnia for more than 2000 years in China. In recent decades, Chinese herbal medicine has been widely used in the Western countries. Many clinical studies including randomized controlled clinical trials and research on pharmacological action mechanisms of the herbs for treatment of insomnia have been conducted. It is very important and very helpful to review the published research papers to gather the available information for a critical analysis. This chapter evaluated the data from both of clinical studies and pharmacological researches on the therapeutic formulas and on some key herbs used in the treatment of insomnia. Clinical studies showed a very wide spectrum of herbs that were used in clinical treatment of insomnia. This was due to different syndrome patterns happened with insomnia. This brought complexity and difficulties to identify which are the essential key herbs or formulas. It was found Suanzaoren decoction (Ziziphus spinose decoction ) is the most frequently used formula for the treatment of insomnia. Based on the clinical data, several herbs were identified as most frequently used sedative and hypnotic herbs in Chinese herbal medicine including Suanzaoren (Ziziphus spinose ), Fuling (Poria cocos ), and Gancao (Glycyrrhiza uralensis ). The underlying pharmacological action mechanisms discovered in the studies on some key herbs used in the treatment of insomnia were evaluated. The major pharmacological action mechanisms shared by most of the sedative herbs are to act through the neurotransmitter gamma

  11. Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

    Science.gov (United States)

    Nawroth, Frank; Tandler-Schneider, Andreas; Bilger, Wilma

    2015-01-01

    This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH) using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI) alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles ≥15 mm). Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population). The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%), 50.0 IU (n=1,056 from N=3,189; 33.1%), and 75.0 IU (n=738 from N=3,189; 23.1%) on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%), 50.0 IU (n=922 from N=3,189; 28.9%), and 75.0 IU (n=895 from N=3,189; 28.1%) on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU) of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. PMID:25926755

  12. Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

    Science.gov (United States)

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Fujii, Shoko; Kakiuchi, Seigo; Fujiwara, Hisataka; Kameda, Hiroyuki; Tamura, Masahiro; Kaku, Kohei

    2017-11-01

    Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  13. A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion.

    Science.gov (United States)

    Barbanti Brodano, G; Griffoni, C; Zanotti, B; Gasbarrini, A; Bandiera, S; Ghermandi, R; Boriani, S

    2015-10-01

    Iliac crest bone graft (ICBG) is considered the gold standard for spine surgical procedures to achieve a successful fusion, because of its known osteoinductive and osteoconductive properties. Considering its autogenous origin, the use of ICBG has not been associated to an increase of intraoperative or postoperative complications directly related to the surgery. However, complications related to the harvesting procedure and to the donor site morbidity have been largely reported in the literature, favoring the development of a wide range of alternative products to be used as bone graft extenders or substitutes for spine fusion. The family of ceramic-based bone grafts has been widely used and studied during the last years for spine surgical procedures in order to reduce the need for iliac crest bone grafting and the consequent morbidity associated to the harvesting procedures. We report here the results of a post-market surveillance analysis performed on four independent cohorts of patients (115 patients) to evaluate the safety of three different formulations of hydroxyapatite-derived products used as bone graft extenders/substitutes for lumbar arthrodesis. No intraoperative or post-operative complications related to the use of hydroxyapatite-derived products were detected, during medium and long follow up period (minimum 12 months-maximum 5 years). This post-market surveillance analysis evidenced the safety of ceramic products as bone graft extenders or substitutes for spine fusion. Moreover, the evidence of the safety of hydroxyapatite-derived products allows to perform clinical studies aimed at evaluating the fusion rates and the clinical outcomes of these materials as bone graft extenders/substitutes, in order to support their use as an alternative to ICBG for spine fusion.

  14. Importance of Contrast Aortography With Lotus Transcatheter Aortic Valve Replacement: A Post Hoc Analysis From the RESPOND Post-Market Study.

    Science.gov (United States)

    van Gils, Lennart; Wöhrle, Jochen; Hildick-Smith, David; Bleiziffer, Sabine; Blackman, Daniel J; Abdel-Wahab, Mohamed; Gerckens, Ulrich; Brecker, Stephen; Bapat, Vinayak; Modine, Thomas; Soliman, Osama I; Nersesov, Andrey; Allocco, Dominic; Falk, Volkmar; Van Mieghem, Nicolas M

    2018-01-22

    The aim of this post hoc analysis from the RESPOND (Repositionable Lotus Valve System-Post-Market Evaluation of Real World Clinical Outcomes) post-market study was to assess the final implantation depth on the contrast aortogram after Lotus valve (Boston Scientific, Marlborough, Massachusetts) transcatheter aortic valve replacement (TAVR) and to correlate with permanent pacemaker implantation (PPI) and paravalvular leak (PVL). Contrast aortography allows for the assessment of implantation depth and PVL during and after TAVR. Previous reports suggested an association between final device position and rates of PPI and PVL. The RESPOND study was a prospective, open-label, single-arm study in 41 centers evaluating outcomes after Lotus TAVR in routine clinical practice. Aortograms were collected at the Erasmus Medical Center and analyzed by researchers who were blinded to clinical outcomes. The primary analysis correlated implantation depth with PPI and PVL and required aortograms in a coaxial projection. The relation between implantation depth and need for PPI was assessed by multivariate logistic regression, adjusting for pre-defined confounders. A secondary analysis compared PVL analysis by contrast aortography with transthoracic echocardiography (TTE) performed by the independent core laboratory. A total of 724 angiographic studies were included in this analysis. Mean Lotus implantation depth was 6.67 ± 2.19 mm. The overall PPI rate was 35%. PPI rate was lower with shallow implants (analysis of the RESPOND study PPI was highly correlated with implantation depth, whereas PVL was not. Higher Lotus implantation may reduce need for PPI. Copyright © 2018. Published by Elsevier Inc.

  15. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER) Database and Association Analysis.

    Science.gov (United States)

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender) has not been proposed. We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA). We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male. Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions differed by gender

  16. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

    Science.gov (United States)

    Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

    2016-02-08

    This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  17. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER Database and Association Analysis.

    Directory of Open Access Journals (Sweden)

    Masakazu Fujiwara

    Full Text Available Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender has not been proposed.We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA. We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male.Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported adverse drug reactions

  18. A randomized controlled trial of mindfulness meditation for chronic insomnia.

    Science.gov (United States)

    Ong, Jason C; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K

    2014-09-01

    To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Three-arm, single-site, randomized controlled trial. Academic medical center. Fifty-four adults with chronic insomnia. Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P Mindfulness meditation appears to be a viable treatment option for adults with chronic insomnia and could provide an alternative to traditional treatments for insomnia. Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781. © 2014 Associated Professional Sleep Societies, LLC.

  19. Insomnia is Associated with Cortical Hyperarousal as Early as Adolescence

    Science.gov (United States)

    Fernandez-Mendoza, Julio; Li, Yun; Vgontzas, Alexandros N.; Fang, Jidong; Gaines, Jordan; Calhoun, Susan L.; Liao, Duanping; Bixler, Edward O.

    2016-01-01

    Study Objectives: To examine whether insomnia is associated with spectral electroencephalographic (EEG) dynamics in the beta (15–35Hz) range during sleep in an adolescent general population sample. Methods: A case-control sample of 44 adolescents from the Penn State Child Cohort underwent a 9-h polysomnography, clinical history and physical examination. We examined low-beta (15–25 Hz) and high-beta (25–35 Hz) relative power at central EEG derivations during sleep onset latency (SOL), sleep onset (SO), non-rapid eye movement (NREM) sleep, and wake after sleep onset (WASO). Results: Compared to controls (n = 21), individuals with insomnia (n = 23) showed increased SOL and WASO and decreased sleep duration and efficiency, while no differences in sleep architecture were found. Insomniacs showed increased low-beta and high-beta relative power during SOL, SO, and NREM sleep as compared to controls. High-beta relative power was greater during all sleep and wake states in insomniacs with short sleep duration as compared to individuals with insomnia with normal sleep duration. Conclusions: Adolescent insomnia is associated with increased beta EEG power during sleep, which suggests that cortical hyperarousal is present in individuals with insomnia as early as adolescence. Interestingly, cortical hyperarousal is greatest in individuals with insomnia with short sleep duration and may explain the sleep complaints of those with normal sleep duration. Disturbed cortical networks may be a shared mechanism putting individuals with insomnia at risk of psychiatric disorders. Citation: Fernandez-Mendoza J, Li Y, Vgontzas AN, Fang J, Gaines J, Calhoun SL, Liao D, Bixler EO. Insomnia is associated with cortical hyperarousal as early as adolescence. SLEEP 2016;39(5):1029–1036. PMID:26951400

  20. Bidirectional associations between insomnia symptoms and unhealthy behaviours.

    Science.gov (United States)

    Haario, Peppi; Rahkonen, Ossi; Laaksonen, Mikko; Lahelma, Eero; Lallukka, Tea

    2013-02-01

    It has been suggested that there are associations among insomnia symptoms and unhealthy behaviours. However, previous studies are sparse and mainly cross-sectional, and have not been focused on several key unhealthy behaviours. The aim of this study was to examine whether the associations are bidirectional, i.e. whether insomnia symptoms are associated with subsequent unhealthy behaviours, and whether unhealthy behaviours are associated with subsequent insomnia symptoms. The data were derived from the Helsinki Health Study prospective cohort study. The baseline data were collected in 2000-02 (n = 8960, response rate 67%) among 40-60-year-old employees of the City Helsinki, Finland. The follow-up data were collected in 2007 (n = 7332, response rate 83%). Logistic regression analysis was used to examine the associations among insomnia symptoms and unhealthy behaviours, including smoking, heavy and binge drinking, physical inactivity and unhealthy food habits. Frequent insomnia symptoms at baseline were associated with subsequent heavy drinking [odds ratio (OR): 1.34; 95% confidence interval (CI): 1.07-1.68] and physical inactivity (OR: 1.27; 95% CI: 1.08-1.48) after full adjustment for gender, age, corresponding unhealthy behaviour at baseline, marital status, occupational class, sleep duration and common mental disorders. Additionally, heavy drinking (OR: 1.48; 95% CI: 1.22-1.80) and binge drinking (OR: 1.26; 95% CI: 1.08-1.46) at baseline were associated with subsequent insomnia symptoms at follow-up after full adjustment. In conclusion, insomnia symptoms were associated with subsequent heavy drinking and physical inactivity, and heavy and binge drinking were also associated with subsequent insomnia symptoms. © 2012 European Sleep Research Society.

  1. People with insomnia: experiences with sedative hypnotics and risk perception

    OpenAIRE

    Cheung, Janet M. Y.; Bartlett, Delwyn J.; Armour, Carol L.; Ellis, Jason G.; Saini, Bandana

    2015-01-01

    Background - Sedative hypnotics form an important part of managing insomnia and are recommended for short-term use. It is standard practice for clinicians to inform the patient to use medications only ‘when required’, but the use of these medications is often chronic. Little is known about the impact of standard labelling/instructions on promoting appropriate medication use for managing insomnia.\\ud \\ud Objective - To explore patient medication-taking beliefs, experiences and behavioural prac...

  2. Is exercise an alternative treatment for chronic insomnia?

    Directory of Open Access Journals (Sweden)

    Giselle Soares Passos

    Full Text Available The purposes of this systematic/critical review are: 1 to identify studies on the effects of exercise on chronic insomnia and sleep complaints in middle-aged and older adults and to compare the results of exercise with those obtained with hypnotic medications and 2 to discuss potential mechanisms by which exercise could promote sleep in insomniac patients. We identified studies from 1983 through 2011 using MEDLINE, SCOPUS and Web of Science. For systematic analyses, only studies assessing the chronic effects of exercise on sleep in people with sleep complaints or chronic insomnia were considered. We used the following keywords when searching for articles: insomnia, sleep, sleep complaints, exercise and physical activity. For a critical review, studies were selected on the effects of exercise and possible mechanisms that may explain the effects of exercise on insomnia. We identified five studies that met our inclusion criteria for systematic review. Exercise training is effective at decreasing sleep complaints and insomnia. Aerobic exercise has been more extensively studied, and its effects are similar to those observed after hypnotic medication use. Mechanisms are proposed to explain the effects of exercise on insomnia. There is additional documented evidence on the antidepressant and anti-anxiety effects of exercise. Exercise is effective to decrease sleep complaints and to treat chronic insomnia. Exercise presented similar results when compared with hypnotics; however, prospective studies comparing the effects of exercise with medical and non-medical treatments are warranted before including exercise as a first-line treatment for chronic insomnia are necessary.

  3. Changes in insomnia subtypes in early Parkinson disease.

    Science.gov (United States)

    Tholfsen, Lena K; Larsen, Jan P; Schulz, Jörn; Tysnes, Ole-Bjørn; Gjerstad, Michaela D

    2017-01-24

    To examine the development of factors associated with insomnia in a cohort of originally drug-naive patients with incident Parkinson disease (PD) during the first 5 years after diagnosis. One hundred eighty-two drug-naive patients with PD derived from a population-based incident cohort and 202 control participants were assessed for insomnia before treatment initiation and were repeatedly examined after 1, 3, and 5 years. Insomnia was diagnosed according to the Stavanger Sleepiness Questionnaire. The Parkinson's Disease Sleep Scale was used to differentiate sleep initiation problems from problems of sleep maintenance. Generalized estimating equation models were applied for statistical measures. The prevalence of insomnia in general was not higher in patients with PD compared to controls at the 5-year follow-up. There were changes in the prevalence of the different insomnia subtypes over the 5-year follow-up. The prevalence of solitary problems in sleep maintenance increased from 31% (n = 18) in the drug-naive patients at baseline to 49% (n = 29) after 1 year and were associated with the use of dopamine agonists and higher Montgomery-Åsberg Depression Rating Scale scores. The prevalence of solitary sleep initiation problems decreased continuously from 21% (n = 12) at baseline to 7.4% (n = 4) after 5 years; these were associated with less daytime sleepiness. The prevalence rates of the different insomnia subtypes changed notably in patients with early PD. The frequency of sleep maintenance problems increased, and these problems were associated with dopamine agonist use and depressive symptoms, while the total number of patients with insomnia remained stable. Our findings reflect the need for early individual assessments of insomnia subtypes and raise the possibility of intervention to reduce these symptoms in patients with early PD. © 2016 American Academy of Neurology.

  4. [Effectiveness of an online cognitive behavioral therapy for insomnia].

    Science.gov (United States)

    Friðgeirsdóttir, Guðlaug; Jóhannsson, Gunnar; Ellertsson, Steindór; Björnsdóttir, Erla

    2015-04-01

    Insomnia is a common health problem with serious mental and physical consequences as well as increased economical costs. The use of hypnotics in Iceland is immense in spite of cognitive behavioral therapy for insomnia (CBT-I) being recommended as the first choice treatment of chronic insomnia. To meet the needs of more individuals suffering from insomnia, online CBT-I was established at betrisvefn.is. The objective of this research was to evaluate the effectiveness of this internet-based CBT-I. One hundred seventy-five users (mean age 46 y (18-79 y)) started a 6 week online intervention for insomnia. The drop-out rate was 29%, leaving a final sample of 125 users. The intervention is based on well-established face-to-face CBT-I. Sleep diaries were used to determine changes in sleep efficiency, sleep onset latency and wake after sleep onset. Treatment effects were assesed after 6 weeks of treatment and at the 6 week follow-up. Significant improvement was found in all main sleep variables except for 5% decrease in total sleep time (TST). Effects were sustained at 6 week follow-up and TST increased. The use of hypnotics decreased significantly. This form of treatment seems to suit its users very well and over 94% would recommend the treatment. Internet interventions for insomnia seem to have good potential. CBT-I will hopefully be offered as the first line treatment for chronic insomnia in Iceland instead of hypnotics as the availability of the CBT-I is growing. Thus, the burden on health care clinics might reduce along with the hypnotics use and the considerable costs of insomnia.

  5. Subjective daytime functioning assessment in people with insomnia.

    Science.gov (United States)

    Grabowski, Karol; Nowicka-Sauer, Katarzyna; Zdrojewski, Tomasz; Rutkowski, Marcin; Bandosz, Piotr; Nowicki, Zbigniew

    2017-10-29

    The aim of this study was to assess the prevalence and severity of subjective daytime functioning impairment among people with insomnia complaints. Another goal was to establish its relationships with age, gender, type and duration of subjective insomnia. Study group consisted of NATPOL study participants - 2,413 people (1,245 women and 1,168 men) aged 18-79. We extracted group with declared insomnia complaints, consisting of 1,221 people (736 women and 485 men) aged 18-79. Data on insomnia symptoms characteristics, their duration and subjective functioning impairment were further analyzed. Functioning impairment was declared by 825 people (67.7% of those who declared subjective insomnia) and it was more common in women. It was most common among people with insomnia complaints lasting over two weeks - 72.4%. In people with symptoms lasting less than two weeks or for a few days it was 70.7% and 64.9% respectively. People with insomnia symptoms lasting over two weeks accounted for 20% of group with severe functioning impairment. For shorter duration of symptoms it was 8.6% and 6.9% respectively. Among people with mild functioning impairment, persons with symptoms lasting for a few days and less than two weeks were predominant - 32.5% and 35.3% respectively. In people aged 18-24 years mild functioning impairment was predominant (66.66%). Subjective daytime functioning impairment is common in people declaring insomnia symptoms. It is more common in women and its prevalence and intensity are greater in people with longer duration of sleep problems. Its prevalence is not correlated with age and it is the mildest in people aged 18-24.

  6. Insomnia symptoms in older adults: associated factors and gender differences.

    OpenAIRE

    Jaussent, Isabelle; Dauvilliers, Yves; Ancelin, Marie-Laure; Dartigues, Jean-François; Tavernier, Béatrice; Touchon, Jacques; Ritchie, Karen,; Besset, Alain

    2011-01-01

    International audience; OBJECTIVES: the aim of this study was to examine the factors associated with insomnia in community-dwelling elderly as a function of the nature and number of insomnia symptoms (IS), e.g., difficulty with initiating sleep (DIS), difficulty with maintaining sleep (DMS), and early morning awakening (EMA). METHODS: is were assessed in a sample of 2,673 men and 3,213 women aged 65 years and older. The participants were administered standardized questionnaires regarding the ...

  7. Insomnia in central neurologic diseases--occurrence and management.

    Science.gov (United States)

    Mayer, Geert; Jennum, Poul; Riemann, Dieter; Dauvilliers, Yves

    2011-12-01

    The objective of this review is to highlight the impact of insomnia in central neurological disorders by providing information on its prevalence and give recommendations for diagnosis and treatment. Insomnia in neurological disorders is a frequent, but underestimated symptom. Its occurrence may be a direct consequence of the disease itself or may be secondary to pain, depression, other sleep disorders or the effects of medications. Insomnia can have a significant impact on the patient's cognitive and physical function and may be associated with psychological distress and depression. Diagnosis of insomnia is primarily based on medical history and validated questionnaires. Actigraphy is a helpful diagnostic tool for assessing the circadian sleep-wake rhythm. For differential diagnosis and to measure the duration of sleep full polysomnography may be recommended. Prior to initiating treatment the cause of insomnia must be clearly identified. First line treatment aims at the underlying neurologic disease. The few high quality treatment studies show that short term treatment with hypnotics may be recommended in most disorders after having ruled out high risk for adverse effects. Sedating antidepressants may be an effective treatment for insomnia in stroke and Parkinson's disease (PD) patients. Melatonin and light treatment can stabilize the sleep-wake circadian rhythm and shorten sleep latency in dementias and PD. Cognitive behavioral therapy (CBT) can be effective in treating insomnia symptoms associated with most of the central neurological diseases. The prevalence and treatment of insomnia in neurological diseases still need to be studied in larger patient groups with randomized clinical trials to a) better understand their impact and causal relationship and b) to develop and improve specific evidence-based treatment strategies. Copyright © 2011 Elsevier Ltd. All rights reserved.

  8. Stress and sleep reactivity: a prospective investigation of the stress-diathesis model of insomnia.

    Science.gov (United States)

    Drake, Christopher L; Pillai, Vivek; Roth, Thomas

    2014-08-01

    To prospectively assess sleep reactivity as a diathesis of insomnia, and to delineate the interaction between this diathesis and naturalistic stress in the development of insomnia among normal sleepers. Longitudinal. Community-based. 2,316 adults from the Evolution of Pathways to Insomnia Cohort (EPIC) with no history of insomnia or depression (46.8 ± 13.2 y; 60% female). None. Participants reported the number of stressful events they encountered at baseline (Time 1), as well as the level of cognitive intrusion they experienced in response to each stressor. Stressful events (OR = 1.13; P insomnia one year hence (Time 2). Intrusion mediated the effects of stressful events on risk for insomnia (P insomnia (OR = 1.78; P insomnia as a function of intrusion was significantly higher in individuals with high sleep reactivity. Trait sleep reactivity also constituted a significant risk for depression (OR = 1.67; P Insomnia at Time 2 significantly mediated this effect (P insomnia, and that it triggers insomnia by exacerbating the effects of stress-induced intrusion. Sleep reactivity is also a precipitant of depression, as mediated by insomnia. These findings support the stress-diathesis model of insomnia, while highlighting sleep reactivity as an important diathesis. Drake CL, Pillai V, Roth T. Stress and sleep reactivity: a prospective investigation of the stress-diathesis model of insomnia.

  9. Associations of nonrestorative sleep with insomnia, depression, and daytime function.

    Science.gov (United States)

    Sarsour, Khaled; Van Brunt, David L; Johnston, Joseph A; Foley, Kathleen A; Morin, Charles M; Walsh, James K

    2010-12-01

    Nonrestorative sleep (NRS) complaints are common but associations with insomnia, daytime function or depressive symptoms are not well-established. This study aims to (1) describe insomnia related symptoms and sleep quality in those with NRS compared to those with no NRS; (2) identify the independent associations between NRS, insomnia severity, and depression; and (3) identify the association between NRS and daytime function independent of insomnia severity and depression. Cross sectional survey of enrollees at a health plan in the Midwestern United States. Respondents were surveyed about the presence and frequency of NRS complaints, depression, insomnia severity and related symptoms. Multivariate regression was used to examine the study's three research aims. Study sample consisted of 541 subjects with NRS and 717 who reported never experiencing any NRS symptoms. We found a statistically significant interaction between NRS and total sleep duration such that the association between sleep duration and sleep quality was attenuated in those with NRS compared to those without NRS (b=-0.26, SE=0.07, pfunction, cognitive function and emotional function OR [95%CI]=2.21 [1.59-3.08], 1.90 [1.37-2.64] and 1.71 [1.23-2.36], respectively. NRS is a complex concept that should be further defined and studied in the larger context of sleep quality, other insomnia related symptoms, daytime function and depression. Copyright © 2010 Elsevier B.V. All rights reserved.

  10. Sleep, insomnia, and hypertension: current findings and future directions.

    Science.gov (United States)

    Thomas, S Justin; Calhoun, David

    2017-02-01

    Blood pressure (BP) varies over 24 hours. During normal sleep, BP typically decreases by 10% or more. Research suggests that disordered sleep, particularly sleep deprivation and obstructive sleep apnea, is associated with increased BP and risk of hypertension. Less is known about the relationship between insomnia and hypertension. Population-based studies have reported an association between insomnia symptoms and both prevalent and incident hypertension, particularly in the context of short sleep duration. Furthermore, a number of mechanisms have been proposed to explain the relationship between insomnia and hypertension. However, few studies have examined these proposed mechanisms, and even fewer clinical trials have been conducted to determine if improved sleep improves BP and/or reverses a nondipping BP pattern. Methodological concerns, particularly with respect to the diagnosis of insomnia, no doubt impact the strength of any observed association. Additionally, a large majority of studies have only examined the association between insomnia symptoms and clinic BP. Therefore, future research needs to focus on careful consideration of the diagnostic criteria for insomnia, as well as inclusion of either home BP or ambulatory BP monitoring. Finally, clinical trials aimed at improving the quality of sleep should be conducted to determine if improved sleep impacts 24-hour BP. Copyright © 2016 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

  11. Assessing cognitive processes related to insomnia: A review and measurement guide for Harvey's cognitive model for the maintenance of insomnia.

    Science.gov (United States)

    Hiller, Rachel M; Johnston, Anna; Dohnt, Hayley; Lovato, Nicole; Gradisar, Michael

    2015-10-01

    Cognitive processes play an important role in the maintenance, and treatment of sleep difficulties, including insomnia. In 2002, a comprehensive model was proposed by Harvey. Since its inception the model has received >300 citations, and provided researchers and clinicians with a framework for understanding and treating insomnia. The aim of this review is two-fold. First, we review the current literature investigating each factor proposed in Harvey's cognitive model of insomnia. Second, we summarise the psychometric properties of key measures used to assess the model's factors and mechanisms. From these aims, we demonstrate both strengths and limitations of the current knowledge of appropriate measurements associated with the model. This review aims to stimulate and guide future research in this area; and provide an understanding of the resources available to measure, target, and resolve cognitive factors that may maintain chronic insomnia. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Association between report of insomnia and daytime functioning.

    Science.gov (United States)

    Ustinov, Yuriy; Lichstein, Kenneth L; Wal, Gregory S Vander; Taylor, Daniel J; Riedel, Brant W; Bush, Andrew J

    2010-01-01

    The relationship between reports of insomnia and daytime functioning was investigated using hierarchical regression. The presence or absence of a report of insomnia was the predictor of primary interest. A number of covariates were included in the model: demographic variables, health variables, and quantitative sleep parameters. Data were collected from a community sample in the Memphis, Tennessee area. Data from 734 volunteers, ranging in age from 20 to 96years were analyzed. The sample included 235 individuals who reported having chronic insomnia and 499 individuals who reported no sleep problems. Participants completed a 2-week sleep diary, a battery of daytime functioning questionnaires, and a medical disorders checklist. Demographic information was also collected. The daytime functioning assessment included the Beck Depression Inventory, the State-Trait Anxiety Inventory, the Epworth Sleepiness Scale, the Insomnia Impact Scale, and the Fatigue Severity Scale. The hierarchical regression model included four sets. The first three sets consisted of 18 variables capturing demographic, health, and sleep diary parameters. The fourth set included a single dichotomous variable representing the presence or absence of a report of insomnia. Reports of insomnia were a significant predictor of all five daytime functioning measures, which is consistent with previous research. We also showed that reports of insomnia were able to uniquely explain a significant amount of variability in self-reported daytime functioning after controlling for demographics, health, and sleep diary variables. The pattern of individual variables that reached significance in the first three sets varied depending on which daytime functioning measure was predicted, however, age, the presence of pain, the presence of mental health problems, SOL, and WASO were the most commonly significant predictors of poor daytime functioning from these sets across measures. Individuals' perceptions of their sleep are

  13. Cognitive Behavioral Insomnia Therapy for Those With Insomnia and Depression: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Carney, Colleen E; Edinger, Jack D; Kuchibhatla, Maragatha; Lachowski, Angela M; Bogouslavsky, Olya; Krystal, Andrew D; Shapiro, Colin M

    2017-04-01

    To compare cognitive behavioral therapy for insomnia (CBT-I) + antidepressant medication (AD) against treatments that target solely depression or solely insomnia. A blinded, randomized split-plot experimental study. Two urban academic clinical centers. 107 participants (68% female, mean age 42 ± 11) with major depressive disorder and insomnia. Randomization was to one of three groups: antidepressant (AD; escitalopram) + CBT-I (4 sessions), CBT-I + placebo pill, or AD + 4-session sleep hygiene control (SH). Subjective sleep was assessed via 2 weeks of daily sleep diaries (use of medication was covaried in all analyses); although there were no statistically significant group differences detected, all groups improved from baseline to posttreatment on subjective sleep efficiency (SE) and total wake time (TWT) and the effect sizes were large. Objective sleep was assessed via overnight polysomnographic monitoring at baseline and posttreatment; analyses revealed both CBT groups improved on TWT (p = .03), but the AD + SH group worsened. There was no statistically significant effect for PSG SE (p = .07). There was a between groups medium effect observed for the AD + SH and CBT + placebo group differences on diary TWT and both PSG variables. All groups improved significantly from baseline to posttreatment on the Hamilton Rating Scale for Depression (HAMD-17); the groups did not differ. Although all groups self-reported sleeping better after treatment, only the CBT-I groups improved on objective sleep, and AD + SH's sleep worsened. This suggests that we should be treating sleep in those with depression with an effective insomnia treatment and relying on self-report obscures sleep worsening effects. All groups improved on depression, even a group with absolutely no depression-focused treatment component (CBT-I + placebo). The depression effect in CBT-I only group has been reported in other studies, suggesting that we should further investigate the antidepressant properties of

  14. Insomnia and limb pain in hemodialysis patients: What is the share of restless leg syndrome?

    Directory of Open Access Journals (Sweden)

    Majid Malaki

    2012-01-01

    Full Text Available Insomnia and limb pain are common problems in dialysis patients. In addition, restless leg syndrome (RLS as a specific cause of insomnia and limb pain has been reported in many studies. The purpose of this study was to estimate incidence of insomnia and RLS as a cause of insomnia in these patients. Twenty-six patients undergoing hemodialysis were investigated for insomnia, limb pain and RLS as per the defined criteria. They were evaluated for dialysis quality, dialysis duration, hemoglobin, serum phosphorous, ionized calcium, iron and ferritin levels. These variables between patients with insomnia and those with normal sleep were evaluated by independent "t" test. Without considering the etiology or pathogenesis of insomnia, we evaluated the occurrence of insomnia and limb pain in these patients, and specifically, restless leg syndrome. Insomnia and limb pain were common in dialytic patients. 46% of patients had insomnia. 91% of sleepless group had limb pain as a persistent, annoying complaint. Limb pain was not seen in groups with a normal sleep pattern. Restless leg syndrome was found in 8% of total cases (2 out of 26 and 17% among the insomnia group (2 out of 12. In spite of high incidence of insomnia among patients undergoing regular hemodialysis, role of RLS is trivial. There is a strong relationship between hemoglobin levels and duration of renal replacement therapy to insomnia occurrence.

  15. Insomnia and limb pain in hemodialysis patients: what is the share of restless leg syndrome?

    Science.gov (United States)

    Malaki, Majid; Mortazavi, Fakhr Sadat; Moazemi, Sussan; Shoaran, Maryam

    2012-01-01

    Insomnia and limb pain are common problems in dialysis patients. In addition, restless leg syndrome (RLS) as a specific cause of insomnia and limb pain has been reported in many studies. The purpose of this study was to estimate incidence of insomnia and RLS as a cause of insomnia in these patients. Twenty-six patients undergoing hemodialysis were investigated for insomnia, limb pain and RLS as per the defined criteria. They were evaluated for dialysis quality, dialysis duration, hemoglobin, serum phosphorous, ionized calcium, iron and ferritin levels. These variables between patients with insomnia and those with normal sleep were evaluated by independent "t" test. Without considering the etiology or pathogenesis of insomnia, we evaluated the occurrence of insomnia and limb pain in these patients, and specifically, restless leg syndrome. Insomnia and limb pain were common in dialytic patients. 46% of patients had insomnia. 91% of sleepless group had limb pain as a persistent, annoying complaint. Limb pain was not seen in groups with a normal sleep pattern. Restless leg syndrome was found in 8% of total cases (2 out of 26) and 17% among the insomnia group (2 out of 12). In spite of high incidence of insomnia among patients undergoing regular hemodialysis, role of RLS is trivial. There is a strong relationship between hemoglobin levels and duration of renal replacement therapy to insomnia occurrence.

  16. People with insomnia: experiences with sedative hypnotics and risk perception.

    Science.gov (United States)

    Cheung, Janet M Y; Bartlett, Delwyn J; Armour, Carol L; Ellis, Jason G; Saini, Bandana

    2016-08-01

    Sedative hypnotics form an important part of managing insomnia and are recommended for short-term use. It is standard practice for clinicians to inform the patient to use medications only 'when required', but the use of these medications is often chronic. Little is known about the impact of standard labelling/instructions on promoting appropriate medication use for managing insomnia. To explore patient medication-taking beliefs, experiences and behavioural practices relating to the use of pharmacological/complementary sleep aids for insomnia. Specialist sleep/psychology clinics and the general community in Sydney, Australia. Semi-structured interviews were conducted with 51 people with insomnia using a schedule of questions to gauge their experiences, beliefs and current practices relating to insomnia medication use. Interviews were audio-recorded, transcribed verbatim and subjected to Framework Analysis to identify emergent themes. Participants held distinctive views about the safety and efficacy of complementary and pharmacological agents but do not intuitively turn to medications to resolve their sleep complaint. Medication use was affirmed through tangible medication-taking cues due to the ambivalence in current instructions and labelling. Practices such as dosage modification, medication substitution and delaying medication use might be important drivers for psychological dependence. Current labelling and instructions do not necessarily promote the quality use of sedative hypnotics due to the variability in patient interpretations. Clarifying the timing, quantity and frequency of medication administration as well as insomnia symptom recognition would play a significant role in optimizing the role of pharmacotherapy in the management of insomnia. © 2015 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

  17. Sleep apnea in patients reporting insomnia or restless legs symptoms.

    Science.gov (United States)

    Bianchi, M T; Goparaju, B; Moro, M

    2016-01-01

    Insomnia and restless legs syndrome (RLS) are defined by self-reported symptoms, and polysomnography (PSG) is not routinely indicated. Occult obstructive sleep apnea (OSA), common even in asymptomatic adults, may complicate management of patients presenting with insomnia or restless legs. To this end, we investigated objective sleep apnea metrics in a large retrospective cohort according to self-reported symptom profiles. We compared sleep apnea findings in patients referred to our center according to self-reported symptoms associated with insomnia, sleep apnea, and restless legs. The cohort included over 1900 adults who underwent diagnostic (n = 1418) or split-night (n = 504) PSGs and completed a symptom and medical history questionnaire. More than 30% of patients who did not endorse any OSA symptoms, but did endorse insomnia or restless legs symptoms, were found to have OSA based on apnea-hypopnea index (AHI) >5 during overnight laboratory testing. Regression models of the full cohort showed that the risk of OSA was related, as expected, to older age, male sex, elevated body mass index, and presence of OSA symptoms. The presence of insomnia symptoms did not alter the risk of OSA. The presence of restless legs symptoms showed a small odds ratio for lowered OSA risk. Objective evidence of OSA occurs similarly in those with insomnia or restless legs symptoms, even among those without self-reported OSA symptoms. Providers should be aware of the potential for occult OSA in populations with insomnia and restless legs, which may complicate their management in addition to presenting an independent medical risk itself. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Insomnia with physiological hyperarousal is associated with hypertension.

    Science.gov (United States)

    Li, Yun; Vgontzas, Alexandros N; Fernandez-Mendoza, Julio; Bixler, Edward O; Sun, Yuanfeng; Zhou, Junying; Ren, Rong; Li, Tao; Tang, Xiangdong

    2015-03-01

    Previous studies have suggested that insomnia with objective short sleep duration is associated with a higher risk of hypertension, and it has been speculated that the underlying mechanism is physiological hyperarousal. In this study, we tested whether insomnia with physiological hyperarousal measured by Multiple Sleep Latency Test (MSLT), a standard test of sleepiness/alertness, is associated with increased risk of hypertension. Two hundred nineteen chronic insomniacs and 96 normal sleepers were included in this study. Chronic insomnia was defined based on standard diagnostic criteria with symptoms lasting ≥6 months. All subjects underwent 1 night in laboratory polysomnography followed by a standard MSLT. We used the median mean MSLT value (ie, >14 minutes) and the 75th percentile of mean MSLT value (ie, >17 minutes) to define hyperarousal. Hypertension was defined based either on blood pressure measures or on diagnosis treatment by a physician. After controlling for age, sex, body mass index, apnea-hypopnea index, diabetes mellitus, smoking, alcohol, and caffeine use, insomnia combined with MSLT >14 minutes increased the odds of hypertension by 300% (odds ratio=3.27; 95% confidence interval=1.20-8.96), whereas insomnia combined with MSLT >17 minutes increased even further the odds of hypertension by 400% (odds ratio=4.33; 95% confidence interval=1.48-12.68) compared with normal sleepers with MSLT ≤14 minutes. Insomnia associated with physiological hyperarousal is associated with a significant risk of hypertension. Long MSLT values may be a reliable index of the physiological hyperarousal and biological severity of chronic insomnia. © 2015 American Heart Association, Inc.

  19. Electromagnetictherapy for Treatment of Insomnia: A clinical Trial Study

    Directory of Open Access Journals (Sweden)

    Fariba Sadeghi movahhed

    2012-04-01

    Full Text Available Background & Objectives: Insomnia is one of the most common sleep disorders in the world. It causes disruption in daily activities and increases the risk of major depression. Hence, clinically the appropriate and persistent treatment of insomnia is very important. Using of hypnotic drugs such as benzodiazepines is the common treatment for insomnia but they show several side effects and it seems that new medications should be used for treatment of sleep disorders. The aim of this study was comparison between the effects of electromagnetic therapy and conventional drug usage in the treatment of insomnia.   Methods: In a blind randomized clinical trial study, 60 people referred to the private office of the psychiatrist and experienced more than 3 months extended primary insomnia were selected. They were diagnosed by DSM-IV criteria and had no other underlying problems. The subjects were divided in two groups: 30 people in each and treated electromagnetically or with Alprazolam for 3 weeks. Before treatment, immediately and one month after treatment, quality of sleep and severity of the insomnia were evaluated by using the standard questionnaires and finally, the results were analyzed statistically.   Results : In this study, 60 individuals participated from whom 28 were male (46.7% and 32 patients were female (53.3%.The mean age was 37.3 years old in a range of 17- 65. The mean point of each questionnaire, before and immediately after treatment significantly didn't show any difference but one month after treatment, there was a significant difference in both groups.   Conclusion : To treat insomnia, electromagnetic therapy appears to be used as a replacement for sedative medicines. It also has more stability in comparison with other sedative medicines and no side effects have been reported yet.

  20. Insomnia as a predictor of high-lethality suicide attempts.

    Science.gov (United States)

    Pompili, M; Innamorati, M; Forte, A; Longo, L; Mazzetta, C; Erbuto, D; Ricci, F; Palermo, M; Stefani, H; Seretti, M E; Lamis, D A; Perna, G; Serafini, G; Amore, M; Girardi, P

    2013-12-01

    Research has demonstrated that patients with insomnia are at an increased risk of experiencing suicidal ideation and/or making a suicide attempt. To evaluate the relation between insomnia and suicidal behaviour. To examine factors associated with a diagnosis of insomnia in patients admitted to an Emergency Department (ED) and assessed by the psychiatrist in charge. Participants were 843 patients consecutively admitted to the ED of Sant'Andrea Hospital in Rome, between January 2010 and December 2011. All patients admitted were referred to a psychiatrist. A clinical interview based on the Mini International Neuropsychiatric Interview (MINI) and a semi-structured interview was conducted. Patients were asked about 'ongoing' suicidal ideation or plans for suicide. Forty-eight percent of patients received a diagnosis of bipolar disorder (BD), major depressive disorder (MDD) or an anxiety disorder; whereas, 17.1% were diagnosed with Schizophrenia or other non-affective psychosis. Patients with insomnia (compared to patients without insomnia) more frequently had a diagnosis of BD (23.9% vs. 12.4%) or MDD (13.3% vs. 9.5%; p suicide in the past 24 h (5.3% vs. 9.5%; p suicide more frequently used a violent method (64.3% vs. 23.6%; p suicide attempters. Our results do not support an association between insomnia and suicidal behaviour. However, suicide attempters with insomnia more frequently used violent methods, and this phenomenon should be taken into serious consideration by clinicians. © 2013 John Wiley & Sons Ltd.

  1. Behavioral treatment of insomnia: also effective for nocturia.

    Science.gov (United States)

    Tyagi, Shachi; Resnick, Neil M; Perera, Subashan; Monk, Timothy H; Hall, Martica H; Buysse, Daniel J

    2014-01-01

    To evaluate changes in self-reported nocturia in community-dwelling adults aged 60 and older who received behavioral treatment for chronic insomnia. Secondary analysis of a randomized controlled trial of a behavioral intervention for sleep. Academic medical center. Of the 79 enrollees, this analysis focused on 30 who, in addition to insomnia, also reported at least one nightly episode of waking up to void. The brief behavioral treatment of insomnia (BBTI) group (n = 14) received instructions on reducing time in bed and setting a regular sleep schedule. The information control (IC) group (n = 16) received printed materials. A nurse clinician delivered both interventions. Self-reported nocturnal awakenings to void assessed daily for 14 days at baseline and 4 weeks after the intervention. Participants who reported at least one episode of nocturia per night at baseline were included in this analysis. In individuals with nocturia at baseline, the total number of nocturnal voids over the 14-day assessment period decreased by 6.5 ± 4.8 in the BBTI group and increased by 1.3 ± 7.3 in the IC group (P = .04, effect size 0.82). After adjusting for baseline nocturia episodes, the difference remained significant (P = .05). In older adults with concurrent insomnia and nocturia, behavioral treatment directed solely at insomnia may also improve self-reported nocturia. Behavioral treatment of insomnia should be further investigated for its effect on nocturia in individuals with concurrent insomnia and nocturia. © 2013, Copyright the Authors Journal compilation © 2013, The American Geriatrics Society.

  2. BDNF in sleep, insomnia, and sleep deprivation.

    Science.gov (United States)

    Schmitt, Karen; Holsboer-Trachsler, Edith; Eckert, Anne

    2016-01-01

    The protein brain-derived neurotrophic factor (BDNF) is a member of the neurotrophin family of growth factors involved in plasticity of neurons in several brain regions. There are numerous evidence that BDNF expression is decreased by experiencing psychological stress and that, accordingly, a lack of neurotrophic support causes major depression. Furthermore, disruption in sleep homeostatic processes results in higher stress vulnerability and is often associated with stress-related mental disorders. Recently, we reported, for the first time, a relationship between BDNF and insomnia and sleep deprivation (SD). Using a biphasic stress model as explanation approach, we discuss here the hypothesis that chronic stress might induce a deregulation of the hypothalamic-pituitary-adrenal system. In the long-term it leads to sleep disturbance and depression as well as decreased BDNF levels, whereas acute stress like SD can be used as therapeutic intervention in some insomniac or depressed patients as compensatory process to normalize BDNF levels. Indeed, partial SD (PSD) induced a fast increase in BDNF serum levels within hours after PSD which is similar to effects seen after ketamine infusion, another fast-acting antidepressant intervention, while traditional antidepressants are characterized by a major delay until treatment response as well as delayed BDNF level increase. Key messages Brain-derived neurotrophic factor (BDNF) plays a key role in the pathophysiology of stress-related mood disorders. The interplay of stress and sleep impacts on BDNF level. Partial sleep deprivation (PSD) shows a fast action on BDNF level increase.

  3. Optimal implantation depth and adherence to guidelines on permanent pacing to improve the results of transcatheter aortic valve replacement with the medtronic corevalve system: The CoreValve prospective, international, post-market ADVANCE-II study

    NARCIS (Netherlands)

    A.S. Petronio (Anna); J.-M. Sinning (Jan-Malte); N.M. van Mieghem (Nicolas); G. Zucchelli (Giulio); G. Nickenig (Georg); R. Bekeredjian (Raffi); J. Bosmans (Johan); F. Bedogni (Francesco); M. Branny (Marian); K. Stangl (Karl); J. Kovac (Jan); M. Schiltgen (Molly); S. Kraus (Stacia); P.P.T. de Jaegere (Peter)

    2015-01-01

    textabstractObjectives The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis,

  4. Cognitive behavioral therapy for insomnia as a preparatory treatment for exposure therapy for posttraumatic stress disorder.

    Science.gov (United States)

    Baddeley, Jenna L; Gros, Daniel F

    2013-01-01

    Insomnia is present in a majority of individuals with posttraumatic stress disorder (PTSD). However, when both disorders are present, disagreements exist about whether to provide exposure therapy for PTSD before insomnia treatment, or vice versa. The current case study describes the psychological treatment of a psychotherapy-naive veteran with comorbid insomnia and PTSD. The patient initially refused exposure therapy for PTSD; thus, cognitive-behavioral therapy for insomnia (CBTi) was a first-step treatment. Cognitive Behavior Therapy for Insomnia provided insomnia symptom relief psychoeducation and self-monitoring of PTSD symptoms prepared the patient to enter exposure therapy. After six CBTi sessions, the patient completed seven sessions of trauma-specific exposure therapy. At the conclusion of treatment and at 90-day follow up, the patient demonstrated significant reductions in insomnia and PTSD symptoms. Findings support the safe and effective use of CBTi in patients with comorbid insomnia and PTSD to improve sleep and facilitate entry into exposure therapy for PTSD.

  5. Indicators of drug-seeking aberrant behaviours: the feasibility of use in observational post-marketing cohort studies for risk management.

    Science.gov (United States)

    Layton, Deborah; Osborne, Vicki; Al-Shukri, Mohammad; Shakir, Saad A W

    2014-08-01

    Problematic prescription drug use is reflected by or associated with drug-seeking aberrant behaviours. Research gaps include lack of post-marketing evidence and instruments. As part of the pharmacovigilance requirements, a risk management plan was developed for fentanyl buccal tablets (FEBT) by the manufacturer, with an additional pharmacovigilance activity requested by the regulatory authority, to investigate the risks of misuse, abuse, criminal use, off-label use and accidental exposure to FEBT after the product became commercially available. A Modified Prescription-Event Monitoring (M-PEM), observational, post-authorisation safety surveillance (PASS) study was conducted, with an overall aim to examine the use of FEBT in relation to their safety as prescribed in primary care in England. One of the exploratory objectives included estimating the prevalence of aberrant behaviours during FEBT treatment. To determine the feasibility of estimating the prevalence of risk factors associated with dependence on starting treatment and aberrant behaviours in patients during treatment with a prototypical abuse liable substance (fentanyl), as based on the application of an existing index (the Chabal criteria). Data were collected as part of the M-PEM PASS study; exposure and outcome data (including risk factors for dependence and aberrant behaviours based on behavioural not clinical manifestations) were derived from questionnaires sent to primary care physicians in England during April 2008 to June 2011. For the exploratory objective of interest, descriptive statistics and simple (non-weighted) risk scores were constructed on aggregate counts (score ≥3 considered 'high-risk'). Supplementary analyses explored the relationship between the two indices and the characteristics of patients with aberrant behaviours and those without (crude odds ratios plus 95% confidence interval (CI) were calculated). In a cohort of 551 patients, the prevalence of at least one pre-existing risk

  6. Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction

    Directory of Open Access Journals (Sweden)

    Nawroth F

    2015-04-01

    Full Text Available Frank Nawroth,1 Andreas Tandler-Schneider,2 Wilma Bilger3 1Centre for Reproductive and Prenatal Medicine, Endocrinology and Osteology, Hamburg, Germany; 2Center for Reproductive Medicine, Fertility Center Berlin, Berlin, Germany; 3Medical Affairs, Fertility, Endocrinology and General Medicine, Merck Serono GmbH, Darmstadt, Germany (an affiliate of Merck KGaA, Darmstadt, Germany Abstract: This prospective, noninterventional, post-marketing surveillance study evaluated doses of recombinant human follicle-stimulating hormone (r-hFSH using the redesigned follitropin alfa pen in women who were anovulatory or oligomenorrheic and undergoing ovulation induction (OI alone or OI with intrauterine insemination. The primary endpoint was the proportion of patients who achieved monofollicular or bifollicular development (defined as one or two follicles 15 mm. Secondary endpoints included characteristics of ovulation stimulation treatment, such as mean total and mean daily r-hFSH doses. Data were analyzed for 3,193 patients from 30 German fertility centers. The proportion of patients with monofollicular or bifollicular development was 71.1% (n=2,270 of a total of 3,193 patients; intent-to-treat population. The mean±standard deviation total and daily doses of r-hFSH were 696.9±542.5 IU and 61.7±29.4 IU, respectively. The three doses prescribed most frequently were: 37.5 IU (n=703 from N=3,189; 22.0%, 50.0 IU (n=1,056 from N=3,189; 33.1%, and 75.0 IU (n=738 from N=3,189; 23.1% on the first day of stimulation; and 37.5 IU (n=465 from N=3,189; 14.6%, 50.0 IU (n=922 from N=3,189; 28.9%, and 75.0 IU (n=895 from N=3,189; 28.1% on the last day of stimulation. This noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of patients studied and the small dose increment (12.5 IU of the redesigned follitropin alfa pen allowed individualized treatment of women undergoing OI. Keywords: ovulation

  7. Freeze-dried live attenuated smallpox vaccine prepared in cell culture "LC16-KAKETSUKEN": Post-marketing surveillance study on safety and efficacy compliant with Good Clinical Practice.

    Science.gov (United States)

    Nishiyama, Yasumasa; Fujii, Tatsuya; Kanatani, Yasuhiro; Shinmura, Yasuhiko; Yokote, Hiroyuki; Hashizume, So

    2015-11-09

    In Japan, production of smallpox vaccine LC16m8 (named LC16-KAKETSUKEN) was restarted and was determined to be maintained as a national stockpile in March 2002. To conduct a post-marketing surveillance study of the vaccination of freeze-dried live attenuated smallpox vaccine prepared in cell culture LC16-KAKETSUKEN using attenuated vaccinia strain LC16m8. The study complied with Good Clinical Practice, focusing on a comparison between primary vaccinees and re-vaccinees. 268 personnel (261 males and 7 females) of the Japan Ground Self-Defense Force were inoculated with LC16-KAKETSUKEN and thereafter adverse events and efficacy were evaluated. Among 268 vaccinee participants, the following vaccinees showed adverse events, none serious: 53 of 196 primary vaccinees (without previous smallpox vaccination), 4 of 71 re-vaccinees (with previous smallpox vaccination) and 1 vaccinee with unknown previous vaccination history. A breakdown of adverse events observed in this study (total 268 vaccinees) showed the following minor or mild adverse events: 52 (19.4%) swelling of axillary lymph node, 4 (1.5%) fever, 2 (0.7%) fatigue, 1 (0.4%) of rash, 14 (5.2%) erythema at the inoculation site, 1 (0.4%) swelling at the inoculation site and 1 (0.4%) autoinoculation. The incidence of adverse events for primary vaccinees (53/196; 27.0%) was significantly higher than for re-vaccinees (4/71; 5.6%). However, the proportion of vaccine take was significantly higher for primary vaccinees (185/196; 94.4%) than for re-vaccinees (58/71; 81.7%). Although the proportion of vaccine take of re-vaccinees was significantly lower than for primary vaccinees due to preexisting immunity by previous vaccination, no significant difference was found in neutralizing antibody titers between primary vaccinees and re-vaccinees at 1, 4 and 7 months after LC16-KAKETSUKEN vaccination. The present post-marketing surveillance study compliant with Good Clinical Practice demonstrated the efficacy and safety of the

  8. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    Science.gov (United States)

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  9. [Insomnia and habits to help to fall asleep among adults].

    Science.gov (United States)

    Fusz, Katalin; Faludi, Béla; Pusztai, Dorina; Sebők, Nóra; Oláh, András

    2016-12-01

    The quality of sleep can be influenced by several factors, insomnia in turn has an effect on the state of health. The aim of our survey is to measure the effects of insomnia, furthermore, the sleep affecting agents and habits to help to fall asleep among adults. We collected the online nationwide and the written datas from the South-Transdanubia region, 455 adults filled the questionnaire which contains the Athens Insomnia Scale. 13.4% of participants has insomnia, it is influenced by the quality of diet (psleep disorders are: work-related stress (35.6%), personal-life stress (35.4%) and pain (24.2%). In case of dormition problems most of the participants watch television (52.1%) and read (33%); 7.5% and 11.4% of the responders use sleeping pills and tisane. We attract attention to the prevalency and effects of insomnia, and the habits to help to fall asleep. Orv. Hetil., 2016, 157(49), 1955-1959.

  10. Quality Measures for the Care of Patients with Insomnia

    Science.gov (United States)

    Edinger, Jack D.; Buysse, Daniel J.; Deriy, Ludmila; Germain, Anne; Lewin, Daniel S.; Ong, Jason C.; Morgenthaler, Timothy I.

    2015-01-01

    The American Academy of Sleep Medicine (AASM) commissioned five Workgroups to develop quality measures to optimize management and care for patients with common sleep disorders including insomnia. Following the AASM process for quality measure development, this document describes measurement methods for two desirable outcomes of therapy, improving sleep quality or satisfaction, and improving daytime function, and for four processes important to achieving these goals. To achieve the outcome of improving sleep quality or satisfaction, pre- and post-treatment assessment of sleep quality or satisfaction and providing an evidence-based treatment are recommended. To realize the outcome of improving daytime functioning, pre- and post-treatment assessment of daytime functioning, provision of an evidence-based treatment, and assessment of treatment-related side effects are recommended. All insomnia measures described in this report were developed by the Insomnia Quality Measures Workgroup and approved by the AASM Quality Measures Task Force and the AASM Board of Directors. The AASM recommends the use of these measures as part of quality improvement programs that will enhance the ability to improve care for patients with insomnia. Citation: Edinger JD, Buysse DJ, Deriy L, Germain A, Lewin DS, Ong JC, Morgenthaler TI. Quality measures for the care of patients with insomnia. J Clin Sleep Med 2015;11(3):311–334. PMID:25700881

  11. [Present status and future of hypnotic drug treatment for insomnia].

    Science.gov (United States)

    Uchiyama, Makoto; Konno, Michiko

    2012-07-01

    Pharmacological treatments of insomnia have become safer since the first benzodiazepine receptor agonist (BzRA) hypnotic was introduced in the 1960's. Though BzRAs could hardly cause a fatal condition even in cases of overdosing, they had inherited the arguments on addiction and withdrawal from the prior studies of barbiturate hypnotics that indicated they are strongly addictive. In the 2000s, it was repeatedly demonstrated that insomnia as well as sleep deprivation underlie the development and deterioration of comorbid diseases such as hypertension, cardiovascular diseases, diabetes and depression, and that the proper use of hypnotic drugs is unlikely to cause tolerance, addiction nor rebound phenomena, but likely to be associated with improvement of QOL. Thus, the 2005's consensus report on chronic insomnia by NIH has recommended general physicians to facilitate insomnia treatment to prevent the development of physical and/or mental disorders. The author reviewed in this article the efficacy and side effects of BzRA hypnotics, a hypnotic drug therapy combined with cognitive and behavioral interventions, uses of melatonin receptor agonist in general and sleep medicine practices, and future utilization of newly-developed orexin antagonists for insomnia treatment.

  12. Sleep problems in bipolar disorders: more than just insomnia.

    Science.gov (United States)

    Steinan, M K; Scott, J; Lagerberg, T V; Melle, I; Andreassen, O A; Vaaler, A E; Morken, G

    2016-05-01

    Sleep problems in bipolar disorder (BD) are common, but reported rates vary from 10% to 80%, depending on definitions, methodologies and management of potential confounding factors. This multicenter study seeks to address these issues and also compares BD cases with Hypersomnia as well as the more commonly investigated Insomnia and No Sleep Problem groups. A cross-sectional comparison of sleep profiles in 563 BD I and II individuals who participated in a structured assessment of demographic, clinical, illness history and treatment variables. Over 40% cases met criteria for Insomnia and 29% for Hypersomnia. In univariate analysis, Insomnia was associated with BD II depression whilst Hypersomnia was associated with BD I depression or euthymia. After controlling for confounders and covariates, it was demonstrated that Hypersomnia cases were significantly more likely to be younger, have BD I and be prescribed antidepressants whilst Insomnia cases had longer illness durations and were more likely to be prescribed benzodiazepines and hypnotics. Whilst Insomnia symptoms are common in BD, Hypersomnia is a significant, frequently underexplored problem. Detailed analyses of large representative clinical samples are critical to extending our knowledge of differences between subgroups defined by sleep profile. © 2015 The Authors. Acta Psychiatrica Scandinavica Published by John Wiley & Sons Ltd.

  13. Evaluation of Insomnia Frequency, Beliefs and Attitudes Related Insomina in Primary Care

    OpenAIRE

    Zerrin Gamsýzkan; Selçuk Aslan

    2014-01-01

    OBJECTÝVE: Sleep disorders; are a health problem affecting the quality of life of individuals in society. We aimed to determine the prevalence of insomnia disorders, understand cognitive aprasials of pateints about their insomnia symptoms, and perpeutuating factors and coping mechanism to cope with insomnia problems. METHOD: In this study; patients with sleep problems were examined in a outpatient family medicine clinic in Ankara between 2009 and 2012. Insomnia Severity Index (ISI)...

  14. Yoga for the Treatment of Insomnia among Cancer Patients: Evidence, Mechanisms of Action, and Clinical Recommendations

    OpenAIRE

    Mustian, Karen M.; Janelsins, Michelle; Peppone, Luke J.; Kamen, Charles

    2014-01-01

    Up to 90% of cancer patients report symptoms of insomnia during and after treatment. Symptoms of insomnia include excessive daytime sleepiness, difficulty falling asleep, difficulty staying asleep, and waking up too early. Insomnia symptoms are among the most prevalent, distressing and persistent cancer- and cancer treatment-related toxicities reported by patients, and can be severe enough to increase cancer morbidity and mortality. Despite the ubiquity of insomnia symptoms, they are under-sc...

  15. Cognitive Behavioral Therapy for Insomnia in the Context of Cardiovascular Conditions

    OpenAIRE

    Conley, Samantha; Redeker, Nancy S.

    2015-01-01

    Cardiovascular disease (CVD) is the leading cause of death worldwide and is associated with high levels of morbidity, disability and poor quality of life. The prevalence of insomnia symptoms and diagnosis of insomnia are high among those with CVD. Although insomnia appears to be important to CVD, less is known about the effects of insomnia treatment on important biological, sleep, symptom, quality of life, functional and morbidity or mortality outcomes in people with or at-risk for CVD. The p...

  16. A Pilot Study of Cognitive-Behavioral Therapy of Insomnia in People with Mild Depression

    Science.gov (United States)

    Taylor, Daniel J.; Lichstein, Kenneth L.; Weinstock, Jeremiah; Sanford, Stacy; Temple, Jeff R.

    2007-01-01

    In some cases, insomnia and depression may have a reciprocal relationship, in which each aggravates and maintains the other. To test the hypothesis that reduction of insomnia would result in reduction of depression in patients (N=10) with both disorders, a repeated-measures design was used comparing depression and insomnia levels before and after…

  17. Neurobehavioral performance impairment in insomnia: relationships with self-reported sleep and daytime functioning.

    Science.gov (United States)

    Shekleton, Julia A; Flynn-Evans, Erin E; Miller, Belinda; Epstein, Lawrence J; Kirsch, Douglas; Brogna, Lauren A; Burke, Liza M; Bremer, Erin; Murray, Jade M; Gehrman, Philip; Lockley, Steven W; Rajaratnam, Shantha M W

    2014-01-01

    Despite the high prevalence of insomnia, daytime consequences of the disorder are poorly characterized. This study aimed to identify neurobehavioral impairments associated with insomnia, and to investigate relationships between these impairments and subjective ratings of sleep and daytime dysfunction. Cross-sectional, multicenter study. Three sleep laboratories in the USA and Australia. Seventy-six individuals who met the Research Diagnostic Criteria (RDC) for Primary Insomnia, Psychophysiological Insomnia, Paradoxical Insomnia, and/or Idiopathic Childhood Insomnia (44F, 35.8 ± 12.0 years [mean ± SD]) and 20 healthy controls (14F, 34.8 ± 12.1 years). N/A. Participants completed a 7-day sleep-wake diary, questionnaires assessing daytime dysfunction, and a neurobehavioral test battery every 60-180 minutes during an afternoon/evening sleep laboratory visit. Included were tasks assessing sustained and switching attention, working memory, subjective sleepiness, and effort. Switching attention and working memory were significantly worse in insomnia patients than controls, while no differences were found for simple or complex sustained attention tasks. Poorer sustained attention in the control, but not the insomnia group, was significantly associated with increased subjective sleepiness. In insomnia patients, poorer sustained attention performance was associated with reduced health-related quality of life and increased insomnia severity. We found that insomnia patients exhibit deficits in higher level neurobehavioral functioning, but not in basic attention. The findings indicate that neurobehavioral deficits in insomnia are due to neurobiological alterations, rather than sleepiness resulting from chronic sleep deficiency.

  18. Utilizing Cognitive-Behavioral Therapy for Insomnia to Facilitate Discontinuation of Sleep Medication in Chronic Insomnia Patients

    Directory of Open Access Journals (Sweden)

    Jason Ong

    2012-04-01

    Full Text Available Many chronic insomnia patients use sleep medication well beyond the recommended duration, and patients who are hypnotic-dependent encounter several challenges when attempting to discontinue. The current article presents these challenges and reviews studies that have added cognitive-behavioral therapy for insomnia (CBTI to a gradual tapering program to facilitate discontinuation of hypnotic medication in chronic insomnia patients. The current literature provides substantial support for using CBTI to facilitate discontinuation of hypnotic medication in chronic insomnia patients. Across several randomized clinical trials, the majority of the findings indicate that using CBTI, delivered by a therapist or self-help, along with a supervised or gradual tapering program is superior to tapering only or CBTI only in terms of medication discontinuation. Although these results are promising, it should be noted that the long-term evidence is more equivocal, as over 40% of patients relapse in the need for sleep medication within 2 years, which may highlight the importance of adding follow-up booster sessions in hypnotic-dependent insomniacs. These findings indicate that rather than choosing between CBT and hypnotic medication, clinicians might be better served using both treatment modalities to optimize the relative strengths of each treatment. Such an approach represents a more modern view of treating chronic insomnia patients by using both pharmacological and non-pharmacological tools.

  19. Psychometric properties of the Sleep Condition Indicator and Insomnia Severity Index in the evaluation of insomnia disorder.

    Science.gov (United States)

    Wong, Mark Lawrence; Lau, Kristy Nga Ting; Espie, Colin A; Luik, Annemarie I; Kyle, Simon D; Lau, Esther Yuet Ying

    2017-05-01

    The Sleep Condition Indicator (SCI) and Insomnia Severity Index (ISI) are commonly used instruments to assess insomnia. We evaluated their psychometric properties, particularly their discriminant validity against structured clinical interview (according to DSM-5 and ICSD-3), and their concurrent validity with measures of sleep and daytime functioning. A total of 158 young adults, 16% of whom were diagnosed with DSM-5 insomnia disorder and 13% with ICSD-3 Chronic Insomnia by structured interview, completed the ISI and SCI twice in 7-14 days, in addition to measures of sleep and daytime function. The Chinese version of the SCI was validated with good psychometric properties (ICC = 0.882). A cutoff of ≥8 on the ISI, ≤5 on the SCI short form, and ≤21 on the SCI achieved high discriminant validity (AUC > 0.85) in identifying individuals with insomnia based on both DSM-5 and ICSD-3 criteria. The SCI and ISI had comparable associations with subjective (0.18 sleep (0.31 disorder. Moreover, they showed good concordance with measures of daytime dysfunction, as well as subjective and objective sleep. The SCI and ISI are recommended for use in clinical and research settings. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Post-marketing safety evaluation of S-1 in patients with inoperable or recurrent breast cancer: especially in patients treated with S-1 + trastuzumab.

    Science.gov (United States)

    Saito, Yuki; Oshitanai, Risa; Terao, Mayako; Terada, Mizuho; Tsuda, Banri; Okamura, Takuho; Suzuki, Yasuhiro; Tokuda, Yutaka

    2011-09-01

    The purpose of this study was to assess the safety of S-1 in Japanese in inoperable or recurrent breast cancer patients. A prospective post-marketing surveillance was performed at 313 sites in Japan in patients with inoperable or recurrent breast cancer treated with S-1. We examined 1361 patients between January 2006 and December 2007 with regard to the incidence of adverse drug reactions graded by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. At least one adverse drug reaction was encountered by 858 patients, with an overall incidence of 63.0% (858/1361). The incidence of Grade 3 or higher adverse drug reactions in a descending order was 14.7% (200/1361). In this study, the most common combination drug was trastuzumab. The overall incidence of adverse drug reactions was 63.5% (431/679 patients) in patients treated with S-1 alone, and 55.9% (66/118 patients) in patients treated with S-1 + trastuzumab. Monotherapy with S-1 or combination therapy with S-1 + trastuzumab was well tolerated for inoperable or recurrent breast cancer patients.

  1. Non-invasive prenatal testing (NIPT): Europe's first multicenter post-market clinical follow-up study validating the quality in clinical routine.

    Science.gov (United States)

    Flöck, Anne; Tu, Ngoc-Chi; Rüland, Anna; Holzgreve, Wolfgang; Gembruch, Ulrich; Geipel, Annegret

    2017-11-01

    Non-invasive prenatal tests (NIPT) for the determination of fetal aneuploidies from maternal blood are firmly established in clinical routine. For the first time, the accuracy of an NIPT for the determination of trisomies 21, 18 and 13 in singleton pregnancies was assessed by means of a prospective German-wide multicenter post-market clinical follow-up study, to reliably evaluate the quality in clinical routine. The study covered the indications for testing, the test results, the rate of invasive diagnostics and the pregnancy outcome. 2232 cases were tested for trisomy 21. Of these, 1946 cases were additionally examined for trisomy 18 and 13. Sensitivity and specificity for trisomy 21 (43/43) and for trisomy 13 (2/2) were 100%, for trisomy 18 the sensitivity was 80% (4/5) with a specificity of 99.8%. Three false-positive results for trisomy 18 were observed (FPR 0.15%). The no-call rate was 0.5%. In this subgroup, 27.3% (3/11) aneuploidies were diagnosed. The rate of invasive procedures was 2.6%. NIPT provides a very high quality for the fetal trisomies 21, 13 and 18 in clinical routine. The results support the recommendation that NIPT should be offered after genetic counseling and only in conjunction with a qualified ultrasound examination.

  2. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up

    Directory of Open Access Journals (Sweden)

    Nobuyuki Yagi

    2014-05-01

    Full Text Available Objective: To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Methods: Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Results: Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7% of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%. No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. Conclusion: The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy.

  3. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective.

    Science.gov (United States)

    Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

    2017-06-01

    The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers.

  4. Evaluation of the Relative Abuse of an OROS® Extended-release Hydromorphone HCI Product: Results from three Post-market Surveillance Studies.

    Science.gov (United States)

    Butler, Stephen F; McNaughton, Emily C; Black, Ryan A; Cassidy, Theresa A

    2018-01-02

    Formulating prescription opioids to limit abuse remains a priority. OROS® extended-release (ER) hydromorphone HCl (EXALGO®) may have low abuse potential. Three post-marketing studies of the relative abuse liability of OROS hydromorphone ER were conducted. Estimates of abuse, unadjusted and adjusted for prescription volume, were generated for OROS hydromorphone ER and comparators from Q2 2010 through Q2 2014 for a high-risk, substance abuse treatment population and the general population using poison control center data. Comparators were selected for compound, market penetration, and route of administration (ROA) profile. ROA comparisons were made among the substance abuse treatment population. Internet discussion was examined to determine abusers' interest in and desire for the OROS formulation. Examination of abuse prevalence among adults within substance abuse treatment, intentional poison exposures and Internet discussion levels generally support the hypothesis that OROS hydromorphone ER may have lower abuse potential than many other opioid products. OROS hydromorphone ER also appears to be abused less often by alternate ROAs (e.g., snorting and injection). Lower levels of online discussion were observed along with relatively low endorsement for abuse. Abuse of OROS hydromorphone ER was observed in high-risk substance abuse and general population samples but at a very low relative prevalence. Evidence suggests it may be less often abused by alternate ROAs than some comparators. Online data did not find evidence of high levels of desire for OROS hydromorphone ER by recreational abusers. Continued monitoring of this product's abuse liability is warranted.

  5. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    Science.gov (United States)

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

  6. Safety and Effectiveness of Mirabegron in Patients with Overactive Bladder Aged ≥75 Years: Analysis of a Japanese Post-Marketing Study.

    Science.gov (United States)

    Yoshida, Masaki; Nozawa, Yumiko; Kato, Daisuke; Tabuchi, Hiromi; Kuroishi, Kentarou

    2017-09-12

    A 12-week post-marketing study was conducted to provide real-world data on Japanese patients with overactive bladder (OAB) initiating treatment with mirabegron. This post-hoc analysis focused on safety and effectiveness of mirabegron in patients aged ≥75 versus mass index (BMI; BMI < 18.5: 4.2% vs 3.2%), longer OAB duration (≥3 years: 24.6% vs 20.3%) and more severe OAB symptoms (severe: 17.0% vs 11.2%). A significantly greater percentage of patients aged ≥75 versus <75 years had comorbidities (77.8% vs 66.0%) and used concomitant drugs (58.3% vs 48.7%; P < 0.001). Incidence of ADR was observed in 7.00% and 5.19% of patients aged ≥75 versus <75 years, respectively. At EoT, mirabegron treatment was reported 'effective' in 79.3% versus 82.1% of patients aged ≥75 versus <75 years, respectively. Mean total OABSS decreased significantly from baseline, and exceeded the MCIC in 61.0% and 65.9% of patients aged ≥75 and <75 years, respectively. Similar changes were observed for I-PSS QoL in both groups. In a real-world clinical setting, mirabegron was well-tolerated and effective in patients aged ≥75 and <75 years. © 2017 John Wiley & Sons Australia, Ltd.

  7. The real-life safety and efficacy of vardenafil: an international post-marketing surveillance study--results from 29 358 German patients.

    Science.gov (United States)

    van Ahlen, H; Zumbé, J; Stauch, K; Landen, H

    2005-01-01

    We assessed the safety, efficacy and patient acceptability of vardenafil (Levitra, Bayer HealthCare, Leverkusen, Germany) under real-life conditions in patients with erectile dysfunction (ED) in a multinational post-marketing surveillance study. An initial and up to two follow-up visits were documented for 29 358 German ED patients receiving vardenafil. Patients were interviewed about overall treatment success, and individual sexual attempts were evaluated in a patient questionnaire. Overall erectile improvement was reported by 93.9% of physicians, and similar improvement rates were reported for both 10 mg and 20 mg vardenafil dosages. Most patients experienced improved erections after the first (73.6%) or second (88.5%) tablet. Sexual attempts were successful with respect to partner penetration in 94.9% of patients and with respect to maintenance of erection during intercourse in 87.7% of patients. Adverse drug reactions were very rare (1.3% of patients). Vardenafil was highly effective, reliable and well tolerated in ED patients treated under real-life conditions.

  8. Epidemiologia da insônia Epidemiology of the insomnia

    Directory of Open Access Journals (Sweden)

    José Carlos Souza

    2004-04-01

    Full Text Available Os autores fizeram uma ampla revisão da literatura científica mundial sobre a epidemiologia da insônia, o mais prevalente dos distúrbios do sono. Foi feito um levantamento bibliográfico, no período de janeiro de 2002 a novembro de 2003, das publicações dos últimos 30 anos, nos bancos de dados MEDLINE e LILACS, sobre a definição e prevalência da insônia, além de suas conseqüências socioeconômicas. As palavras-chaves pesquisadas foram: distúrbio de iniciar o sono, distúrbio de manutenção do sono, distúrbio do despertar precoce, insônia, distúrbios do sono, prevalência da insônia, conseqüências da insônia. Observou-se uma grande variação dos critérios de definição da insônia, dos desenhos metodológicos e dos resultados dos estudos epidemiológicos, o que prejudicou as comparações dos dados das várias pesquisas. As futuras linhas de pesquisa sobre a epidemiologia da insônia devem se embasar em um consenso sobre sua definição e critérios metodológicos mais bem-definidos.A vast literature review on the insomnia epidemiology, the most common sleep disorder, using MEDLINE and LILACS last 30 years of data, was performed from January 2002 to November 2003. The key-words were: sleep initiation disorders, sleep maintenance disorders, early awakening disorder, insomnia, sleep disorders, insomnia prevalence, insomnia consequences. Several insomnia definition criteria and epidemiology researches methods, with data comparison difficulties, were noticed. In the future it will be necessary similar insomnia definition and epidemiology studies criteria.

  9. Patient Preferences for Managing Insomnia: A Discrete Choice Experiment.

    Science.gov (United States)

    Cheung, Janet M Y; Bartlett, Delwyn J; Armour, Carol L; Saini, Bandana; Laba, Tracey-Lea

    2018-03-03

    Despite the rapid development of effective treatments, both pharmacological and non-pharmacological, insomnia management remains suboptimal at the practice interface. Patient preferences play a critical role in influencing treatment outcomes. However, there is currently a mismatch between patient preferences and clinician recommendations, partly perpetuated by a limited understanding of the patients' decision-making process. The aim of our study was to empirically quantify patient preferences for treatment attributes common to both pharmacological and non-pharmacological insomnia treatments. An efficient dual-response discrete choice experiment was conducted to evaluate patient treatment preferences for managing insomnia. The sample included 205 patients with self-reported insomnia and an Insomnia Severity Index ≥ 14. Participants were presented with two unlabelled hypothetical scenarios with an opt-out option across 12 choice sets. Data were analyzed using a mixed multinomial logit model to investigate the influence of five attributes (i.e. time, onset of action, maintainability of improved sleep, length of treatment, and monthly cost) on treatment preferences. Treatments were preferentially viewed if they conferred long-term sleep benefits (p < 0.05); had an ongoing, as opposed to a predefined, duration of treatment course (p < 0.05); required some, as opposed to no, additional time commitment (p < 0.05); and had lower monthly out-of-pocket treatment costs (p < 0.001). However, treatment onset of action had no influence on preference. Age, help-seeking status, concession card status and fatigue severity significantly influenced treatment preference. Participants' prioritization of investing time in treatment and valuing the maintainability of therapeutic gains suggests a stronger inclination towards non-pharmacological treatment, defying current assumptions that patients prefer 'quick-fixes' for managing insomnia.

  10. Preferences for different insomnia treatment options in people with schizophrenia and related psychoses: A qualitative study

    Directory of Open Access Journals (Sweden)

    Flavie eWaters

    2015-07-01

    Full Text Available Symptoms of psychosis such as hallucinations and delusions can be intrusive and unwanted and often remain treatment-resistant. Due to recent progress in basic and clinical sciences, novel approaches such as sleep-based interventions are increasingly becoming offered to address the physical and mental health issues of people with severe mental illness. While the primary outcome is to improve sleep, studies have demonstrated that interventions that target symptoms of insomnia can also produce improvements in the severity of psychotic symptoms, quality of life and functional outcomes. This study presents qualitative data on the attitudes and preferences of people with schizophrenia and schizo-affective disorders to three different types of therapies for insomnia (standard pharmacological, melatonin-based, and cognitive and/or behaviour therapy. Interviews included discussions regarding the perceived advantages and limitations of different therapies, enablers to taking up the preferred option, as well as personal strategies that have helped respondents with sleep problems in the past. Results showed that, when given the choice, these individuals prefer psychological and behavioural-type therapy to other sleep interventions because of its potential to support and empower them in taking responsibility for their own recovery. Pharmacological therapies, by contrast, are viewed as useful in managing acute sleep problems, but only as a short-term solution. Overall, the findings underscore the need for patients’ active engagement when making decisions about treatment options.

  11. Listening to music for improving sleep in adults with insomnia

    DEFF Research Database (Denmark)

    Jespersen, Kira Vibe; Koenig, Julian; Jennum, Poul

    2013-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows:To assess the effects of music listening on sleep quality in adults with insomnia and to assess the influence of specific variables that may moderate the effect.......This is the protocol for a review and there is no abstract. The objectives are as follows:To assess the effects of music listening on sleep quality in adults with insomnia and to assess the influence of specific variables that may moderate the effect....

  12. Midlife insomnia and subsequent mortality: the Hordaland health study.

    Science.gov (United States)

    Sivertsen, Børge; Pallesen, Ståle; Glozier, Nick; Bjorvatn, Bjørn; Salo, Paula; Tell, Grethe S; Ursin, Reidun; Øverland, Simon

    2014-07-15

    Previous research suggests a possible link between insomnia and mortality, but findings are mixed and well-controlled studies are lacking. The aim of the current study was to examine the effect of insomnia in middle age on all-cause mortality. Using a cohort design with 13-15 years follow-up, mortality registry data were linked to health information obtained during 1997-99, as part of the community-based Hordaland Health Study (HUSK), in Western Norway. 6,236 participants aged 40-45 provided baseline information on self- reported insomnia using the Karolinska Sleep Questionnaire Scale (defined according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), sociodemographic factors, health behaviors, shift/night-work, obstructive sleep apnea symptoms, sleep duration, sleep medication use, anxiety, depression, as well as a range of somatic diagnoses and symptoms. Height, weight and blood pressure were measured. Information on mortality was obtained from the Norwegian Cause of Death Registry. Insomnia was reported by 5.6% (349/6236) at baseline and a significant predictor of all-cause-mortality (hazard ratio [HR] = 2.74 [95% CI:1.75-4.30]). Adjusting for all confounders did not attenuate the effect (HR = 3.34 [95% CI:1.67-6.69]). Stratifying by gender, the effect was especially strong in men (HR = 4.72 [95% CI:2.48-9.03]); but also significant in women (adjusted HR = 1.96 [95% CI:1.04-3.67]). The mortality risk among participants with both insomnia and short sleep duration (insomnia in combination with normal/greater sleep duration was not associated with mortality. Insomnia was associated with a three-fold risk of mortality over 13-15 years follow-up. The risk appeared even higher in males or when insomnia was combined with short sleep duration, although such unadjusted subgroup analyses should be interpreted with caution. Establishing prevention strategies and low-threshold interventions should consequently be a prioritized task

  13. Midlife insomnia and subsequent mortality: the Hordaland health study

    Science.gov (United States)

    2014-01-01

    Background Previous research suggests a possible link between insomnia and mortality, but findings are mixed and well-controlled studies are lacking. The aim of the current study was to examine the effect of insomnia in middle age on all-cause mortality. Methods Using a cohort design with 13-15 years follow-up, mortality registry data were linked to health information obtained during 1997-99, as part of the community-based Hordaland Health Study (HUSK), in Western Norway. 6,236 participants aged 40–45 provided baseline information on self- reported insomnia using the Karolinska Sleep Questionnaire Scale (defined according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), sociodemographic factors, health behaviors, shift/night-work, obstructive sleep apnea symptoms, sleep duration, sleep medication use, anxiety, depression, as well as a range of somatic diagnoses and symptoms. Height, weight and blood pressure were measured. Information on mortality was obtained from the Norwegian Cause of Death Registry. Results Insomnia was reported by 5.6% (349/6236) at baseline and a significant predictor of all-cause-mortality (hazard ratio [HR] = 2.74 [95% CI:1.75-4.30]). Adjusting for all confounders did not attenuate the effect (HR = 3.34 [95% CI:1.67-6.69]). Stratifying by gender, the effect was especially strong in men (HR = 4.72 [95% CI:2.48-9.03]); but also significant in women (adjusted HR = 1.96 [95% CI:1.04-3.67]). The mortality risk among participants with both insomnia and short sleep duration (insomnia in combination with normal/greater sleep duration was not associated with mortality. Conclusions Insomnia was associated with a three-fold risk of mortality over 13-15 years follow-up. The risk appeared even higher in males or when insomnia was combined with short sleep duration, although such unadjusted subgroup analyses should be interpreted with caution. Establishing prevention strategies and low

  14. Nocturia, Insomnia Symptoms and Mortality among Older Men

    DEFF Research Database (Denmark)

    Endeshaw, Y. W.; Schwartz, A. V.; Stone, K. A.

    2016-01-01

    episodes per night, in comparison to those with 0-1 episodes (HR [CI] : 1.21 [1.00-1.47], p = 0.055), even after controlling for baseline characteristics which included demographic variables, body mass index, lower urinary tract symptoms, use of loop diuretics, insomnia symptoms, feeling excessively sleepy.......97-1.44], p = 0.100). Conclusions: Nocturia is associated with mortality independent of insomnia symptoms and sleep duration. The relationship is explained in part by prevalent cardiovascular disease and diabetes mellitus. The results underscore the impact of these medical conditions on the association...

  15. The Pediatric Sleep Clinical Global Impressions Scale-A New Tool to Measure Pediatric Insomnia in Autism Spectrum Disorders.

    Science.gov (United States)

    Malow, Beth A; Connolly, Heidi V; Weiss, Shelly K; Halbower, Ann; Goldman, Suzanne; Hyman, Susan L; Katz, Terry; Madduri, Niru; Shui, Amy; Macklin, Eric; Reynolds, Ann M

    2016-06-01

    To pilot a clinician-based outcome measure that provides complementary information to objective measures and parent-based questionnaires for insomnia in children with autism spectrum disorders (ASD). The authors developed a Pediatric Sleep Clinical Global Impressions Scale (CGI). Questions included (1) the child's ability to fall asleep and remain sleeping independently (i.e., apart from parents); (2) bedtime resistance; (3) sleep onset delay; (4) night awakening; (5) parental satisfaction with their child's current sleep patterns; (6) family functioning as affected by their child's current sleep patterns; and (7) clinician's overall concern with the child's sleep. After refining the instrument through the evaluation of vignettes by ASD and sleep experts, the authors piloted the Pediatric Sleep CGI in a 12-week randomized trial of iron supplementation in children with ASD. Clinicians completed Pediatric Sleep CGIs and structured sleep histories, parents completed the Children's Sleep Habits Questionnaire (CSHQ), and children wore actigraphy watches. In repeated measures models, the Pediatric Sleep CGI and CSHQ were correlated for sleep onset delay (r = .66, p sleep onset delay and actigraphy sleep onset delay scores (r = .75, p = .0095) were also correlated. The overall CGI-S showed improvement with therapy (p = .047). The Pediatric Sleep CGI shows promise in measuring clinician-rated outcomes in pediatric insomnia in children with ASD. Larger samples will be necessary to examine reliability, validity, and measure to change, as well as applicability to other populations with pediatric insomnia.

  16. Is insomnia a perpetuating factor for late-life depression in the IMPACT cohort?

    Science.gov (United States)

    Pigeon, Wilfred R; Hegel, Mark; Unützer, Jürgen; Fan, Ming-Yu; Sateia, Michael J; Lyness, Jeffrey M; Phillips, Cindy; Perlis, Michael L

    2008-04-01

    Insomnia and depressive disorders are significant health problems in the elderly. Persistent insomnia is a risk factor for the development of new-onset and recurrent major depressive disorder (MDD). Less clear is whether persistent insomnia may perpetuate MDD andlor dysthymia. The present longitudinal study examines the relationship of insomnia to the continuation of depression in the context of an intervention study in elderly subjects. Data were drawn from Project IMPACT, a multisite intervention study, which enrolled 1801 elderly patients with MDD and/or dysthymia. In the current study, subjects were assigned to an insomnia-status group (Persistent, Intermediate, and No Insomnia) based on insomnia scores at both baseline and 3-month time points. Logistic regressions were conducted to determine whether Persistent Insomnia was prospectively associated with increased risk of remaining depressed and/or achieving a less than 50% clinical improvement at 6 and at 12 months compared with the No Insomnia reference group. The Intermediate Insomnia group was compared with the other 2 groups to determine whether a dose-response relationship existed between insomnia type and subsequent depression. Eighteen primary clinics in 5 states. Older adults (60+) with depression. Overall, patients with persistent insomnia were 1.8 to 3.5 times more likely to remain depressed, compared with patients with no insomnia. The findings were more robust in patients receiving usual care for depression than in patients receiving enhanced care. Findings were also more robust in subjects who had MDD as opposed to those with dysthymia alone. These findings suggest that, in addition to being a risk factor for a depressive episode, persistent insomnia may serve to perpetuate the illness in some elderly patients and especially in those receiving standard care for depression in primary care settings. Enhanced depression care may partially mitigate the perpetuating effects of insomnia on depression.

  17. Detecting insomnia in patients with low back pain: accuracy of four self-report sleep measures

    Science.gov (United States)

    2013-01-01

    Background Although insomnia is common in patients with low back pain (LBP), it is unknown whether commonly used self-report sleep measures are sufficiently accurate to screen for insomnia in the LBP population. This study investigated the discriminatory properties of the Pittsburgh Sleep Quality Index (Pittsburgh questionnaire), Insomnia Severity Index (Insomnia index), Epworth Sleepiness Scale (Epworth scale) and the sleep item of the Roland and Morris Disability Questionnaire (Roland item) to detect insomnia in patients with LBP by comparing their accuracy to detect insomnia to a sleep diary. The study also aimed to determine the clinical optimal cut-off scores of the questionnaires to detect insomnia in the LBP population. Methods Seventy nine patients with LBP completed the four self-reported questionnaires and a sleep diary for 7 consecutive nights. The accuracy of the questionnaires was evaluated using Receiver Operator Characteristic (ROC) curves with the Area Under the Curve (AUC) used to examine each test’s accuracy to discriminate participants with insomnia from those without insomnia. Results The Pittsburgh questionnaire and Insomnia index had moderate accuracy to detect insomnia (AUC = 0.79, 95% CI = 0.68 to 0.87 and AUC = 0.78, 95% CI = 0.67 to 0.86 respectively), whereas the Epworth scale and the Roland item were not found to be accurate discriminators (AUC = 0.53, 95% CI = 0. 41 to 0.64 and AUC = 0.64, 95% CI = 0.53 to 0.75 respectively). The cut-off score of > 6 for the Pittsburgh questionnaire and the cut-off point of > 14 for the Insomnia index provided optimal sensitivity and specificity for the detection of insomnia. Conclusions The Pittsburgh questionnaire and Insomnia index had similar ability to screen for insomnia in patients with low back pain. PMID:23805978

  18. Retrospective, nonrandomized controlled study on autoadjusting, dual-pressure positive airway pressure therapy for a consecutive series of complex insomnia disorder patients

    Directory of Open Access Journals (Sweden)

    Krakow B

    2017-03-01

    Full Text Available Barry Krakow,1–3 Natalia D McIver,1,2 Victor A Ulibarri,1,2 Michael R Nadorff4,5 1Sleep & Human Health Institute, 2Maimonides Sleep Arts & Sciences, Ltd, Albuquerque, 3Los Alamos Medical Center, Los Alamos, NM, 4Department of Psychology, Mississippi State University, Mississippi, MS, 5Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA Purpose: Emerging evidence shows that positive airway pressure (PAP treatment of obstructive sleep apnea (OSA and upper airway resistance syndrome (UARS in chronic insomnia patients (proposed “complex insomnia” disorder leads to substantial decreases in insomnia severity. Although continuous PAP (CPAP is the pressure mode most widely researched, intolerance to fixed pressurized air is rarely investigated or described in comorbidity patients. This retrospective study examined dual pressure, autoadjusting PAP modes in chronic, complex insomnia disorder patients.Patients and methods: Chronic insomnia disorder patients (mean [SD] insomnia severity index [ISI] =19.11 [3.34] objectively diagnosed with OSA or UARS and using either autobilevel PAP device or adaptive servoventilation (ASV device after failing CPAP therapy (frequently due to intolerance to pressurized air, poor outcomes, or emergence of CSA were divided into PAP users (≥20 h/wk and partial users (<20 h/wk for comparison. Subjective and objective baseline and follow-up measures were analyzed.Results: Of the 302 complex insomnia patients, PAP users (n=246 averaged 6.10 (1.78 nightly hours and 42.71 (12.48 weekly hours and partial users (n=56 averaged 1.67 (0.76 nightly hours and 11.70 (5.31 weekly hours. For mean (SD decreases in total ISI scores, a significant (group × time interaction was observed (F[1,300]=13.566; P<0.0001 with PAP users (–7.59 [5.92]; d=1.63 showing superior results to partial users (-4.34 [6.13]; d=0.81. Anecdotally, patients reported better tolerability with advanced PAP

  19. Insomnia in a chronic musculoskeletal pain with disability population is independent of pain and depression.

    Science.gov (United States)

    Asih, Sali; Neblett, Randy; Mayer, Tom G; Brede, Emily; Gatchel, Robert J

    2014-09-01

    Insomnia is frequently experienced by patients suffering from chronic musculoskeletal disorders but is often seen as simply a symptom of pain or depression and not as an independent disorder. Compared with those who experience only chronic pain, patients with both chronic pain and insomnia report higher pain intensity, more depressive symptoms, and greater distress. However, insomnia has not yet been systematically studied in a chronic musculoskeletal pain with disability population. This study assessed the prevalence and severity of patient-reported insomnia, as well as the relationship among insomnia, pain intensity, and depressive symptoms, in a chronic musculoskeletal pain with disability population. This was a retrospective study of prospectively captured data. A consecutive cohort of 326 chronic musculoskeletal pain with disability patients (85% with spinal injuries) entered a functional restoration treatment program. All patients signed a consent form to participate in this protocol. Insomnia was assessed with the Insomnia Severity Index, a validated patient-report measure of insomnia symptoms. Four patient groups were formed: no clinically significant insomnia (score, 0-7); subthreshold insomnia (score, 8-14); moderate clinical insomnia (score, 15-21); and severe clinical insomnia (score, 22-28). Three patterns of sleep disturbance were also evaluated: early, middle, and late insomnia. Additional validated psychosocial patient-reported data were collected, including the Pain Visual Analog Scale, the Beck Depression Inventory, the Oswestry Disability Index, and the Pain Disability Questionnaire. Patients completed a standard psychosocial assessment battery on admission to the functional restoration program. The program included a quantitatively directed exercise process in conjunction with a multimodal disability management approach. The four insomnia groups were compared on demographic and psychosocial variables. The shared variances among insomnia

  20. The socio-economics of insomnia: the materials and the methods.

    Science.gov (United States)

    Stoller, M

    1997-01-01

    Insomnia affects about one-third of the population, and is associated with increased morbidity and mortality, reduced production and higher rates of accidents. This suggests that insomnia may burden society with significant cost. However, a precise economic analysis of insomnia is a challenge. Insomnia is part of a very complex interplay of physical and psychological illness, functioning both as a cause and as a consequence. In this paper, some of the methodological issues related to an economic analysis of insomnia are discussed. Data is presented using an economic analysis as an organizer, thus illustrating what conclusions can be drawn, and where further research is needed.

  1. Anxiety Mediates the Relationship between Perfectionism and Insomnia Symptoms: A Longitudinal Study.

    Science.gov (United States)

    Akram, Umair; Ellis, Jason G; Barclay, Nicola L

    2015-01-01

    Individuals with insomnia often report aspects of perfectionism and symptoms of anxiety and depression. Investigation of these factors together has been limited. As such, the aim of the present study was to examine the extent to which the association between perfectionism and insomnia symptoms was mediated by anxiety and depression, concurrently and longitudinally. Seventy-six members from the general-population participated at baseline. Data from 57 participants were subsequently analysed at twelve-month follow-up. Insomnia symptoms were assessed using The Insomnia Severity Index (ISI). Perfectionism was assessed using two Multidimensional Perfectionism Scales (F-MPS; HF-MPS). Symptoms of anxiety and depression were assessed using The Hospital Anxiety and Depression Scale (HADS). Correlational analysis examined longitudinal associations between perfectionism and insomnia symptoms. Hierarchical regression analysis examined whether significant associations remained after controlling for anxiety and depression. Baseline insomnia symptoms were associated with future doubts about action. Further, this relationship was mediated by preceding symptoms of anxiety and concurrent symptoms of insomnia. Similarly, baseline insomnia symptoms were also associated with future parental criticism. However this relationship was partially mediated by preceding symptoms of anxiety, and was not mediated by concurrent insomnia symptoms. Symptoms of insomnia appear to be related to an increase in negative perfectionistic thinking in the form of doubts about action and parental criticism, however these relationships appear to be mediated by symptoms of anxiety. Therefore, treatments for insomnia should address anxiety symptoms with the prospect of preventing the accentuation of aspects of perfectionism due to poor sleep.

  2. The independent relationships between insomnia, depression, subtypes of anxiety, and chronotype during adolescence.

    Science.gov (United States)

    Alvaro, Pasquale K; Roberts, Rachel M; Harris, Jodie K

    2014-08-01

    To investigate the independent effects of depression and subtypes of anxiety on insomnia, and vice versa, and the independent effect of chronotype on insomnia, depression, and subtypes of anxiety. In all, 318 South Australian high school students from grades 7-11 (age range, 12-18years; mean, 14.97±1.34) participated in this cross-sectional study. Validated self-report questionnaires were used to assess insomnia, depression, subtypes of anxiety, and chronotype. After confounder variables were controlled, insomnia predicted depression and panic disorder (PD), whereas insomnia was predicted by depression and generalized anxiety disorder (GAD). Obsessive-compulsive disorder (OCD), separation anxiety (SAD), and social phobia (SP) were not significantly related to insomnia. Eveningness predicted the models in which depression and PD predicted insomnia and vice versa. Eveningness also predicted the models in which insomnia was predicted by OCD, SAD, and SP. Insomnia independently predicts depression and is predicted by depression and GAD, but not by other forms of anxiety. The independent prediction of insomnia on PD is unlikely to be clinically significant. Chronotype independently predicts and hence is a risk factor for insomnia and depression, but not subtypes of anxiety. Theoretical and clinical implications are discussed. Crown Copyright © 2014. Published by Elsevier B.V. All rights reserved.

  3. Patients' and clinicians' experiences and perceptions of the primary care management of insomnia: qualitative study.

    Science.gov (United States)

    Davy, Zowie; Middlemass, Jo; Siriwardena, Aloysius N

    2015-10-01

    Insomnia is common leading to patients with sleep problems often presenting to primary care services including general practice, community pharmacies and community mental health teams. Little is known about how health professionals in primary care respond to patients with insomnia. We aimed to explore health professionals' and patients' experiences and perceptions of the management of insomnia in primary care. We used a qualitative design and thematic approach. Primary care in Nottinghamshire and Lincolnshire. We undertook focus groups and one-to-one interviews with a purposive sample of health professionals and adults with insomnia. We interviewed 28 patients and 23 health professionals. Practitioners focused on treating the cause of insomnia rather than the insomnia itself. They described providing stepped care for insomnia, but this focused on sleep hygiene which patients often disregarded, rather than cognitive behavioural therapy for insomnia (CBT-I). Practitioners were ambivalent towards hypnotic drugs but often colluded with patients to prescribe to avoid confrontation or express empathy. Patients sometimes took hypnotics in ways that were not intended, for example together with over-the-counter medication. Practitioners and patients were sometimes but not always concerned about addiction. Practitioners sometimes prescribed despite these concerns but at other times withdrew hypnotics abruptly without treating insomnia. Both patients and practitioners wanted more options and better training for the management of insomnia in primary care. A better understanding of the current approaches and difficulties in the management of insomnia will help to inform more therapeutic options and health professional training. © 2013 John Wiley & Sons Ltd.

  4. Sleep system sensitization: evidence for changing roles of etiological factors in insomnia.

    Science.gov (United States)

    Kalmbach, David A; Pillai, Vivek; Arnedt, J Todd; Anderson, Jason R; Drake, Christopher L

    2016-05-01

    To test for sensitization of the sleep system in response to insomnia development and major life stress. In addition, to evaluate the impact on depression and anxiety associated with sleep system sensitization. A longitudinal study with three annual assessments. The community-based sample included 262 adults with no history of insomnia or depression who developed insomnia one year after baseline (67.6% female; 44.0 ± 13.4 yr). Measures included the Ford Insomnia Response to Stress Test to assess sleep reactivity, Quick Inventory of Depressive Symptomatology, and Beck Anxiety Inventory. Insomnia classification was based on DSM-IV criteria. Sleep system sensitization was operationally defined as significant increases in sleep reactivity. Sensitization of the sleep system was observed from baseline to insomnia onset at 1-yr follow-up among insomniacs with low premorbid vulnerability (p insomnia remission (p insomnia onset. The impact of sensitization on depression was stable at 2-yr follow-up (p = 0.01). Evidence supports sensitization of the sleep system as a consequence of insomnia development and major life stress among individuals with low premorbid sleep reactivity. Sleep system sensitization may serve as a mechanism by which insomnia is perpetuated. Harmful effects of the sensitization process may increase risk for insomnia-related depression and anxiety. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. GOAL: multicenter, open-label, post-marketing study of flavocoxid, a novel dual pathway inhibitor anti-inflammatory agent of botanical origin.

    Science.gov (United States)

    Pillai, Lakshmi; Burnett, Bruce P; Levy, Robert M

    2010-05-01

    GOAL (Gauging Osteoarthritis [OA] with Limbrel*), an open-label, post-marketing study was performed to determine the overall efficacy and gastrointestinal (GI) tolerability of flavocoxid, a novel, plant-based, anti-inflammatory medication, in a 'real world' clinical practice setting. To this end, the study enrolled several unique patient types including nonsteroidal anti-inflammatory drug (NSAID) naïve patients, those who had used NSAIDs in the past, regardless of outcome (positive or negative), and those who had previously taken a gastroprotective medication to improve GI tolerability or continued to take it as a precautionary measure to prevent NSAID-associated GI damage. A total of 1067 individuals at 41 rheumatology practices were enrolled and prescribed flavocoxid, 500 mg b.i.d., for 60 days. The Physician Global Assessment of Disease (PGAD) visual analog scale (VAS) was used as a global measure to assess the signs and symptoms of OA, including joint discomfort, functional stiffness, functional mobility and quality of life. In addition, overall tolerability and upper GI tolerability were assessed by individual questions scored on a 5-part Likert scale. The physicians also monitored any interruption in, or cessation of use of flavocoxid due to a GI issue as well as changes in the use of gastroprotective medications. Adverse event (AE) monitoring was also conducted. Of the 1005 patients who completed all follow-up visits, physicians recorded an average improvement in VAS scores from 60.1 +/- 18.8 at baseline to 42.5 +/- 21.9 at 8 weeks (p 30% reduction in or cessation of the use of gastroprotective medications such as proton pump inhibitors (PPI) or histamine-2 receptor antagonists (H2s) in subjects (p lack of control.

  6. Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

    Science.gov (United States)

    Reichmann, H; Jost, W H

    2010-09-01

    The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

  7. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study.

    Science.gov (United States)

    Bravo, Lulu; Chitraka, Amarjeet; Liu, Aixue; Choudhury, Jaydeep; Kumar, Kishore; Berezo, Lennie; Cimafranca, Leonard; Chatterjee, Pallab; Garg, Pankaj; Siriwardene, Prasanna; Bernardo, Rommel; Mehta, Shailesh; Balasubramanian, Sundaram; Karkada, Naveen; Htay Han, Htay

    2014-01-01

    Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.

  8. Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report

    Science.gov (United States)

    Terao, Takeshi; Ishida, Atsuko; Kimura, Toshifumi; Yoshida, Mitsuhiro; Hara, Terufumi

    2017-01-01

    Background A post-marketing surveillance (PMS) study was conducted with a 1-year observation period to assess the safety and efficacy of lamotrigine in routine clinical practice in patients with bipolar disorder (BD). Patients and methods Central enrollment method was used to recruit patients diagnosed with BD who were being treated for the first time with lamotrigine to prevent the recurrence/relapse of BD mood episodes. Adverse drug reactions (ADRs) and recurrence/relapse were assessed. Improvement of mania and depression was also assessed using the Hamilton’s Rating Scale for Depression (HAM-D) and the Young Mania Rating Scale (YMRS) at treatment initiation, 4–6 months post treatment initiation, and 10–12 months post treatment initiation. Results A total of 237/989 patients (24.0%) reported ADRs, most commonly rash (9.1%), and the incidence of serious ADRs was 3.3% (33/989 patients). Skin disorders occurred in 130 patients (13.1%), mostly within 8 weeks post treatment. A total of 237/703 patients (33.7%) experienced recurrence/relapse of mood episodes. The 25th percentile of the time to recurrence/relapse of mood episodes was 105 days. Remission of depression symptoms (HAM-D ≤7) occurred in 147/697 patients (21.1%) at treatment initiation, rising to 361 patients (67.4%) at 10–12 months post treatment. Remission of manic symptoms (YMRS ≤13) occurred in 615/676 patients (91.0%) at treatment initiation, rising to 500 patients (97.3%) at 10–12 months post treatment. Conclusion The results of this PMS study suggest that lamotrigine is a well-tolerated and effective drug for preventing recurrence/relapse of BD in clinical practice. PMID:28652744

  9. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese patients with osteoporosis: interim report.

    Science.gov (United States)

    Saito, Hitoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Yatomi, Sawako; Nihojima, Shigeru; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2017-07-01

    This large-scale post-marketing surveillance study was conducted to assess the safety and effectiveness of eldecalcitol treatment in patients with osteoporosis in a Japanese clinical setting. A total of 3567 patients with osteoporosis were enrolled and received eldecalcitol 0.75 μg/day for 12 months. For this interim report, 3285 patients were eligible for analysis. Mean age was 74.9 ± 8.7 years; 86.8 % (2854/3285) were women. There were 142 reported adverse drug reactions (ADRs) in 129 patients (3.92 % of the total 3285 patients): the most common were hypercalcemia and increased blood calcium (0.88 %), renal impairment (0.27 %), abdominal discomfort (0.24 %), constipation (0.24 %), and pruritus (0.24 %). The incidence of ADRs was 5.10 % in men and 3.74 % in women. Although 10 serious ADRs were reported in 9 patients (0.27 %), no clinically significant safety issues were identified. Incidence of hypercalcemia or increased blood calcium was 8.47 % in patients with renal impairment and only 0.74 % in patients without renal impairment. At last observation, the incidence of new vertebral and nonvertebral fractures was 2.44 % and 1.70 %, respectively. There was a significant increase in bone mineral density at the lumbar spine and distal radius. The bone turnover markers BAP, serum NTX, urinary NTX, and TRACP-5b were suppressed by eldecalcitol treatment in both sexes. In conclusion, consistent with the findings of the phase III pivotal clinical trial, eldecalcitol was shown to have a favorable safety profile and effectiveness in Japanese patients with osteoporosis. However, periodic measurements of serum calcium were required to prevent occurrence of hypercalcemia during eldecalcitol treatment, especially in patients with renal impairment.

  10. Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection.

    Science.gov (United States)

    Xu, Rong; Wang, QuanQiu

    2014-01-15

    Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance.

  11. Safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus: a 1-year post-marketing surveillance in Japan.

    Science.gov (United States)

    Goda, Maki; Yamakura, Tomoko; Sasaki, Kazuyo; Tajima, Takumi; Ueno, Makoto

    2018-02-01

    To evaluate the safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus (T2DM) in clinical settings. The authors conducted a 1-year post-marketing surveillance (PMS) of canagliflozin in almost all the elderly patients (≥65 years old) with T2DM who began taking canagliflozin during the first 3 months after its launch in Japan. The main outcomes included the incidences of adverse drug reactions (ADRs), serious ADRs, and the changes of laboratory tests as well as efficacy variables. An ADR was reported in 9.09% (125 of 1375 patients) in the safety analysis set. The main ADRs were dehydration, constipation, thirst, pollakiuria, dizziness, cystitis, eczema, pruritus, and rash. The incidence of serious ADRs was 1.02% (14 patients), which included urinary tract infection, dehydration, hypoglycemia, and cerebral infarction (two patients each). ADRs of special interest that had been reported in clinical trials of SGLT2 inhibitors, such as hypoglycemia, volume depletion-related events, genital/urinary tract infection, polyuria/pollakiuria, and ketone body increased were also observed in this PMS. The safety profiles were similar to the results of a previous clinical study of canagliflozin, and new safety concerns were not identified in this survey. The mean change in HbA1c was -0.77% after 12 months of treatment in the efficacy analysis set. In this PMS, the safety and efficacy profiles of canagliflozin in elderly patients with T2DM were obtained in the clinical settings in Japan and the drug was well tolerated and effective in improving glycemic control.

  12. Palivizumab Prophylaxis Against Respiratory Syncytial Virus Infection in Children with Immunocompromised Conditions or Down Syndrome: A Multicenter, Post-Marketing Surveillance in Japan.

    Science.gov (United States)

    Kashiwagi, Tomoko; Okada, Yukiko; Nomoto, Ken

    2018-02-01

    The aim of this study was to assess the safety and effectiveness of palivizumab for the prevention of lower respiratory tract infection (LRI) caused by respiratory syncytial virus (RSV) in children with immunocompromised conditions or Down syndrome. In this multicenter, post-marketing surveillance study (December 2013 to December 2015), children aged ≤24 months with immunocompromised conditions or Down syndrome (without hemodynamically significant congenital heart disease) receiving palivizumab immunoprophylaxis during two RSV seasons were observed until 30 days after the final palivizumab injection. Safety [adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs)] and effectiveness (frequency, incidence, and duration of hospitalization due to RSV infections) were assessed. Of 304 patients receiving palivizumab, 167 (54.9%) had immunocompromised conditions, and 138 (45.4%) had Down syndrome; 260 (85.5%) completed palivizumab immunoprophylaxis. The annual mean (±standard deviation) number of doses was 5.3 (±2.4) per season. Overall, 220 AEs occurred in 99 patients (32.6%), including 89 SAEs in 53 patients (17.4%). Of these, 33 AEs in 25 patients (8.22%) were considered ADRs, and 13 ADRs in 11 patients (3.62%) were considered SADRs. In four patients, five SADRs (nephroblastoma and asthma in the same patient, septic shock, device-related infection, and drug-induced liver injury) were previously unreported; however, none were considered drug-related. During the observation period, five RSV infections occurred and two patients required hospitalization. Palivizumab was generally safe and effective for the prevention of LRI caused by RSV in newborns, infants, and children with immunocompromised conditions or Down syndrome up to the age of 24 months.

  13. A multicenter post-marketing evaluation of the Elixir DESolve®Novolimus-eluting bioresorbable coronary scaffold system: First results from the DESolve PMCF study.

    Science.gov (United States)

    Nef, Holger; Wiebe, Jens; Boeder, Niklas; Dörr, Oliver; Bauer, Timm; Hauptmann, Karl-Eugen; Latib, Azeem; Colombo, Antonio; Fischer, Dieter; Rudolph, Tanja; Foin, Nicolas; Richardt, Gert; Hamm, Christian

    2018-03-06

    To date, experience with bioresorbable scaffolds (BRS) that elute agents other than everolimus is limited. Thus, a post-marketing clinical follow-up study was conducted to evaluate the continued safety and effectiveness of the DESolve® NOVOLIMUS™ Eluting BRS as treatment for patients with stable coronary artery disease. The DESolve BRS combines a poly-l-lactide-based backbone with a biodegradable polylactide-based polymer and Novolimus, a macrocyclic lactone mTOR inhibitor. One hundred and two patients (mean age 62 years, 77.5% male) were enrolled at 10 European sites. Comparison of baseline and post-procedural angiographic assessment was performed, and a device-oriented composite endpoint (comprising cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) and rate of scaffold thrombosis at 12 months were examined. The device was successfully delivered and deployed in 98.2% (107/109) of the lesions, with two failures to cross the lesion. A total of 100 patients (109 lesions) were treated with a DESolve BRS. Post-procedural angiographic assessment indicated an in-scaffold acute gain of 1.54 ± 0.44 mm, with a reduction in % diameter stenosis from 61.00 ± 11.29 to 12.69 ± 0.44. At 12 months, the device-oriented composite endpoint had occurred in 3.0% (3/100) of patients, with 1.0% (1/100) experiencing scaffold thrombosis and myocardial infarction and 3.0% (3/100) undergoing target lesion revascularization. There were no cardiac deaths. Results through 12 months indicate that the DESolve BRS is a safe and effective treatment for coronary lesions, though larger, long-term prospective studies are needed. © 2018 Wiley Periodicals, Inc.

  14. The real-life safety and efficacy of vardenafil: an international post-marketing surveillance study of 2824 patients from the Middle East.

    Science.gov (United States)

    Kamel, A; Khaouli, R; Sabha, M; Al Mitwally, K; Fouad, W; Landen, H

    2007-01-01

    To assess the safety, efficacy and patient acceptability of vardenafil treatment under real-life conditions in patients with erectile dysfunction (ED). The present publication shows the results of a subgroup analysis of a multinational post-marketing surveillance study, including 2824 Middle East patients with ED whose attending physician chose vardenafil as the most appropriate therapy. Patients were assessed at an initial visit for demographic and baseline characteristics. At one or two follow-up visits, covering a period of approximately 2 months or eight vardenafil intakes, patients were interviewed about overall treatment success (general improvement of erection, number of tablets taken until improvement, patient's satisfaction with overall efficacy and tolerability, comparison with last ED treatment). All adverse events were recorded and assessed for a possible relationship to treatment, and for severity. An overall improvement in erections was reported in 94.3% of patients. Most patients achieved treatment success after the first (67.0%) or second (83.6% cumulative) tablet. Diabetic patients had a similar improvement rate (92.2%) and 73.5% of patients who had undergone radical prostatectomy reported an overall improvement. The rate of adverse drug reactions (ADRs) was low (9.1% of patients). The most common ADRs were headache (5.8%), flushing (1.6%), nasal congestion (1.0%), dyspepsia (0.6%) and nausea (0.5%). In total, 88.9% of patients wanted to continue treatment with vardenafil. Vardenafil was effective, reliable and well tolerated in patients with ED treated under real-life conditions.

  15. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study.

    Science.gov (United States)

    Gory, Benjamin; Blanc, Raphaël; Turjman, Francis; Berge, Jérôme; Piotin, Michel

    2018-02-02

    The Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up. The Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond-Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months. Twenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19). This prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms. REGISTERED CLINICAL TRIAL: NCT02125097;Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  16. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

    Science.gov (United States)

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-10-02

    According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice.

  17. An approach to product selection for insomnia | Smith | South African ...

    African Journals Online (AJOL)

    . This condition can range from being mild to severe, depending on how often it occurs, and for how long. The main focus of treatment for insomnia should be directed towards finding the underlying cause. Once a cause is identified, it is ...

  18. Sleep board review question: insomnia in obstructive sleep apnea

    Directory of Open Access Journals (Sweden)

    Budhiraja R

    2013-11-01

    Full Text Available No abstract available. Article truncated after first page. What is the estimated prevalence of insomnia symptoms in patients with obstructive sleep apnea? 1. Less than 1% 2. 5%-10% 3. 20-30% 4. 40%-60% 5. Greater than 80%

  19. Increased use-dependent plasticity in chronic insomnia.

    Science.gov (United States)

    Salas, Rachel E; Galea, Joseph M; Gamaldo, Alyssa A; Gamaldo, Charlene E; Allen, Richard P; Smith, Michael T; Cantarero, Gabriela; Lam, Barbara D; Celnik, Pablo A

    2014-03-01

    During normal sleep several neuroplasticity changes occur, some of which are considered to be fundamental to strengthen memories. Given the evidence linking sleep to neuroplasticity, it is conceivable that individuals with chronic sleep disruption, such as patients with chronic insomnia (CI), would experience abnormalities in neuroplastic processes during daytime. Protocols testing use-dependent plasticity (UDP), one of the mechanisms underlying formation of motor memories traces, provide a sensitive measure to assess neuroplasticity in the context of motor training. A well-established transcranial magnetic stimulation (TMS) paradigm was used to evaluate the ability of patients with CI and age-matched good sleeper controls to undergo UDP. We also investigated the effect of insomnia on intracortical motor excitability measures reflecting GABAergic and glutamatergic mechanisms. Human Brain Physiology Laboratory, Johns Hopkins Medical Institutions. We found that patients with CI experienced increased UDP changes relative to controls. This effect was not due to differences in motor training. In addition, patients with CI showed enhanced intracortical facilitation relative to controls, in the absence of changes in intracortical inhibitory measures. This study provides the first evidence that patients with chronic insomnia have an increased plasticity response to physical exercise, possibly due to larger activation of glutamatergic mechanisms. This suggests a heightened state of neuroplasticity, which may reflect a form of maladaptive plasticity, similar to what has been described in dystonia patients and chronic phantom pain after amputation. These results could lead to development of novel treatments for chronic insomnia.

  20. Identification of new molecular alterations in Fatal Familial Insomnia.

    Science.gov (United States)

    Fatal familial insomnia (FFI) is an autosomal dominant prion disease caused by a D178N mutation in PRNP in combination with methionine (Met) at codon 129 in the mutated allele of the same gene (D178N-129M haplotype). The present study analyzes pathological and molecular features in seven FFI cases c...

  1. Orexin receptor antagonists as therapeutic agents for insomnia

    Directory of Open Access Journals (Sweden)

    Ana Clementina Equihua

    2013-12-01

    Full Text Available Insomnia is a common clinical condition characterized by difficulty initiating or maintaining sleep, or non-restorative sleep with impairment of daytime functioning.Currently, treatment for insomnia involves a combination of cognitive behavioral therapy and pharmacological therapy. Among pharmacological interventions, the most evidence exists for benzodiazepine receptor agonist drugs (GABAA receptor, although concerns persist regarding their safety and their limited efficacy. The use of these hypnotic medications must be carefully monitored for adverse effects.Orexin (hypocretin neuropeptides have been shown to regulate transitions between wakefulness and sleep by promoting cholinergic/monoaminergic neural pathways. This has led to the development of a new class of pharmacological agents that antagonize the physiological effects of orexin. The development of these agents may lead to novel therapies for insomnia without the side effect profile of hypnotics (e.g. impaired cognition, disturbed arousal, and motor balance difficulties. However, antagonizing a system that regulates the sleep-wake cycle may create an entirely different side effect profile. In this review, we discuss the role of orexin and its receptors on the sleep-wake cycle and that of orexin antagonists in the treatment of insomnia.

  2. Insomnia in central neurologic diseases--occurrence and management

    DEFF Research Database (Denmark)

    Mayer, Geert; Jennum, Poul; Riemann, Dieter

    2011-01-01

    associated with most of the central neurological diseases. The prevalence and treatment of insomnia in neurological diseases still need to be studied in larger patient groups with randomized clinical trials to a) better understand their impact and causal relationship and b) to develop and improve specific...

  3. The association between insomnia and perceived health status

    NARCIS (Netherlands)

    Donners, A.; Bury, D.; Fernstrand, A.; Garssen, J.; Roth, T.; Verster, J.

    2015-01-01

    Introduction: Impaired sleep can have a significant impact on perceived health status. The aim of the current study was to examine the relationship between perceived health status and sleep quality, total sleep time, and insomnia. Materials and methods: A survey was conducted among Dutch university

  4. A review of drug therapy for sporadic fatal insomnia.

    Science.gov (United States)

    Tabaee Damavandi, Pardis; Dove, Martin T; Pickersgill, Richard W

    2017-09-03

    Sporadic fatal insomnia (sFI) is a rapid progressive neurodegenerative disease characterised by gradual to perpetual insomnia, followed by dysautonomia, coma and death. 1 The cause of sFI was recently mapped to a mutation in a protein, the prion, found in the human brain. It is the unfolding of the prion that leads to the generation of toxic oligomers that destroy brain tissue and function. Recent studies have confirmed that a methionine mutation at codon 129 of the human Prion is characteristic of sFI. Current treatment slows down the progression of the disease, but no cure has been found, yet. We used Molecular Docking and Molecular Dynamics simulation methods, to study the toxic Fatal-Insomnia-prion conformations at local unfolding. The idea was to determine these sites and to stabilise these regions against unfolding and miss-folding, using a small ligand, based on a phenothiazine "moiety". As a result we here discuss current fatal insomnia therapy and present seven novel possible compounds for in vitro and in vivo screening.

  5. Reduced anterior internal capsule white matter integrity in primary insomnia.

    Science.gov (United States)

    Spiegelhalder, Kai; Regen, Wolfram; Prem, Martin; Baglioni, Chiara; Nissen, Christoph; Feige, Bernd; Schnell, Susanne; Kiselev, Valerij G; Hennig, Jürgen; Riemann, Dieter

    2014-07-01

    Chronic insomnia is one of the most prevalent central nervous system diseases, however, its neurobiology is poorly understood. Up to now, nothing is known about the integrity of white matter tracts in insomnia patients. In this study, diffusion tensor imaging (DTI) was used in a well-characterized sample of primary insomnia (PI) patients and good sleeper controls to fill this void. Voxelwise between-group comparisons of fractional anisotropy (FA) were performed in 24 PI patients (10 males; 14 females; 42.7 ± 14.5 years) and 35 healthy good sleepers (15 males; 20 females; 40.1 ± 9.1 years) with age and sex as covariates. PI patients showed reduced FA values within the right anterior internal capsule and a trend for reduced FA values in the left anterior internal capsule. The results suggest that insomnia is associated with a reduced integrity of white matter tracts in the anterior internal capsule indicating that disturbed fronto-subcortical connectivity may be a cause or consequence of the disorder.

  6. Chronic Insomnia: Clinical and Research Challenges - An Agenda

    NARCIS (Netherlands)

    Riemann, D.; Spiegelhalder, K.; Espie, C.; Pollmacher, T.; Leger, D.; Bassetti, C.; van Someren, E.J.W.

    2011-01-01

    Chronic insomnia afflicts up to 10% of the population in Western industrialized countries. It is characterized by delayed sleep onset, problems in maintaining sleep, early morning awakening or the feeling of non-restorative sleep coupled with significant daytime impairments on an emotional, social

  7. Ramelteon for the treatment of insomnia in menopausal women.

    Science.gov (United States)

    Dobkin, Roseanne DeFronzo; Menza, Matthew; Bienfait, Karina L; Allen, Lesley A; Marin, Humberto; Gara, Michael A

    2009-03-01

    Sleep disturbances have been reported to be one of the most troubling manifestations of menopause. While hormone replacement therapy (HRT) has historically been considered a first-line treatment for menopausal insomnia, many women are now seeking alternative treatments due to concerns about the risks and side-effects of HRT. The goal of this study was to evaluate the effect of ramelteon, a selective melatonin receptor agonist, for the treatment of menopausal insomnia. A total of 20 healthy peri- and postmenopausal women with insomnia participated in this six-week, prospective, open-label trial of ramelteon (8 mg) at an academic medical centre. Participants completed sleep-wake diaries on a daily basis for six weeks. Self-report measures of sleep impairment, daytime functioning, quality of life and mood were also completed on a bi-weekly basis. Significant improvements in latency to sleep onset, total sleep time and sleep efficiency were observed in diary data while gains in sleep quality, sleep impairment, daytime functioning, quality of life and mood were found in self-report measures. There was no evidence of tolerance or rebound over the course of the trial. Overall, results suggest that ramelteon is an effective non-hormonal approach for the treatment of insomnia in menopause. Randomized-controlled trials are needed to further evaluate the efficacy of this intervention.

  8. Evaluating DSM-5 Insomnia Disorder and the Treatment of Sleep Problems in a Psychiatric Population

    Science.gov (United States)

    Seow, Lee Seng Esmond; Verma, Swapna Kamal; Mok, Yee Ming; Kumar, Sunita; Chang, Sherilyn; Satghare, Pratika; Hombali, Aditi; Vaingankar, Janhavi; Chong, Siow Ann; Subramaniam, Mythily

    2018-01-01

    Study Objectives: With the introduction of insomnia disorder in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), greater emphasis has been placed on the diagnosis and treatment of sleep disorder even in the presence of a coexisting mental disorder. The current study seeks to explore the clinical picture of insomnia in the context of psychiatric disorders commonly associated with sleep complaints by assessing the prevalence and correlates of DSM-5 insomnia disorder, and examining the extent to which insomnia symptoms have been addressed in this population. Methods: Four hundred treatment-seeking outpatients suffering from depressive, bipolar affective, anxiety, and schizophrenia spectrum disorders were recruited. DSM-5 insomnia was established using the modified Brief Insomnia Questionnaire. Differences in sociodemographic factors, clinical status, impairment outcomes, and mental health services utilization were compared. Information on patients' help-seeking experiences for insomnia-related symptoms was collected to determine the treatment received and treatment effectiveness. Results: Almost one-third of our sample (31.8%) had DSM-5 insomnia disorder. Those with insomnia disorder had significantly higher impairment outcomes than their counterparts but no group difference was observed for mental health services utilization. Findings based on past treatment contact for sleep problems suggest that diagnosis and treatment of insomnia is lacking in this population. Conclusions: With the new calling from DSM-5, clinicians treating psychiatric patients should view insomnia less as a symptom of their mental illnesses and treat clinical insomnia as a primary disorder. Patients should also be educated on the importance of reporting and treating their sleep complaints. Nonmedical (cognitive and behavioral) interventions for insomnia need to be further explored given their proven clinical effectiveness. Citation: Seow LSE, Verma SK, Mok YM, Kumar

  9. Insomnia Severity Index: psychometric properties with Chinese community-dwelling older people.

    Science.gov (United States)

    Yu, Doris S F

    2010-10-01

    This paper is a report of a study to evaluate the psychometric properties of the Chinese version of the Insomnia Severity Index. Despite the high prevalence of insomnia in older people and its detrimental impact on well-being and healthcare costs, this problem is almost always undetected and consequently under-treated. The Insomnia Severity Index is psychometrically sound in measuring perceived insomnia severity. However, it has had very limited application in non-White populations. An instrument validation study was carried out between October 2008 and April 2009. The Insomnia Severity Index was translated into Chinese using Brislin's model and administered to a convenience sample of 585 older Chinese people recruited from three community centres for elders. Other instruments were also administered, including the Chinese version of the Pittsburgh Sleep Quality Index and the Geriatric Depression Scale. Cronbach's alpha of the Chinese version of the Insomnia Severity Index was 0.81, with item-to-total correlations in the range of 0.34-0.67. Construct validity was supported by its moderate relationship with the Chinese Pittsburgh Sleep Quality Index and sleep efficiency. The Chinese version of the Insomnia Severity Index also indicated more severe level of insomnia in older people who reported depressed mood on the Geriatric Depression Scale. Discriminant validity was supported as the Chinese version of the Insomnia Severity Index could discriminate poorer sleepers from normal sleepers. Exploratory factor analysis identified a two-factor structure for the Chinese version of the Insomnia Severity Index in measuring the severity and impacts of insomnia on the Chinese older people. The Chinese version of the Insomnia Severity Index is a culturally-relevant and psychometrically-sound instrument for assessing severity and impact of insomnia in Chinese community-dwelling older people. Nurses can use this tool to assess older people's perceptions of insomnia. © 2010 The

  10. Can insomnia in pregnancy predict postpartum depression? A longitudinal, population-based study.

    Directory of Open Access Journals (Sweden)

    Signe K Dørheim

    Full Text Available BACKGROUND: Insomnia and depression are strongly interrelated. This study aimed to describe changes in sleep across childbirth, and to evaluate whether insomnia in pregnancy is a predictor of postpartum depression. METHODS: A longitudinal, population-based study was conducted among perinatal women giving birth at Akershus University Hospital, Norway. Women received questionnaires in weeks 17 and 32 of pregnancy and eight weeks postpartum. This paper presents data from 2,088 of 4,662 women with complete data for insomnia and depression in week 32 of pregnancy and eight weeks postpartum. Sleep times, wake-up times and average sleep durations were self-reported. The Bergen Insomnia Scale (BIS was used to measure insomnia. The Edinburgh Postnatal Depression Scale (EPDS was used to measure depressive symptoms. RESULTS: After delivery, sleep duration was reduced by 49 minutes (to 6.5 hours, and mean sleep efficiency was reduced from 84% to 75%. However, self-reported insomnia scores (BIS improved from 17.2 to 15.4, and the reported prevalence of insomnia decreased from 61.6% to 53.8%. High EPDS scores and anxiety in pregnancy, fear of delivery, previous depression, primiparity, and higher educational level were risk factors for both postpartum insomnia and depression. Insomnia did not predict postpartum depression in women with no prior history of depression, whereas women who recovered from depression had residual insomnia. LIMITATIONS: Depression and insomnia were not verified by clinical interviews. Women with depressive symptoms were less likely to remain in the study. CONCLUSIONS: Although women slept fewer hours at night after delivery compared to during late pregnancy, and reported more nights with nighttime awakenings, their self-reported insomnia scores improved, and the prevalence of insomnia according to the DSM-IV criteria decreased. Insomnia in pregnancy may be a marker for postpartum recurrence of depression among women with previous

  11. Can Insomnia in Pregnancy Predict Postpartum Depression? A Longitudinal, Population-Based Study

    Science.gov (United States)

    Dørheim, Signe K.; Bjorvatn, Bjørn; Eberhard-Gran, Malin

    2014-01-01

    Background Insomnia and depression are strongly interrelated. This study aimed to describe changes in sleep across childbirth, and to evaluate whether insomnia in pregnancy is a predictor of postpartum depression. Methods A longitudinal, population-based study was conducted among perinatal women giving birth at Akershus University Hospital, Norway. Women received questionnaires in weeks 17 and 32 of pregnancy and eight weeks postpartum. This paper presents data from 2,088 of 4,662 women with complete data for insomnia and depression in week 32 of pregnancy and eight weeks postpartum. Sleep times, wake-up times and average sleep durations were self-reported. The Bergen Insomnia Scale (BIS) was used to measure insomnia. The Edinburgh Postnatal Depression Scale (EPDS) was used to measure depressive symptoms. Results After delivery, sleep duration was reduced by 49 minutes (to 6.5 hours), and mean sleep efficiency was reduced from 84% to 75%. However, self-reported insomnia scores (BIS) improved from 17.2 to 15.4, and the reported prevalence of insomnia decreased from 61.6% to 53.8%. High EPDS scores and anxiety in pregnancy, fear of delivery, previous depression, primiparity, and higher educational level were risk factors for both postpartum insomnia and depression. Insomnia did not predict postpartum depression in women with no prior history of depression, whereas women who recovered from depression had residual insomnia. Limitations Depression and insomnia were not verified by clinical interviews. Women with depressive symptoms were less likely to remain in the study. Conclusions Although women slept fewer hours at night after delivery compared to during late pregnancy, and reported more nights with nighttime awakenings, their self-reported insomnia scores improved, and the prevalence of insomnia according to the DSM-IV criteria decreased. Insomnia in pregnancy may be a marker for postpartum recurrence of depression among women with previous depression. PMID

  12. Insomnia is a frequent finding in adults with Asperger syndrome

    Science.gov (United States)

    Tani, Pekka; Lindberg, Nina; Nieminen-von Wendt, Taina; von Wendt, Lennart; Alanko, Lauri; Appelberg, Björn; Porkka-Heiskanen, Tarja

    2003-01-01

    Background Asperger syndrome (AS) is a neurodevelopmental disorder belonging to autism spectrum disorders with prevalence rate of 0,35% in school-age children. It has been most extensively studied in childhood while there is scarcity of reports concerning adulthood of AS subjects despite the lifelong nature of this syndrome. In children with Asperger syndrome the initiation and continuity of sleep is disturbed because of the neuropsychiatric deficits inherent of AS. It is probable that sleep difficulties are present in adulthood as well. Our hypothesis was that adults with AS suffer from difficulty in initiating and maintaining sleep and nonrestorative sleep (insomnia). Methods 20 AS without medication were compared with 10 healthy controls devoid of neuropsychiatric anamnesis. Clinical examination, blood test battery and head MRI excluded confounding somatic illnesses. Structured psychiatric interview for axis-I and axis-II disorders were given to both groups as well as Beck Depression Inventory and Wechsler adult intelligence scale, revised version. Sleep quality was assessed with sleep questionnaire, sleep diary during 6 consecutive days and description of possible sleep problems by the participants own words was requested. Results compared with controls and with normative values of good sleep, AS adults had frequent insomnia. In sleep questionnaire 90% (18/20), in sleep diary 75% (15/20) and in free description 85% (17/20) displayed insomnia. There was a substantial psychiatric comorbidity with only 4 AS subject devoid of other axis-I or axis-II disorders besides AS. Also these persons displayed insomnia. It can be noted that the distribution of psychiatric diagnoses in AS subjects was virtually similar to that found among patient with chronic insomnia. Conclusions the neuropsychiatric deficits inherent of AS predispose both to insomnia and to anxiety and mood disorders. Therefore a careful assessment of sleep quality should be an integral part of the treatment

  13. Insomnia is a frequent finding in adults with Asperger syndrome

    Directory of Open Access Journals (Sweden)

    von Wendt Lennart

    2003-10-01

    Full Text Available Abstract Background Asperger syndrome (AS is a neurodevelopmental disorder belonging to autism spectrum disorders with prevalence rate of 0,35% in school-age children. It has been most extensively studied in childhood while there is scarcity of reports concerning adulthood of AS subjects despite the lifelong nature of this syndrome. In children with Asperger syndrome the initiation and continuity of sleep is disturbed because of the neuropsychiatric deficits inherent of AS. It is probable that sleep difficulties are present in adulthood as well. Our hypothesis was that adults with AS suffer from difficulty in initiating and maintaining sleep and nonrestorative sleep (insomnia. Methods 20 AS without medication were compared with 10 healthy controls devoid of neuropsychiatric anamnesis. Clinical examination, blood test battery and head MRI excluded confounding somatic illnesses. Structured psychiatric interview for axis-I and axis-II disorders were given to both groups as well as Beck Depression Inventory and Wechsler adult intelligence scale, revised version. Sleep quality was assessed with sleep questionnaire, sleep diary during 6 consecutive days and description of possible sleep problems by the participants own words was requested. Results compared with controls and with normative values of good sleep, AS adults had frequent insomnia. In sleep questionnaire 90% (18/20, in sleep diary 75% (15/20 and in free description 85% (17/20 displayed insomnia. There was a substantial psychiatric comorbidity with only 4 AS subject devoid of other axis-I or axis-II disorders besides AS. Also these persons displayed insomnia. It can be noted that the distribution of psychiatric diagnoses in AS subjects was virtually similar to that found among patient with chronic insomnia. Conclusions the neuropsychiatric deficits inherent of AS predispose both to insomnia and to anxiety and mood disorders. Therefore a careful assessment of sleep quality should be an

  14. Monthly Fluctuations of Insomnia Symptoms in a Population-Based Sample

    Science.gov (United States)

    Morin, Charles M.; LeBlanc, M.; Ivers, H.; Bélanger, L.; Mérette, Chantal; Savard, Josée; Jarrin, Denise C.

    2014-01-01

    Study Objectives: To document the monthly changes in sleep/insomnia status over a 12-month period; to determine the optimal time intervals to reliably capture new incident cases and recurrent episodes of insomnia and the likelihood of its persistence over time. Design: Participants were 100 adults (mean age = 49.9 years; 66% women) randomly selected from a larger population-based sample enrolled in a longitudinal study of the natural history of insomnia. They completed 12 monthly telephone interviews assessing insomnia, use of sleep aids, stressful life events, and physical and mental health problems in the previous month. A total of 1,125 interviews of a potential 1,200 were completed. Based on data collected at each assessment, participants were classified into one of three subgroups: good sleepers, insomnia symptoms, and insomnia syndrome. Results: At baseline, 42 participants were classified as good sleepers, 34 met criteria for insomnia symptoms, and 24 for an insomnia syndrome. There were significant fluctuations of insomnia over time, with 66% of the participants changing sleep status at least once over the 12 monthly assessments (51.5% for good sleepers, 59.5% for insomnia syndrome, and 93.4% for insomnia symptoms). Changes of status were more frequent among individuals with insomnia symptoms at baseline (mean = 3.46, SD = 2.36) than among those initially classified as good sleepers (mean = 2.12, SD = 2.70). Among the subgroup with insomnia symptoms at baseline, 88.3% reported improved sleep (i.e., became good sleepers) at least once over the 12 monthly assessments compared to 27.7% whose sleep worsened (i.e., met criteria for an insomnia syndrome) during the same period. Among individuals classified as good sleepers at baseline, risks of developing insomnia symptoms and syndrome over the subsequent months were, respectively, 48.6% and 14.5%. Monthly assessment over an interval of 6 months was found most reliable to estimate incidence rates, while an

  15. Predictors of insomnia onset in adolescents in Japan.

    Science.gov (United States)

    Tokiya, Mikiko; Kaneita, Yoshitaka; Itani, Osamu; Jike, Maki; Ohida, Takashi

    2017-10-01

    The objective of this study was to clarify the incidence rate and predictive factors of insomnia in Japanese junior and senior high school students. We conducted a baseline survey on first year junior and senior high school students (seventh and 10th graders) throughout the nation. A follow-up survey was then conducted two years later. For both surveys, we used self-administered questionnaires inquiring about sleep, mental health status, lifestyle, participation in club activities, and study hours. A total of 3473 students (776 junior high and 2697 senior high) were suitable for analysis. During the two years leading to the follow-up study, the incidence rate of newly developed insomnia was 7.8% among junior high and 9.2% among senior high school students. Multiple logistic regression analyses revealed that factors associated with new insomnia onset were 'sleep paralysis experience' and 'poor mental health status' in junior high school students, and 'being woken by a nightmare', 'poor mental health status', '≥2 h of extracurricular learning per day' and 'mobile phone use for ≥2 h per day' in senior high school students. In junior and senior high school students, parasomnias such as nightmares and sleep paralysis, and mental health status can be predictors of insomnia onset. For senior high school students, longer use of mobile phones can be a predictor of insomnia onset. The present findings suggest that sleep health must be promoted among junior and senior high school students in the future. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. [Attitudes to insomnia by Primary Care physicians of Majorca (Spain)].

    Science.gov (United States)

    Torrens, Isabel; Ortuño, Marina; Guerra, Juan Ignacio; Esteva, Magdalena; Lorente, Patricia

    2016-01-01

    To describe the current clinical management of insomnia by family physicians. Cross-sectional study. Majorca Health Area, 2011-2012. Family physicians (FP). Paediatricians, resident physicians and emergency physicians were excluded. Using a self-administered questionnaire, the following variables were collected: social, demographic, professional, training in insomnia, prescription preferences, and its clinical management. A total of 322 of 435 physicians answered (74%), of whom 55% were female. The mean age was 48 years with a mean of 21 years in the profession. Most of them consider insomnia as a major health problem, and refer to asking patients about sleep habits and its impact on daily life. About one third have been trained in insomnia in the last 5 years. Very few (0.6%) refers patients to a psychiatrist, and 1.9% to a psychologist. The most prescribed drugs are benzodiazepines (33.4%) and Z drugs (25.7%), with 69.4% of them claiming to have checked the treatment after month of onset. Most refer to advice about sleep hygiene measures (85.1%), 15.1% prescribe herbal remedies, and 14.2% behavioural cognitive therapy (CBT). Seven out of ten physicians consider CBT as effective and applicable by both physicians and nurses. The older FPs prescribe benzodiazepines with less frequency, while female FPs prescribe more sleep hygiene measures and herbal remedies. Most FPs consider insomnia as a major health problem, in which they usually get involved. The most commonly used treatments are sleep hygiene advice, followed by benzodiazepines and Z drugs. The CBT is considered effective but not widely used. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  17. Monthly fluctuations of insomnia symptoms in a population-based sample.

    Science.gov (United States)

    Morin, Charles M; Leblanc, M; Ivers, H; Bélanger, L; Mérette, Chantal; Savard, Josée; Jarrin, Denise C

    2014-02-01

    To document the monthly changes in sleep/insomnia status over a 12-month period; to determine the optimal time intervals to reliably capture new incident cases and recurrent episodes of insomnia and the likelihood of its persistence over time. Participants were 100 adults (mean age = 49.9 years; 66% women) randomly selected from a larger population-based sample enrolled in a longitudinal study of the natural history of insomnia. They completed 12 monthly telephone interviews assessing insomnia, use of sleep aids, stressful life events, and physical and mental health problems in the previous month. A total of 1,125 interviews of a potential 1,200 were completed. Based on data collected at each assessment, participants were classified into one of three subgroups: good sleepers, insomnia symptoms, and insomnia syndrome. At baseline, 42 participants were classified as good sleepers, 34 met criteria for insomnia symptoms, and 24 for an insomnia syndrome. There were significant fluctuations of insomnia over time, with 66% of the participants changing sleep status at least once over the 12 monthly assessments (51.5% for good sleepers, 59.5% for insomnia syndrome, and 93.4% for insomnia symptoms). Changes of status were more frequent among individuals with insomnia symptoms at baseline (mean = 3.46, SD = 2.36) than among those initially classified as good sleepers (mean = 2.12, SD = 2.70). Among the subgroup with insomnia symptoms at baseline, 88.3% reported improved sleep (i.e., became good sleepers) at least once over the 12 monthly assessments compared to 27.7% whose sleep worsened (i.e., met criteria for an insomnia syndrome) during the same period. Among individuals classified as good sleepers at baseline, risks of developing insomnia symptoms and syndrome over the subsequent months were, respectively, 48.6% and 14.5%. Monthly assessment over an interval of 6 months was found most reliable to estimate incidence rates, while an interval of 3 months proved the most

  18. Cognitive and Behavioral Factors Associated With Insomnia in Inpatients With Schizophrenia and Related Psychoses.

    Science.gov (United States)

    Chiu, Vivian W; Harvey, Robert H; Sloan, Nancy B; Ree, Melissa; Lin, Ashleigh; Janca, Aleksandar; Waters, Flavie

    2015-10-01

    This study examines cognitive and behavioral factors linked to insomnia in individuals with schizophrenia and other psychotic disorders (with and without insomnia) and healthy controls (with and without insomnia). Fifty-five psychiatric inpatients and 66 healthy controls (n = 25 with insomnia in both groups) completed the Insomnia Severity Index, Thought Control Questionnaire for Insomnia-Revised, Dysfunctional Beliefs and Attitudes about Sleep scale, Sleep Hygiene Knowledge scale, and Beliefs about Causes of Sleep Problems questionnaires. Both insomnia groups demonstrated night-time rumination, aggressive suppression as a thought control strategy, and exaggerated views regarding the health consequences of poor sleep. In addition, the psychiatric group with insomnia frequently reported the causes of insomnia to be related to their illness (rather than to their lifestyle factors) and had an incomplete understanding of good sleep habits. Psychological interventions should be more commonly pursued as a first line of treatment for insomnia in schizophrenia and psychosis, and these should be adapted to address the unique knowledge gaps and cognitive style of patients.

  19. The evaluation of selected insomnia predictors in adolescents and young adults with cystic fibrosis.

    Science.gov (United States)

    Tomaszek, Lucyna; Cepuch, Grazyna; Pawlik, Lidia

    2018-03-21

    The purpose of the study was to assess the incidence of insomnia in adolescents and young adults with cystic fibrosis and its impact on the quality of life, and to examine whether demographic and clinical factors and negative emotional states are predictors of insomnia in these patients. The study was conducted among 95 cystic fibrosis patients aged 14-25 years. The study used a personal questionnaire survey, the Athens Insomnia Scale, the Cystic Fibrosis Quality of Life Questionnaire, the Hospital Anxiety and Depression Scale, and the Numeric Rating Scale. Insomnia was diagnosed in 38% of cystic fibrosis patients. In patients with insomnia, the level of anxiety (Me: 10 vs. 4; P=0.000) and depression (Me: 6.5 vs. 2; P=0.000) was significantly higher than in the good sleep quality group. The risk of insomnia increases as anxiety (OR: 4.31; 95% CI: 2.20 to 8.41) and depressive symptoms exacerbate (OR: 4.98; 95% CI: 1.84 to 13.43). Insomnia significantly worsens the quality of life in cystic fibrosis patients (ß =-0.5, P=0.000). Insomnia affects a large percentage of cystic fibrosis patients, and anxiety and depression are factors that increase the risk of insomnia. Insomnia decreases the quality of life in cystic fibrosis patients.

  20. Phenotypes of sleeplessness: stressing the need for psychodiagnostics in the assessment of insomnia.

    Science.gov (United States)

    van de Laar, Merijn; Leufkens, Tim; Bakker, Bart; Pevernagie, Dirk; Overeem, Sebastiaan

    2017-09-01

    Insomnia is a too general term for various subtypes that might have different etiologies and therefore require different types of treatment. In this explorative study we used cluster analysis to distinguish different phenotypes in 218 patients with insomnia, taking into account several factors including sleep variables and characteristics related to personality and psychiatric comorbidity. Three clusters emerged from the analysis. The 'moderate insomnia with low psychopathology'-cluster was characterized by relatively normal personality traits, as well as normal levels of anxiety and depressive symptoms in the presence of moderate insomnia severity. The 'severe insomnia with moderate psychopathology'-cluster showed relatively high scores on the Insomnia Severity Index and scores on the sleep log that were indicative for severe insomnia. Anxiety and depressive symptoms were slightly above the cut-off and they were characterized by below average self-sufficiency and less goal-directed behavior. The 'early onset insomnia with high psychopathology'-cluster showed a much younger age and earlier insomnia onset than the other two groups. Anxiety and depressive symptoms were well above the cut-off score and the group consisted of a higher percentage of subjects with comorbid psychiatric disorders. This cluster showed a 'typical psychiatric' personality profile. Our findings stress the need for psychodiagnostic procedures next to a sleep-related diagnostic approach, especially in the younger insomnia patients. Specific treatment suggestions are given based on the three phenotypes.

  1. Persistent insomnia: the role of objective short sleep duration and mental health.

    Science.gov (United States)

    Vgontzas, Alexandros N; Fernandez-Mendoza, Julio; Bixler, Edward O; Singareddy, Ravi; Shaffer, Michele L; Calhoun, Susan L; Liao, Duanping; Basta, Maria; Chrousos, George P

    2012-01-01

    Few population-based, longitudinal studies have examined risk factors for persistent insomnia, and the results are inconsistent. Furthermore, none of these studies have examined the role of polysomnographic (PSG) variables such as sleep duration or sleep apnea on the persistence of insomnia. Representative longitudinal study. Sleep laboratory. From a random, general population sample of 1741 individuals of the adult Penn State Cohort, 1395 were followed-up after 7.5 years. Individuals underwent one-night PSG and full medical evaluation at baseline and a telephone interview at follow-up. PSG sleep duration was analyzed as a continuous variable and as a categorical variable: insomnia persistence, partial remission, and full remission were 44.0%, 30.0%, and 26.0%, respectively. Objective short sleep duration significantly increased the odds of persistent insomnia as compared to normal sleep (OR = 3.19) and to fully remitted insomnia (OR = 4.92). Mental health problems at baseline were strongly associated with persistent insomnia as compared to normal sleep (OR = 9.67) and to a lesser degree compared to fully remitted insomnia (OR = 3.68). Smoking, caffeine, and alcohol consumption and sleep apnea did not predict persistent insomnia. Objective short sleep duration and mental health problems are the strongest predictors of persistent insomnia. These data further support the validity and clinical utility of objective short sleep duration as a novel marker of the biological severity of insomnia.

  2. Acute Pain and Depressive Symptoms: Independent Predictors of Insomnia Symptoms among Adults with Sickle Cell Disease.

    Science.gov (United States)

    Moscou-Jackson, Gyasi; Allen, Jerilyn; Kozachik, Sharon; Smith, Michael T; Budhathoki, Chakra; Haywood, Carlton

    2016-02-01

    No studies to date have systematically investigated insomnia symptoms among adults with sickle cell disease (SCD). The purpose of this study was to (1) describe the prevalence of insomnia symptoms and (2) identify biopsychosocial predictors in community-dwelling adults with SCD. Cross-sectional analysis of baseline data from 263 African American adults with SCD (aged 18 years or older). Measures included the Insomnia Severity Index (ISI), Center for Epidemiologic Studies in Depression scale, Urban Life Stress Scale, Brief Pain Inventory, and a chronic pain item. SCD genotype was extracted from the medical record. A slight majority (55%) of the sample reported clinically significant insomnia symptomatology (ISI ≥ 10), which suggests that insomnia symptoms are prevalent among community-dwelling African American adults with SCD. While insomnia symptoms were associated with a number of biopsychosocial characteristics, depressive symptoms and acute pain were the only independent predictors. Given the high number of participants reporting clinically significant insomnia symptoms, nurses should screen for insomnia symptoms and explore interventions to promote better sleep among adults with SCD, with an emphasis on recommending treatment for pain and depression. In addition, current pain and depression interventions in this population could add insomnia measures and assess the effect of the intervention on insomnia symptomatology as a secondary outcome. Copyright © 2016 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  3. Insomnia: zolpidem extended-release for the treatment of sleep induction and sleep maintenance symptoms.

    Science.gov (United States)

    Doghramji, Paul P

    2007-01-17

    Insomnia impairs daytime functioning or causes clinically significant daytime distress. The consequences of insomnia, if left untreated, may contribute to the risks of developing additional serious conditions, such as psychiatric illness, cardiovascular disease, or metabolic issues. Furthermore, some comorbidities associated with insomnia may be bidirectional in their causality because psychiatric and other medical problems can increase the risk for insomnia. Regardless of the serious consequences of inadequately treated insomnia, clinicians often do not inquire into their patients' sleep habits, and patients, in turn, are not forthcoming with details of their sleep difficulties. The continuing education of physicians and patients with regard to insomnia and currently available therapies for the treatment of insomnia is, therefore, essential. Insomnia may present as either a difficulty falling asleep, difficulty maintaining sleep, or waking too early without being able to return to sleep. Furthermore, these symptoms often change over time in an unpredictable manner. Therefore, when considering a sleep medication, one with efficacy for the treatment of multiple insomnia symptoms is recommended. A modified-release formulation of zolpidem, zolpidem extended-release, has been approved for the treatment of insomnia characterized by both difficulty in falling asleep and maintaining sleep. Here, we review studies supporting the use of zolpidem extended-release in the treatment of sleep-onset and sleep maintenance difficulties.

  4. Evaluating DSM-5 Insomnia Disorder and the Treatment of Sleep Problems in a Psychiatric Population.

    Science.gov (United States)

    Seow, Lee Seng Esmond; Verma, Swapna Kamal; Mok, Yee Ming; Kumar, Sunita; Chang, Sherilyn; Satghare, Pratika; Hombali, Aditi; Vaingankar, Janhavi; Chong, Siow Ann; Subramaniam, Mythily

    2018-02-15

    With the introduction of insomnia disorder in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), greater emphasis has been placed on the diagnosis and treatment of sleep disorder even in the presence of a coexisting mental disorder. The current study seeks to explore the clinical picture of insomnia in the context of psychiatric disorders commonly associated with sleep complaints by assessing the prevalence and correlates of DSM-5 insomnia disorder, and examining the extent to which insomnia symptoms have been addressed in this population. Four hundred treatment-seeking outpatients suffering from depressive, bipolar affective, anxiety, and schizophrenia spectrum disorders were recruited. DSM-5 insomnia was established using the modified Brief Insomnia Questionnaire. Differences in sociodemographic factors, clinical status, impairment outcomes, and mental health services utilization were compared. Information on patients' help-seeking experiences for insomnia-related symptoms was collected to determine the treatment received and treatment effectiveness. Almost one-third of our sample (31.8%) had DSM-5 insomnia disorder. Those with insomnia disorder had significantly higher impairment outcomes than their counterparts but no group difference was observed for mental health services utilization. Findings based on past treatment contact for sleep problems suggest that diagnosis and treatment of insomnia is lacking in this population. With the new calling from DSM-5, clinicians treating psychiatric patients should view insomnia less as a symptom of their mental illnesses and treat clinical insomnia as a primary disorder. Patients should also be educated on the importance of reporting and treating their sleep complaints. Nonmedical (cognitive and behavioral) interventions for insomnia need to be further explored given their proven clinical effectiveness. © 2018 American Academy of Sleep Medicine

  5. Neurobehavioral Performance Impairment in Insomnia: Relationships with Self-Reported Sleep and Daytime Functioning

    Science.gov (United States)

    Shekleton, Julia A.; Flynn-Evans, Erin E.; Miller, Belinda; Epstein, Lawrence J.; Kirsch, Douglas; Brogna, Lauren A.; Burke, Liza M.; Bremer, Erin; Murray, Jade M.; Gehrman, Philip; Lockley, Steven W.; Rajaratnam, Shantha M. W.

    2014-01-01

    Study Objectives: Despite the high prevalence of insomnia, daytime consequences of the disorder are poorly characterized. This study aimed to identify neurobehavioral impairments associated with insomnia, and to investigate relationships between these impairments and subjective ratings of sleep and daytime dysfunction. Design: Cross-sectional, multicenter study. Setting: Three sleep laboratories in the USA and Australia. Patients: Seventy-six individuals who met the Research Diagnostic Criteria (RDC) for Primary Insomnia, Psychophysiological Insomnia, Paradoxical Insomnia, and/or Idiopathic Childhood Insomnia (44F, 35.8 ± 12.0 years [mean ± SD]) and 20 healthy controls (14F, 34.8 ± 12.1 years). Interventions: N/A. Measurements and Results: Participants completed a 7-day sleep-wake diary, questionnaires assessing daytime dysfunction, and a neurobehavioral test battery every 60-180 minutes during an afternoon/evening sleep laboratory visit. Included were tasks assessing sustained and switching attention, working memory, subjective sleepiness, and effort. Switching attention and working memory were significantly worse in insomnia patients than controls, while no differences were found for simple or complex sustained attention tasks. Poorer sustained attention in the control, but not the insomnia group, was significantly associated with increased subjective sleepiness. In insomnia patients, poorer sustained attention performance was associated with reduced health-related quality of life and increased insomnia severity. Conclusions: We found that insomnia patients exhibit deficits in higher level neurobehavioral functioning, but not in basic attention. The findings indicate that neurobehavioral deficits in insomnia are due to neurobiological alterations, rather than sleepiness resulting from chronic sleep deficiency. Citation: Shekleton JA; Flynn-Evans EE; Miller B; Epstein LJ; Kirsch D; Brogna LA; Burke LM; Cremer E; Murray JM; Gehrman P; Lockley SW; Rajaratnam SMW

  6. Correlates of general quality of life are different in patients with primary insomnia as compared to patients with insomnia and psychiatric comorbidity

    NARCIS (Netherlands)

    Laar, M. van de; Pevernagie, D.; Mierlo, P. van; Overeem, S.

    2017-01-01

    Chronic insomnia is known to have a negative influence on quality of life (QOL). To date, most studies on chronic insomnia have focused on health-related aspects of QOL. General QOL, which is a different construct, has not been studied in detail. Moreover, it is not known which factors are

  7. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

    Science.gov (United States)

    Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

    2017-12-01

    Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

  8. Transdermal buprenorphine for the treatment of moderate to severe chronic pain: results from a large multicenter, non-interventional post-marketing study in Poland.

    Science.gov (United States)

    Przeklasa-Muszynska, Anna; Dobrogowski, Jan

    2011-06-01

    To evaluate the use of a buprenorphine transdermal patch (Transtec*) in routine clinical practice, including dosage, indications, efficacy and tolerability. This prospective, open-label, non-comparative, non-interventional, post-marketing study was performed in Poland by 339 investigators in a range of clinical practice settings. Patients with chronic moderate to severe cancer pain, or chronic severe non-cancer pain that was insufficiently controlled by non-opioids, were prescribed buprenorphine transdermal patch 35, 52.5 or 70 μg/hour (changed twice weekly), and followed up for 3 months. Additional analgesia, and adjuvant/supportive treatments were allowed at the discretion of the physician. The study enrolled 4030 patients, with a mean age of 62.8 years. Most patients had cancer-related pain (80.7%). Non-cancer pain was generally musculoskeletal or neuropathic. A starting dose of 35, 52.5 or 70 μg/hour was used in 73.4%, 21.5%, and 4.8% of patients, respectively. Buprenorphine dose was increased in 44.7% of patients during the observation, generally from 35 to 52.5 μg/hour. Mean pain intensity (using a 100 mm visual analogue scale) decreased by 73.5% from 62.3 mm at baseline to 16.5 mm after 3 months. Most patients rated pain relief as 'very good' (41.4%) or 'good' (44.5%). Sleep quality also improved. 48.1% of patients needed no additional analgesics during buprenorphine treatment. Most patients (96%) rated the buprenorphine transdermal patch as 'very easy' or 'easy' to change. The most common treatment-related reasons for discontinuation were lack of analgesic effect (3.3% of patients) and adverse drug reactions (ADRs, 0.8%). ADRs, all non-serious, occurred in 34 patients (0.8%), most commonly local skin reactions or vomiting. At study end, it was planned to continue treatment with transdermal buprenorphine in 70.1% of patients. The main limitations related to the observational study design, balanced by advantages gained from the 'real life

  9. Clinical evaluation of recombinant factor VIII preparation (Kogenate) in previously treated patients with hemophilia A: descriptive meta-analysis of post-marketing study data.

    Science.gov (United States)

    Yoshioka, A; Fukutake, K; Takamatsu, J; Shirahata, A

    2006-08-01

    The safety and efficacy of Kogenate, a recombinant factor VIII (rFVIII) preparation for the treatment of bleeding episodes, were studied in a 123-patient meta-analysis population of previously treated patients (PTPs), including 15 enrolled in the registration Phase III trial (PTP-I group), 93 from the post-marketing special investigation (PTP-II group), and 15 from short-term special investigations in surgery or tooth extraction (SI group). These patients (82 severe, 31 moderate, 9 mild, and 1 unknown), aged 11 months to 72 years, were enrolled in 28 centers in Japan. Blood samples taken at the baseline and at 3, 6, 9, 12, 18, and 24 months after the introduction of Kogenate were evaluated for FVIII inhibitor antibodies, antibodies formed against trace proteins derived from the rFVIII production process, and for general changes in laboratory test results. Mean exposure to Kogenate was 1103 days in PTP-I, 86 days in PTP-II, 27 days in patients in surgery, and 2 days in patients with tooth extraction. Assessment of FVIII inhibitor activity was conducted in 115 of the 123 patients by means of the Bethesda assay. Twelve patients were found to have a low titer of FVIII inhibitor (0.5-3.0 BU/mL) prior to any administration of Kogenate, and 103 were inhibitor-negative at the baseline. Among this latter group, 3 patients (2.9%) tested inhibitor-positive, with titers ranging from 1.2 to 2.1 BU/mL, with 4 patients below 1.0 BU/mL. One patient in the 11 PTPs investigated (PTP-I) developed antibodies against baby hamster kidney protein and mouse immunoglobulin G, but these findings were transient and asymptomatic. Hemostasis was achieved (markedly effective or effective) in 3666 of the 3855 bleeding episodes (95.1%) observed in 108 patients. Only 1 infusion was necessary in 3790 (98.3%) of these episodes. These data indicate that Kogenate is safe and very effective for the treatment of bleeding in PTPs with hemophilia A.

  10. Post-marketing surveillance on the long-term use of dabigatran in Japanese patients with nonvalvular atrial fibrillation: Preliminary report of the J-dabigatran surveillance.

    Science.gov (United States)

    Inoue, Hiroshi; Uchiyama, Shinichiro; Atarashi, Hirotsugu; Okumura, Ken; Koretsune, Yukihiro; Yasaka, Masahiro; Yamashita, Takeshi; Ohnishi, Makiko; Yagi, Nobutaka; Fukaya, Taku

    2016-04-01

    A post-marketing surveillance (PMS) study is being conducted to investigate the safety and effectiveness of the long-term use of dabigatran etexilate (dabigatran) in Japanese patients with nonvalvular atrial fibrillation (NVAF). Results of an interim analysis of this prospective cohort study including patient characteristics and adverse drug reactions (ADRs) collected up to September 17, 2014 are reported here. Patients with NVAF who began to receive dabigatran for the first time from December 2011 to November 2013 were enrolled at 1042 study sites in Japan. Clinical parameters included patient characteristics, dabigatran dose strength, concomitant medications and outcome events. All outcome events were collected as serious and non-serious adverse events (AEs). ADRs were evaluated in this report. Pre-defined safety events of special interest for intensive survey were serious and non-serious outcome events such as myocardial infarction, as well as the total number of hemorrhage and gastrointestinal disorders. A total of 6772 patients were registered. The safety analysis set included 6148 patients; mean age was 70.8±9.9 (SD) years: 2323 patients (37.8%) were aged 75 years or older. Males accounted for 66.8% of the patients. Mean CHADS2 score was 1.8±1.3; the CHADS2 score was 0 in 13.6%, 1 in 31.3%, 2 in 25.9%, 3 in 14.9%, and 4 to 6 in 11.1% of the patients. Of the 6148 patients, 1701 patients (27.7%) were switchers from warfarin and 4407 patients (71.7%) were non-switchers (OAC naïve patients). Treatment adherence was assessed for the first 3 months from the start of treatment for this analysis. Total 5656 patients (92.0%) reported taking dabigatran twice daily (bid) every day according to the label recommendation. During the follow up period [mean duration of follow up: 498±259 days (corresponding to 8386 patient-years)], pre-defined safety events of special interest for intensive survey (reported as serious ADRs) were: myocardial infarction, reported in 5

  11. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

    Science.gov (United States)

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.

  12. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing phase IV study

    Directory of Open Access Journals (Sweden)

    Bashaireh K

    2015-04-01

    Full Text Available Khaldoon Bashaireh,1 Ziad Naser,2 Khaled Al Hawadya,2 Sorour Sorour,2 Rami Nabeel Al-Khateeb3 1Department of Orthopedics Surgery, King Abdullah University Hospital, Jordan University of Science and Technology, Irbid, Jordan; 2Private Clinic, 3Elaf Medical Supplies Company, Amman, Jordan Purpose: The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period.Materials and methods: The study was a post-marketing phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1–4 in the tibio–femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection.Main outcome measure(s: An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated.Main results: The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3

  13. Manifestations of Insomnia in Sleep Apnea: Implications for Screening and Treatment.

    Science.gov (United States)

    Bailes, Sally; Rizzo, Dorrie; Baltzan, Marc; Grad, Roland; Pavilanis, Alan; Creti, Laura; Fichten, Catherine S; Libman, Eva

    2016-01-01

    The aims of this study were to examine the presence, type, and severity of insomnia complaints in obstructive sleep apnea (OSA) patients and to assess the utility of the Sleep Symptom Checklist (SSC) for case identification in primary care. Participants were 88 OSA patients, 57 cognitive-behavioral therapy for insomnia (CBT-I) patients, and 14 healthy controls (Ctrl). Each completed a sleep questionnaire as well as the SSC, which includes insomnia, daytime functioning, psychological, and sleep disorder subscales. Results showed that OSA patients could be grouped according to 3 insomnia patterns: no insomnia (OSA), n = 21; insomnia (OSA-I), n = 30, with a subjective complaint and disrupted sleep; and noncomplaining poor sleepers (OSA-I-NC), n = 37. Comparisons among the OSA, CBT-I, and Ctrl groups demonstrate distinct profiles on the SSC subscales, indicating its potential utility for both case identification and treatment planning.

  14. Alcohol Dependence and Its Relationship With Insomnia and Other Sleep Disorders.

    Science.gov (United States)

    Chakravorty, Subhajit; Chaudhary, Ninad S; Brower, Kirk J

    2016-11-01

    Sleep-related complaints are widely prevalent in those with alcohol dependence (AD). AD is associated not only with insomnia, but also with multiple sleep-related disorders as a growing body of literature has demonstrated. This article will review the various aspects of insomnia associated with AD. In addition, the association of AD with other sleep-related disorders will be briefly reviewed. The association of AD with insomnia is bidirectional in nature. The etiopathogenesis of insomnia has demonstrated multiple associations and is an active focus of research. Treatment with cognitive behavioral therapy for insomnia is showing promise as an optimal intervention. In addition, AD may be associated with circadian abnormalities, short sleep duration, obstructive sleep apnea, and sleep-related movement disorder. The burgeoning knowledge on insomnia associated with moderate-to-severe alcohol use disorder has expanded our understanding of its underlying neurobiology, clinical features, and treatment options. Copyright © 2016 by the Research Society on Alcoholism.

  15. Change in Job Strain as A Predictor of Change in Insomnia Symptoms

    DEFF Research Database (Denmark)

    Halonen, Jaana I.; Lallukka, Tea; Pentti, Jaana

    2017-01-01

    STUDY OBJECTIVES: To examine whether change in job strain lead to change in insomnia symptoms. METHODS: Among 24,873 adults (82% women, mean age 44 years) who participated in a minimum of three consecutive study waves (2000-2012), job strain was assessed at the first and second wave and insomnia...... symptoms at all three waves. We analyzed observational data as a "pseudo-trial" including participants with no job strain in the first wave and no insomnia symptoms in the first and second wave (n=7354) to examine whether the onset of job strain between the first and second waves predicted the onset...... of insomnia symptoms in the third wave. We used a corresponding approach, including those with job strain in the first wave and insomnia symptoms in the first and second wave (n=2332), to examine whether the disappearance of job strain between the first two waves predicted remission of insomnia symptoms...

  16. Family life stress and insomnia symptoms in a prospective evaluation of young adults.

    Science.gov (United States)

    Bernert, Rebecca A; Merrill, Katherine A; Braithwaite, Scott R; Van Orden, Kimberly A; Joiner, Thomas E

    2007-03-01

    The present study prospectively investigated the association between family life stress and insomnia symptoms among 115 undergraduates, ages 17-22 years. Participants completed the following questionnaires at 2 study time points, spaced 3 weeks apart: the Insomnia Severity Index, the Negative Life Events Questionnaire (NLEQ), and the Beck Depression Inventory. First, family life stress at baseline was hypothesized to predict elevated insomnia symptoms 3 weeks later, above and beyond depressive symptoms. Second, compared with academic stressors, negative family and social life events were expected to best predict increased insomnia. Regression analyses were conducted to test study predictions. Hypotheses were partially supported. Family life stress was significantly associated with increased insomnia symptomatology, even after controlling for depression. Results also revealed that negative family life events, together with academic stress, predicted the highest levels of insomnia.

  17. Mobile Devices and Insomnia: Understanding Risks and Benefits.

    Science.gov (United States)

    Khan, Mohammed N; Nock, Rebecca; Gooneratne, Nalaka S

    2015-12-01

    Mobile devices (smartphones and tablet computers) have become widely prevalent due to rapid improvements in function and decreasing costs. As of 2014, 90 % of US adults have a mobile phone, with 58 % having a smartphone, 32 % owning some type of e-reader, and 42 % of US adults owning a tablet computer. Mobile devices are particularly well-suited for the study of common conditions such as sleep difficulties because of their ubiquity. Around 35 to 49 % of the US adult population have problems falling asleep or have daytime sleepiness. These sleep disorders are often under-recognized because of patient-physician communication difficulties, low rates of medical awareness resulting in underreporting of insomnia symptoms, and limited primary care physician (PCP) training in insomnia recognition. Mobile devices have the potential to bridge some of these gaps, but they can also lead to sleep difficulties when used inappropriately.

  18. Ramelteon for insomnia in two youths with autistic disorder.

    Science.gov (United States)

    Stigler, Kimberly A; Posey, David J; McDougle, Christopher J

    2006-10-01

    The aim of this study was to report preliminary data on the effectiveness and tolerability of ramelteon for the treatment of insomnia in youth with autistic disorder (autism). Two youths, ages 7 and 18 years, with autism and significant insomnia characterized by problems with sleep onset and maintenance received an open-label trial of ramelteon (4-8 mg) over a duration of 16-18 weeks. Target symptoms of delayed sleep onset and/or frequent nocturnal awakening improved significantly, as determined by Clinical Global Impressions-Improvement (CGI-I) scale ratings of either "much improved" or "very much improved." Ramelteon was well tolerated. No daytime sedation was reported. This case report illustrates the potential effectiveness and tolerability of ramelteon for sleep disturbances in 2 patients with autism. Further research is needed to verify its safety, tolerability, and efficacy in children and adolescents with autism.

  19. Cranial electrotherapy stimulation for treatment of anxiety, depression, and insomnia.

    Science.gov (United States)

    Kirsch, Daniel L; Nichols, Francine

    2013-03-01

    Cranial electrotherapy stimulation is a prescriptive medical device that delivers a mild form of electrical stimulation to the brain for the treatment of anxiety, depression, and insomnia. It is supported by more than 40 years of research demonstrating its effectiveness in several mechanistic studies and greater than 100 clinical studies. Adverse effects are rare (electrotherapy stimulation may also be used as an adjunctive therapy. Copyright © 2013 Elsevier Inc. All rights reserved.

  20. Acupuncture Improves Peri-menopausal Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Fu, Cong; Zhao, Na; Liu, Zhen; Yuan, Lu-Hua; Xie, Chen; Yang, Wen-Jia; Yu, Xin-Tong; Yu, Huan; Chen, Yun-Fei

    2017-11-01

    To evaluate the short-term efficacy of acupuncture for the treatment of peri-menopausal insomnia (PMI). Design: A randomized, participant-blind, placebo-controlled trial consisted of the acupuncture group (n = 38) and placebo-acupuncture group (n = 38). Setting: A tertiary teaching and general hospital. Participants: 76 peri-menopausal women with insomnia disorder based on the International Classification of Sleep Disorders, Third Edition. Interventions: A 10-session of acupuncture at bilateral Shenshu (BL 23) and Ganshu (BL 18) with unilateral Qimen (LR 14) and Jingmen (GB 25) or Streitberger needles at the same acupoints was performed for over 3 weeks. Measurements: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with over-night polysomnography (PSG) exam were completed at baseline and post-treatment. After the treatments, the decrease from baseline in PSQI score was 8.03 points in acupuncture group and 1.29 points in placebo-acupuncture group. The change from baseline in ISI score was 11.35 points in acupuncture group and 2.87 points in placebo-acupuncture group. In PSG data, acupuncture significantly improved the sleep efficiency and total sleep time, associated with less wake after sleep onset and lower percent stage 1 after the treatment. No significant differences from baseline to post-treatment were found in placebo-acupuncture group. Acupuncture can contribute to a clinically relevant improvement in the short-term treatment of PMI, both subjectively and objectively. Acupuncture for peri-menopause insomnia: a randomized controlled trial, http://www.chictr.org.cn/showproj.aspx?proj=12118 ChiCTR-IPR-15007199, China. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  1. Suanzaoren Formulae for Insomnia: Updated Clinical Evidence and Possible Mechanisms

    Directory of Open Access Journals (Sweden)

    Qi-Hui Zhou

    2018-02-01

    Full Text Available Insomnia disorder is a widespread and refractory disease. Semen Ziziphi Spinosae, Suanzaoren, a well-known Chinese herbal medicine, has been used for treating insomnia for thousands of years. Here, we aimed to assess the available evidence of Chinese herbal formulae that contains Suanzaoren (FSZR for insomnia according to high-quality randomized controlled trials (RCTs and reviewed their possible mechanisms based on animal-based studies. Electronic searches were performed in eight databases from inception to November 2016. The primary outcome measures were polysomnography index and Pittsburgh sleep quality index. The secondary outcome measures were clinical effective rate and adverse events. The methodological quality of RCTs was assessed by Cochrane's collaboration tool, and only RCTs with positive for 4 out of 7 for the Cochrane risk of bias domains were included in analyses. Thirteen eligible studies with 1,454 patients were identified. Meta-analysis of high-quality RCTs showed that FSZR monotherapy was superior to placebo (P < 0.01; FSZR plus Diazepam was superior to Diazepam alone (P < 0.05; there were mixed results comparing FSZR with Diazepam (P > 0.05 or P < 0.05. Furthermore, FSZR caused fewer side effects than that of Diazepam. Suanzaoren contains complex mixtures of phytochemicals including sanjoinine A, Jujuboside A, spinosin and other flavonoids, which has sedative and hypnotic functions primarily mediated by the GABAergic and serotonergic system. In conclusion, the findings of present study supported that FSZR could be an alternative treatment for insomnia in clinic. FSZR exerted sedative and hypnotic actions mainly through the GABAergic and serotonergic system.

  2. Pengalaman Mahasiswa Yang Mengalami Insomnia Selama Mengerjakan Tugas Akhir

    OpenAIRE

    Rizqiea, Noerma Shovie; Hartati, Elis

    2012-01-01

    The interview that was done by the researcher to 25 informants of students gave a preliminary data, 10 of students stated that they have insomnia while doing their final project. The general purpose of this study was to identify student experiences of class 2008 PSIK FK UNDIP in doing their final project. This research was qualitative study with phenomenological approach. The method of collecting data was in-depth interview with 5 informants from student of class 2008 PSIK FK UNDIP who experi...

  3. Prevalence and consequences of insomnia in pediatric population.

    OpenAIRE

    Magda Kaczor; Michał Skalski

    2016-01-01

    Insomnia presents an increasing and significant health issue in paediatric population. As the problem had grown over past decade, it became recognised by the specialists dealing with children and adolescents. In a recent study American Academy of Child and Adolescent Psychiatry members were asked about their experience with patients complaining about sleep disturbances. Doctors reported that sleep was a problem for 1/3 of their patients out of which 1/4 required pharmacotherapy [1]. Multiple ...

  4. Does physiological hyperarousal enhance error rates among insomnia sufferers?

    Science.gov (United States)

    Edinger, Jack D; Means, Melanie K; Krystal, Andrew D

    2013-08-01

    To examine the association between physiological hyperarousal and response accuracy on reaction time tasks among individuals with insomnia. This study was conducted at affiliated Veterans Administration (VA) and academic medical centers using a matched-group, cross-sectional research design. Eighty-nine individuals (48 women) with primary insomnia, PI (MAge = 49.8 ± 17.2 y) and 95 individuals (48 women) who were well-screened normal sleepers, NS (MAge = 46.9 ± 17.0 y). Participants underwent 3 nights of polysomnography followed by daytime testing with a four-trial Multiple Sleep Latency Test (MSLT). Before each MSLT nap, they rated their sleepiness and completed computer-administered reaction time tasks. The mean number of correct and error responses made by each participant across testing trials served as dependent measures. The PI and NS groups were each subdivided into alert (e.g., MSLT mean onset latency > 8 min) and sleepy (e.g., MSLT mean onset latency ≤ 8 min) subgroups to allow for testing the main and interaction effects of participant type and level of alertness. Alert participants had longer MSLT latencies than sleepy participants (12.7 versus 5.4 min), yet both alert and sleepy individuals with PI reported greater sleepiness than NS. Alert participants also showed lower sleep efficiencies (83.5% versus 86.2%, P = 0.03), suggesting 24-h physiological hyperarousal particularly in the PI group. Individuals with PI had fewer correct responses on performance testing than did NS, whereas a significant group × alertness interaction (P = 0.0013) showed greater error rates among alert individuals with PI (mean = 4.5 ± 3.6 errors per trial) than among alert NS (mean = 2.6 ± 1.9 errors per trial). Physiological hyperarousal in insomnia may lead to more apparent daytime alertness yet dispose individuals with insomnia to higher error rates on tasks requiring their attention.

  5. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial.

    Science.gov (United States)

    Edinger, Jack D; Wohlgemuth, William K; Krystal, Andrew D; Rice, John R

    2005-11-28

    Insomnia is common and debilitating to fibromyalgia (FM) patients. Cognitive-behavioral therapy (CBT) is effective for many types of patients with insomnia, but has yet to be tested with FM patients. This study compared CBT with an alternate behavioral therapy and usual care for improving sleep and other FM symptoms. This randomized clinical trial enrolled 47 FM patients with chronic insomnia complaints. The study compared CBT, sleep hygiene (SH) instructions, and usual FM care alone. Outcome measures were subjective (sleep logs) and objective (actigraphy) total sleep time, sleep efficiency, total wake time, sleep latency, wake time after sleep onset, and questionnaire measures of global insomnia symptoms, pain, mood, and quality of life. Forty-two patients completed baseline and continued into treatment. Sleep logs showed CBT-treated patients achieved nearly a 50% reduction in their nocturnal wake time by study completion, whereas SH therapy- and usual care-treated patients achieved only 20% and 3.5% reductions on this measure, respectively. In addition, 8 (57%) of 14 CBT recipients met strict subjective sleep improvement criteria by the end of treatment compared with 2 (17%) of 12 SH therapy recipients and 0% of the usual care group. Comparable findings were noted for similar actigraphic improvement criteria. The SH therapy patients showed favorable outcomes on measures of pain and mental well-being. This finding was most notable in an SH therapy subgroup that self-elected to implement selected CBT strategies. Cognitive-behavioral therapy represents a promising intervention for sleep disturbance in FM patients. Larger clinical trials of this intervention with FM patients seem warranted.

  6. POLARIZED LIGHT APPLICATION AT CHRONIC INSOMNIA AND HABIT OF SMOKING

    OpenAIRE

    D. Tubič; M. Skorbič

    2016-01-01

    In the treatment of patients with situational neurosis, which for years suffered from insomnia, we used a BIOPTRON-2 device. After 10 everyday evening sessions, the process of falling asleep was normalized, and night sleep was maintained with no additional drugs. A group of 30 patients with a chronic habit of intensive smoking was subjected to applications of BIOPTRON-2 generated PILER light for 10 days. In a considerable part of the tested persons, we noticed a decrease in the inclination fo...

  7. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial.

    Science.gov (United States)

    Blom, Kerstin; Jernelöv, Susanna; Kraepelien, Martin; Bergdahl, Malin Olséni; Jungmarker, Kristina; Ankartjärn, Linda; Lindefors, Nils; Kaldo, Viktor

    2015-02-01

    To compare treatment effects when patients with insomnia and depression receive treatment for either insomnia or depression. A 9-w randomized controlled trial with 6- and 12-mo follow-up. Internet Psychiatry Clinic, Stockholm, Sweden. Forty-three adults in whom comorbid insomnia and depression were diagnosed, recruited via media and assessed by psychiatrists. Guided Internet-delivered cognitive behavior therapy (ICBT) for either insomnia or depression. Primary outcome measures were symptom self-rating scales (Insomnia Severity Index [ISI] and the Montgomery Åsberg Depression Rating Scale [MADRS-S]), assessed before and after treatment with follow-up after 6 and 12 mo. The participants' use of sleep medication and need for further treatment after completion of ICBT was also investigated. The insomnia treatment was more effective than the depression treatment in reducing insomnia severity during treatment (P = 0.05), and equally effective in reducing depression severity. Group differences in insomnia severity were maintained during the 12-mo follow-up period. Post treatment, participants receiving treatment for insomnia had significantly less self-rated need for further insomnia treatment (P treatment for depression. The need for depression treatment was similar in both groups. In this study, Internet-delivered treatment with cognitive behavior therapy (ICBT) for insomnia was more effective than ICBT for depression for patients with both diagnoses. This indicates, in line with previous research, that insomnia when comorbid with depression is not merely a symptom of depression, but needs specific treatment. The trial was registered at Clinicaltrials.gov, registration ID: NCT01256099. © 2015 Associated Professional Sleep Societies, LLC.

  8. Is insomnia associated with deficits in neuropsychological functioning? Evidence from a population-based study.

    Science.gov (United States)

    Goldman-Mellor, Sidra; Caspi, Avshalom; Gregory, Alice M; Harrington, HonaLee; Poulton, Richie; Moffitt, Terrie E

    2015-04-01

    People with insomnia complain of cognitive deficits in daily life. Results from empirical studies examining associations between insomnia and cognitive impairment, however, are mixed. Research is needed that compares treatment-seeking and community-based insomnia study samples, measures subjective as well as objective cognitive functioning, and considers participants' pre-insomnia cognitive function. We used data from the Dunedin Study, a representative birth cohort of 1,037 individuals, to examine whether insomnia in early midlife was associated with subjective and objective cognitive functioning. We also tested whether individuals with insomnia who reported seeking treatment for their sleep problems (treatment-seekers) showed greater impairment than other individuals with insomnia (non-treatment-seekers). The role of key confounders, including childhood cognitive ability and comorbid health conditions, was evaluated. Insomnia was diagnosed at age 38 according to DSM-IV criteria. Objective neuropsychological assessments at age 38 included the WAIS-IV IQ test, the Wechsler Memory Scale, and the Trail-Making Test. Childhood cognitive functioning was assessed using the Wechsler Intelligence Scale for Children-Revised (WISC-R). A total of 949 cohort members were assessed for insomnia symptoms and other study measures at age 38. Although cohort members with insomnia (n = 186, 19.6%) had greater subjective cognitive impairment than their peers at age 38, they did not exhibit greater objective impairment on formal testing. Treatment-seekers, however, exhibited significant objective impairment compared to non-treatment-seekers. Controlling for comorbidity, daytime impairment, and medications slightly decreased this association. Childhood cognitive deficits antedated the adult cognitive deficits of treatment-seekers. Links between insomnia and cognitive impairment may be strongest among individuals who seek clinical treatment. Clinicians should take into account the

  9. Global sleep dissatisfaction for the assessment of insomnia severity in the general population of Portugal.

    Science.gov (United States)

    Ohayon, Maurice M; Paiva, Teresa

    2005-09-01

    This study examines the prevalence and associated factors of insomnia symptoms and sleep dissatisfaction in the general population of Portugal. We interviewed by telephone 1858 participants aged 18 years or older and representative of the general population of Portugal using the Sleep-EVAL system. Participation rate was 83%. The questionnaire included the assessment of sleep habits, insomnia symptomatology according to DSM-IV and ICSD classifications, associated and sleep/mental disorders and daytime consequences. Insomnia symptoms occurring at least 3 nights per week were reported by 28.1% of the sample and global sleep dissatisfaction (GSD) by 10.1%. Difficulty maintaining sleep was the most frequent symptom (21.0%); 29.4% of subjects with insomnia symptoms reported GSD. Daytime consequences, medical consultations for sleep and use of sleep medication were at least 2 times more frequent among subjects with insomnia symptoms and GSD compared to subjects with insomnia symptoms without GSD; insomnia diagnoses were also more frequent in the GSD group. The results show a severity gradation among subjects with only 1 insomnia symptom, those with 2 or 3 insomnia symptoms but without GSD and those with at least 1 insomnia symptom and GSD. Specific sleep or psychiatric disorders were identified for the majority of GSD subjects (86%); this rate dropped to 50.6% when only 1 insomnia symptom without GSD was reported. GSD appeared to be a good indicator of the presence of a sleep or psychiatric disorder and a good discriminator of the severity of sleep disturbances among subjects with insomnia symptoms.

  10. Intensive Sleep Deprivation and Cognitive Behavioral Therapy for Pharmacotherapy Refractory Insomnia in a Hospitalized Patient

    OpenAIRE

    Breitstein, Joshua; Penix, Brandon; Roth, Bernard J.; Baxter, Tristin; Mysliwiec, Vincent

    2014-01-01

    The case of a 59-year-old woman psychiatrically hospitalized with comorbid insomnia, suicidal ideation, and generalized anxiety disorder is presented. Pharmacologic therapies were unsuccessful for treating insomnia prior to and during hospitalization. Intensive sleep deprivation was initiated for 40 consecutive hours followed by a recovery sleep period of 8 hours. Traditional components of cognitive behavioral therapy for insomnia (CBTi), sleep restriction, and stimulus control therapies, wer...

  11. The efficacy of pregabalin and benzodiazepines in generalized anxiety disorder presenting with high levels of insomnia.

    Science.gov (United States)

    Montgomery, Stuart A; Herman, Barry K; Schweizer, Edward; Mandel, Francine S

    2009-07-01

    The objective of this study was to assess the impact of high levels of insomnia on response to pregabalin (PGB) in patients with generalized anxiety disorder (GAD). Pooled data were analyzed from six double-blind, placebo-controlled, 4- to 6-week trials of outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) criteria for GAD with a minimum Hamilton Rating Scale for Anxiety (HAM-A) score = 18. Response was evaluated for three fixed-dose PGB groups (150, 300-450, 600 mg/day), and for a benzodiazepine group (alprazolam or lorazepam). A 'high-insomnia' subgroup was defined by a baseline HAM for Depression (HAM-D) insomnia factor score greater than 3 (maximum = 6). At baseline, 1002 (54%) patients met the criteria for the high-insomnia subgroup, and 852 (46%) for the low-insomnia subgroup. Mean baseline HAM-A scores were 1-2 points higher in high-insomnia versus low-insomnia patients. In high-insomnia patients, PGB produced significantly greater improvement in HAM-A total scores at last observation carried forward endpoint on 300-450 mg (-13.1+/-0.6) and 600 mg (-11.2+/-0.5) dose groups compared with placebo (-8.3+/-0.5; Pinsomnia subgroup, treatment with PGB significantly (Pinsomnia factor scores on both the 300-450 mg (-2.73) and 600 mg (-2.35) doses, and on benzodiazepines (-2.52) compared with placebo (-1.51); improvement on PGB 150 mg (-1.69) was not significant. Rates of treatment-emergent insomnia were lower on PGB compared with placebo in both the high- and low-insomnia subgroups. In conclusion, PGB was well tolerated, and improved overall anxiety symptoms, while specifically improving insomnia in patients with GAD presenting with high levels of concurrent insomnia.

  12. The predictive power of personality traits on insomnia symptoms: a longitudinal study among shift workers

    OpenAIRE

    Larsgård, Borgar

    2015-01-01

    Shift work can have adverse effects on employees' health, including symptoms of insomnia. This may cause severe problems both for employee and employer. The personality variables morningness, neuroticism and extraversion, along with some demographic variables (e.g. gender, age) have been found to correlate with insomnia symptoms, but predictive data have been scarce. This study sought to discover whether personality variables could predict insomnia. A hierarchical longitudinal (six months)...

  13. Faktor-Faktor Yang Mempengaruhi Kejadian Insomnia di Poliklinik Saraf RS DR. M. Djamil Padang

    OpenAIRE

    Lydia Susanti

    2015-01-01

    Abstrak Faktor risiko seperti usia lanjut, jenis kelamin wanita, penyakit penyerta (depresi dan penyakit lain), status sosial ekonomi rendah menyebabkan insomnia. Penelitian mengenai prevalensi dan faktor-faktor yang mempengaruhi kejadian insomnia di Poliklinik Saraf RS DR. M. Djamil Padang belum pernah dilakukan. Tujuan penelitian ini adalah menentukan faktor-faktor yang mempengaruhi terjadinya insomnia di poliklinik saraf RS DR. M. Djamil Padang. Penelitian ini merupakan penelitian cross se...

  14. Evaluation of Trazodone and Quetiapine for Insomnia: An Observational Study in Psychiatric Inpatients

    OpenAIRE

    Doroudgar, Shadi; Chou, Tony I-Fan; Yu, Junhua; Trinh, Karen; Pal, Jai; Perry, Paul J.

    2013-01-01

    Background: Insomnia is symptomatic of most psychiatric disorders. Non–habit-forming agents such as trazodone and quetiapine are commonly used off-label to treat patients with insomnia. The safety and efficacy of trazodone and quetiapine as medications for treatment of insomnia have never been directly contrasted. The objective of this study was to compare the effectiveness of trazodone to quetiapine among inpatient psychiatric patients by measuring the traditional sleep parameters of total s...

  15. Hypnosis for treatment of insomnia in school-age children: a retrospective chart review

    OpenAIRE

    Slothower Molly P; Anbar Ran D

    2006-01-01

    Abstract Background The purposes of this study are to document psychosocial stressors and medical conditions associated with development of insomnia in school-age children and to report use of hypnosis for this condition. Methods A retrospective chart review was performed for 84 children and adolescents with insomnia, excluding those with central or obstructive sleep apnea. All patients were offered and accepted instruction in self-hypnosis for treatment of insomnia, and for other symptoms if...

  16. Prevalensi Kejadian Insomnia pada Mahasiswa Fakultas Kedokteran Univesitas Sematera Utara Tahun 2015

    OpenAIRE

    Pamungkas, Anugrah Octa

    2016-01-01

    Insomnia is defined as difficulty to initiate sleep complaints. Difficulty maintaining sleep or experiencing non-restorative sleep, and usually associated with problems in the daytime activity. Insomnia is a sleep disorder that is most commonly found and experienced by many college students. The purpose of this study was to determine the prevalence of insomnia in medical student at University of North Sumatra in 2015, used a descriptive study with cross sectional approach. This research using...

  17. Sleep Related Cognitions in Individuals with Symptoms of Insomnia and Depression.

    Science.gov (United States)

    Levenson, Jessica C; Benca, Ruth M; Rumble, Meredith E

    2015-08-15

    Depression has been identified as the most common condition comorbid to insomnia, with findings pointing to the possibility that these disorders may be causally related to each other or may share common mechanisms. Some have suggested that comorbid insomnia and depression may have a different clinical course than either condition alone, and may thus require specific treatment procedures. In this report we examined the clinical characteristics of individuals referred to an academic sleep center who report comorbid symptoms of insomnia and depression and those with symptoms of insomnia outside the context of meaningful depression, and we identified differences between these groups with regard to several cognitive-related variables. Logistic regression analyses examined whether past week worry, dysfunctional beliefs about sleep, and insomnia symptom-focused rumination predicted group membership. Individuals with comorbid symptoms of insomnia and depression reported more past-week worry, dysfunctional beliefs about sleep, and insomnia symptom-focused rumination, than those with symptoms of insomnia without significant depression symptoms. When including all three cognitive-related variables in our model, those with comorbid symptoms reported more severe insomnia symptom-focused rumination, even when controlling for insomnia and mental health severity, among other relevant covariates. The findings contribute to our understanding of the complex nature of comorbid symptoms of insomnia and depression and the specific symptom burden experienced by those with significant depression symptoms in the presence of insomnia. The findings also highlight the need for increased clinical attention to the sleep-focused rumination reported by these patients. © 2015 American Academy of Sleep Medicine.

  18. Insomnia and hypnotic use in Campo Grande general population, Brazil

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    Souza José Carlos

    2002-01-01

    Full Text Available The insomnia prevalence in general population was determined by means of 408 home interviews of adults, in a representative sample of Campo Grande city, Brazil. The random sample was stratified by sex, age and economic social status. Insomnia subtypes evaluated were the disorders of sleep initiation (DSI, sleep maintenance (DSM and early awakening (DEA. A structured questionnaire was used with the consent from the interviewed subjects. Statistics used chi-square, and Fisher tests; and inferences based on binomial distribution parameters; the significance level was 5% and confidence interval (CI was 95%.The general prevalence of insomnia was 19.1% (sd=2.0%, mostly women (p=0.0015, and people of less years of schooling (p=0.0317, subtype DSI (14.2%, p=0.0043, and chronic (p=0.7022. Hypnotic drugs were used by 6.9%(sd=1.3% in the last month. Use in the last 2 years, 70.3% mostly insomniacs (p<0.0001, women (p=0.0372 and people over 30 years of age (p=0.0536.

  19. EEG Power During Waking and NREM Sleep in Primary Insomnia

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    Wu, You Meme; Pietrone, Regina; Cashmere, J. David; Begley, Amy; Miewald, Jean M.; Germain, Anne; Buysse, Daniel J.

    2013-01-01

    Objective: Pathophysiological models of insomnia invoke the concept of 24-hour hyperarousal, which could lead to symptoms and physiological findings during waking and sleep. We hypothesized that this arousal could be seen in the waking electroencephalogram (EEG) of individuals with primary insomnia (PI), and that waking EEG power would correlate with non-REM (NREM) EEG. Methods: Subjects included 50 PI and 32 good sleeper controls (GSC). Five minutes of eyes closed waking EEG were collected at subjects' usual bedtimes, followed by polysomnography (PSG) at habitual sleep times. An automated algorithm and visual editing were used to remove artifacts from waking and sleep EEGs, followed by power spectral analysis to estimate power from 0.5–32 Hz. Results: We did not find significant differences in waking or NREM EEG spectral power of PI and GSC. Significant correlations between waking and NREM sleep power were observed across all frequency bands in the PI group and in most frequency bands in the GSC group. Conclusions: The absence of significant differences between groups in waking or NREM EEG power suggests that our sample was not characterized by a high degree of cortical arousal. The consistent correlations between waking and NREM EEG power suggest that, in samples with elevated NREM EEG beta activity, waking EEG power may show a similar pattern. Citation: Wu YM; Pietrone R; Cashmere JD; Begley A; Miewald JM; Germain A; Buysse DJ. EEG power during waking and NREM sleep in primary insomnia. J Clin Sleep Med 2013;9(10):1031-1037. PMID:24127147

  20. Pharmacotherapy Treatment Options for Insomnia: A Primer for Clinicians

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    Gregory M. Asnis

    2015-12-01

    Full Text Available Insomnia is a prevalent disorder with deleterious effects such as decreased quality of life, and a predisposition to a number of psychiatric disorders. Fortunately, numerous approved hypnotic treatments are available. This report reviews the state of the art of pharmacotherapy with a reference to cognitive behavioral therapy for insomnia (CBT-I as well. It provides the clinician with a guide to all the Food and Drug Administration (FDA approved hypnotics (benzodiazepines, nonbenzodiazepines, ramelteon, low dose sinequan, and suvorexant including potential side effects. Frequently, chronic insomnia lasts longer than 2 years. Cognizant of this and as a result of longer-term studies, the FDA has approved all hypnotics since 2005 without restricting the duration of use. Our manuscript also reviews off-label hypnotics (sedating antidepressants, atypical antipsychotics, anticonvulsants and antihistamines which in reality, are more often prescribed than approved hypnotics. The choice of which hypnotic to choose is discussed partially being based on which segment of sleep is disturbed and whether co-morbid illnesses exist. Lastly, we discuss recent label changes required by the FDA inserting a warning about “sleep-related complex behaviors”, e.g., sleep-driving for all hypnotics. In addition, we discuss FDA mandated dose reductions for most zolpidem preparations in women due to high zolpidem levels in the morning hours potentially causing daytime carry-over effects.

  1. Non-pharmachological approaches to the treatment of chronic insomnia

    Directory of Open Access Journals (Sweden)

    Vita Štukovnik

    2013-05-01

    Full Text Available Sleep disorders have a negative impact on the quality of life and contribute to physical and mental health problems. Insomnia is a pervasive condition with various causes, manifestations, and health consequences. Even though it can be triggered by a variety of precipitating events, psychological and behavioral factors are almost always involved in perpetuating or exacerbating it over time, and lead to chronic condition. This article reviews some basic models and mechanisms of chronic insomnia as well as the rationale and objectives of cognitive-behavioral therapy (CBT in its management. CBT is a safe and effective treatment that may be used either as a monotherapy or to augment therapy with drugs. Evidence from controlled clinical trials indicates that the majority of patients (70 % to 80 % with persistent insomnia respond to this treatment, which is comparable to medication treatment. Aside from the clinically measurable changes, this therapy system enables patients to regain a feeling of control over their sleep, thereby reducing the emotional distress that sleep disorders cause. But despite the evidence for effectiveness and efficacy of these therapies and also the preference for non-pharmacological treatments expressed by many patients, psychological and behavioral approaches still remain underutilized by health care practitioners. Thus, an important challenge for the future is to disseminate these evidence-based therapies more effectively and increase their routine use in clinical practice.

  2. Sleep disorders: insomnia, sleepwalking, night terrors, nightmares, and enuresis.

    Science.gov (United States)

    Kales, A; Soldatos, C R; Kales, J D

    1987-04-01

    All five sleep disorders reviewed in this article can be adequately evaluated in the physician's office by taking a sleep history and conducting a careful general medical and psychiatric assessment. Insomnia, the commonest sleep disorder, is more prevalent among women and elderly and psychosocially disadvantaged persons. Personality factors such as a tendency toward the internalization of emotions and the occurrence of stressful life events also play a major role in the development of chronic insomnia. A multidimensional approach is indicated for the treatment of chronic insomnia; hypnotic drugs should be used only as an adjunct to this treatment. In children, sleepwalking and night terrors (two manifestations of the same pathophysiologic substrate), nightmares, and enuresis are commonly related to developmental factors; counseling and reassurance of the parents is indicated. Psychopathologic disorders are usually present in secondary enuresis, as well as in sleepwalking, night terrors, and nightmares that occur in adulthood. Psychotherapy and the occasional use of psychotropic drugs may be necessary in the treatment given adults with these disorders.

  3. Post-marketing surveillance: adverse events during long-term use of atovaquone/proguanil for travelers to malaria-endemic countries.

    Science.gov (United States)

    Overbosch, David

    2003-05-01

    Atovaquone/proguanil in Europe is only licensed for 4 weeks of travel. Data on its long-term tolerability in nonimmune travelers are scarce. We prospectively studied adverse reactions reported by long-term travelers using atovaquone/proguanil among a population intolerant to mefloquine. The average length of atovaquone/proguanil use was 9 weeks (4.5 to 34 weeks). Adverse events were recorded on a regular questionnaire. Travelers rated complaints as: (1) mild, not interfering with their daily activities; (2) moderate, causing interference, such as canceling a trip or being confined to the hotel; or (3) severe, causing a visit to a doctor or clinic. Hospital admission was classified as category 3 and specified. We then compared our data with those on adverse reactions from 2 large multicenter studies of atovaquone/proguanil in nonimmune travelers. One hundred and fifty-four subjects used atovaquone/proguanil for a total of 1538 weeks. Diarrhea was the most common ailment (18%). Further complaints were abdominal pain (mild 4%, moderate 5%, severe 2%), headache (mild 4%, moderate 4%, severe 1%), dizziness (mild 3%, moderate 1%, severe 1%), and insomnia (mild 6%, moderate 0%, severe 0%). Two subjects of 154 (1%) discontinued prophylaxis, both due to diarrhea. Nobody was admitted to hospital. No case of malaria was reported. Comparison with data from previous, larger atovaquone/proguanil studies shows that the adverse events reported by the long-term atovaquone/proguanil users are no different in type and frequency of occurrence to those travel-related health problems normally encountered in the Tropics. Atovaquone/proguanil was well tolerated by these long-term travelers. Long-term users of atovaquone/ proguanil antimalarial prophylaxis suffer no more ailments than normally occur to travelers in tropical regions.

  4. Prevalence, severity and risk factors for depressive symptoms and insomnia in college undergraduates.

    Science.gov (United States)

    Gress-Smith, Jenna L; Roubinov, Danielle S; Andreotti, Charissa; Compas, Bruce E; Luecken, Linda J

    2015-02-01

    Although the college years represent a high-risk period for depressive symptoms and insomnia, little research has explored their prevalence, comorbidities and risk factors within this developmental period. Two studies were conducted; the first evaluated the prevalence and comorbidity of depressive symptoms and insomnia in 1338 students (ages 18-23 years) from a large Southwestern University. Mild depressive symptoms were endorsed by 19% of students and 14.5% reported moderate to severe symptoms. Forty-seven percent of students reported mild insomnia and 22.5% endorsed moderate to severe insomnia severity. A second study investigated perceived stress as a potential mediator of the relation between self-reported childhood adversity and concurrent depressive symptoms and insomnia. Undergraduates (N = 447) from a Southwestern and Southeastern University reported prior childhood adversity, current perceived stress, insomnia and depressive symptoms. Self-reported childhood adversity predicted higher levels of depressive symptoms and insomnia severity, partially mediated by perceived stress. Results support the high prevalence of depressive symptoms and insomnia among undergraduates. The risk for depressive and insomnia symptoms may be increased among students who experienced greater levels of childhood adversity. © 2013 John Wiley & Sons, Ltd.

  5. How do I best manage insomnia and other sleep disorders in older adults with cancer?

    Science.gov (United States)

    Loh, Kah Poh; Burhenn, Peggy; Hurria, Arti; Zachariah, Finly; Mohile, Supriya Gupta

    2016-11-01

    Insomnia is common in older adults with cancer, with a reported prevalence of 19-60% in prior studies. Cancer treatments are associated with increased risk of insomnia or aggravation of pre-existing insomnia symptoms, and patients who are receiving active cancer treatments are more likely to report insomnia. Insomnia can lead to significant physical and psychological consequences with increased mortality. We discuss physiological sleep changes in older adults, and illustrated the various sleep disorders. We present a literature review on the prevalence and the effects of insomnia on the quality of life in older adults with cancer. We discuss the risk factors and presented a theoretical framework of insomnia in older adults with cancer. We present a case study to illustrate the assessment and management of insomnia in older adults with cancer, comparing and contrasting a number of tools for sleep assessment. There are currently no guidelines on the treatment of sleep disorders in older adults with cancer. We present an algorithm developed at the City of Hope Comprehensive Cancer Center by a multidisciplinary team for managing insomnia, using evidence-based pharmacologic and non-pharmacologic interventions. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. INSOMNIA DAN DIAGNOSIS PSIKIATRI PADA PASIEN DI INSTALASI RAWAT DARURAT (IRD RSUP SANGLAH

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    Alfa Matrika Sapta Dewanti

    2015-01-01

    Full Text Available Insomnia adalah suatu kesulitan dalam memulai tidur, mempertahankan tidur, atau tiduryang tidak menyegarkan selama 1 bulan atau lebih di mana keadaan sulit tidur ini harusmenyebabkan gangguan klinis yang signifikan. Insomnia dibagi menjadi insomnia primerdan sekunder. Penelitian ini merupakan penelitian deskriptif yang bertujuan untukmenjelaskan karakteristik insomnia dan diagnosis psikiatri pada pasien di Instalasi RawatDarurat (IRD RSUP Sanglah. Data penelitian ini berdasarkan register pasien IRD RSUPSanglah periode Mei-November 2013. Sampel yang memenuhi kriteria inklusi ini terdiridari 52 laki-laki (49% dan 54 perempuan (51%. Menurut tipe insomnia, 17% insomniaprimer dan 83% insomnia sekunder. Berdasarkan usia, 11% pada usia  ?20 tahun, 32%pada usia 21-30 tahun, usia 31-50 tahun  40% dan 17% pada usia>50 tahun. Pasien yangmenikah 51%, belum menikah 39%, janda 6% dan duda 4%. Pasien yang bekerja 56% dan44% tidak bekerja. Berdasarkan diagnosis psikiatri, skizofrenia 20 (22,7%, psikotik akut17 (19,3%, depresi  12 (13,6%, bipolar 7 (8%, delirium 8 (9,1%, GMO 10 (11,4% dangangguan penyesuaian 14 (15,9%. Dari keseluruhan pasien insomnia yang datang ke IRD,17% merupakan insomnia primer dan 83% insomnia sekunder. Diagnosis psikiatri pasieninsomnia terbanyak adalah pasien psikotik, yaitu skizofrenia 22,7% dan psikotik akut19,3%.

  7. New developments in cognitive behavioral therapy as the first-line treatment of insomnia

    Directory of Open Access Journals (Sweden)

    Allison T Siebern

    2011-02-01

    Full Text Available Allison T Siebern, Rachel ManberSleep Medicine Center, Stanford University School of Medicine, Redwood City, California, USAAbstract: Insomnia is the most common sleep disorder. Psychological, behavioral, and biological factors are implicated in the development and maintenance of insomnia as a disorder, although the etiology of insomnia remains under investigation, as it is still not fully understood. Cognitive behavioral therapy for insomnia (CBTI is a treatment for insomnia that is grounded in the science of behavior change, psychological theories, and the science of sleep. There is strong empirical evidence that CBTI is effective. Recognition of CBTI as the first-line treatment for chronic insomnia (National Institutes of Health consensus, British Medical Association was based largely on evidence of its efficacy in primary insomnia. The aim of this article is to provide background information and review recent developments in CBTI, focusing on three domains: promising data on the use of CBTI when insomnia is experienced in the presence of comorbid conditions, new data on the use of CBTI as maintenance therapy, and emerging data on the delivery of CBTI through the use of technology and in primary care settings.Keywords: insomnia, CBTI, nonpharmacological treatment

  8. Insomnia in a displaced population is related to war-associated remembered stress.

    Science.gov (United States)

    Basishvili, Tamar; Eliozishvili, Marine; Maisuradze, Lia; Lortkipanidze, Nani; Nachkebia, Nargiz; Oniani, Tengiz; Gvilia, Irma; Darchia, Nato

    2012-08-01

    Although traumatic events are presumed to cause sleep disturbances, particularly insomnia, sleep in populations subjected to forced displacement has received little attention. The present study examined the prevalence of insomnia and associated factors in internally displaced persons (IDPs) from Abkhazia 15 years after displacement to Tbilisi. Detailed subjective information about sleep-wake habits, sleep-related and stress-related parameters were obtained from 87 IDPs categorized into good sleepers and insomniacs. The Insomnia Severity Index, Perceived Stress Scale and Beck Depression Inventory were administered. The incidence of insomnia was 41.4%. The majority of insomniacs strongly believed that war-related stress accounted for the onset of their insomnia. Stepwise regression (95% confidence interval) revealed four variables significantly associated with insomnia status: self-estimated influence of war related stress (odds ratio (OR) = 2.51), frequency of nightmares (OR = 1.6), Perceived Stress Scale score (OR = 1.14) and Beck Depression Inventory score (OR = 1.12). Insomnia in IDPs was strongly related to war-associated remembered stress. ‛Over thinking' about major stress exposure enhanced IDPs' vulnerability to insomnia. These findings have implications for the management of insomnia and associated impairment of daytime functioning in IDPs. Copyright © 2011 John Wiley & Sons, Ltd.

  9. Insomnia with short sleep duration and mortality: the Penn State cohort.

    Science.gov (United States)

    Vgontzas, Alexandros N; Liao, Duanping; Pejovic, Slobodanka; Calhoun, Susan; Karataraki, Maria; Basta, Maria; Fernández-Mendoza, Julio; Bixler, Edward O

    2010-09-01

    Because insomnia with objective short sleep duration is associated with increased morbidity, we examined the effects of this insomnia subtype on all-cause mortality. Longitudinal. Sleep laboratory. 1,741 men and women randomly selected from Central Pennsylvania. Participants were studied in the sleep laboratory and were followed-up for 14 years (men) and 10 years (women). "Insomnia" was defined by a complaint of insomnia with duration > or = 1 year. "Normal sleeping" was defined as absence of insomnia. Polysomnographic sleep duration was classified into two categories: the "normal sleep duration group" subjects who slept > or = 6 h and the "short sleep duration group" subjects who slept insomnia" group, (OR = 4.00, CI 1.14-13.99) after adjusting for diabetes, hypertension, and other confounders. Furthermore, there was a marginally significant trend (P = 0.15) towards higher mortality risk from insomnia and short sleep in patients with diabetes or hypertension (OR = 7.17, 95% CI 1.41-36.62) than in those without these comorbid conditions (OR = 1.45, 95% CI 0.13-16.14). In women, mortality was not associated with insomnia and short sleep duration. Insomnia with objective short sleep duration in men is associated with increased mortality, a risk that has been underestimated.

  10. Behavioral Profiles Associated with Objective Sleep Duration in Young Children with Insomnia Symptoms.

    Science.gov (United States)

    Calhoun, Susan L; Fernandez-Mendoza, Julio; Vgontzas, Alexandros N; Mayes, Susan D; Liao, Duanping; Bixler, Edward O

    2017-02-01

    Based on previous studies reporting on the association of objective sleep duration and physiologic changes (i.e., increased cortisol) in children, we examined the role of objective sleep duration on differentiating behavioral profiles in children with insomnia symptoms. Seven hundred children (ages 5-12, 47.8% male) from the Penn State Child Cohort underwent a nine-hour polysomnography and parent completed Pediatric Behavior Scale. Insomnia symptoms were defined as parent report of difficulty falling and/or staying asleep, sleep disordered breathing as an AHI of ≥1, and objective short sleep duration as a total sleep time insomnia symptoms demonstrated more overall behavioral problems than controls. Significant interactions between insomnia symptoms and objective sleep duration on scores of externalizing behaviors, mood variability and school problems were found. Profile analyses showed that children with insomnia symptoms and normal sleep duration were associated with clinically elevated externalizing behaviors, inattention, mood variability, and school problems, while children with insomnia and short sleep duration were associated with an overall elevated profile in which internalizing behaviors were more prominent. Childhood insomnia symptoms are associated with a wide array of behavioral problems, for which objective sleep duration is useful in differentiating behavioral profiles. Children with insomnia symptoms and normal sleep duration had a behavioral profile consistent with limit-setting and rule-breaking behaviors, while children with insomnia symptoms and short sleep duration had a behavioral profile more consistent with internalizing behaviors resembling that of psychophysiological disorders.

  11. Heritability of insomnia symptoms in youth and their relationship to depression and anxiety.

    Science.gov (United States)

    Gehrman, Philip R; Meltzer, Lisa J; Moore, Melisa; Pack, Allan I; Perlis, Michael L; Eaves, Lindon J; Silberg, Judy L

    2011-12-01

    Insomnia is a highly prevalent sleep disorder yet little is known about the role of genetic factors in its pathophysiology. The aim of this study was to examine the relative contributions of genetic and environmental factors in explaining variability in insomnia symptoms. Traditional twin design. Academic medical center. 1412 twin pairs aged 8-16 years (48.8% MZ, 47.2% DZ, 4.0% indeterminate). None. Ratings of insomnia symptoms, depression, and overanxious disorder were made by trained interviewers based on DSM-III-R criteria. ACE models were conducted using Mx statistical software. Insomnia symptoms were prevalent in this sample based both on parental (6.6%) and youth (19.5%) reports. The overall heritability of insomnia symptoms was modest (30.7%), with the remaining variance attributed to unique environmental effects. There was no evidence of sex differences in the prevalence of insomnia symptoms or in the contribution of genetic and environmental effects. In multivariate models, there was support for insomnia-specific unique environmental effects over and above overlapping effects with depression and overanxious disorder, but no evidence for insomnia-specific genetic effects. Genetic factors play a modest role in the etiology of insomnia symptoms in 8-16 year-olds. These effects overlap with the genetics of depression and overanxious disorder. Further work is needed to determine which genes confer risk for all three disorders.

  12. The relationship between mood disorder and insomnia depends on race in US veterans with epilepsy.

    Science.gov (United States)

    Ebong, Ima M; Lopez, Maria R; Kanner, Andres M; Wallace, Douglas M

    2017-05-01

    Few data exist on race, medical/psychiatric comorbidities, and insomnia symptoms in US veterans with epilepsy. Our aims were to examine 1) whether insomnia symptom prevalence was different between Black and White veterans and 2) whether predictors of insomnia symptoms varied by race. This retrospective, cross-sectional study included veterans evaluated in an epilepsy clinic over the course of 1.5years. Individuals completed standardized assessments for epilepsy and sleep complaints. Insomnia criteria were met by 1) report of difficulty with sleep initiation, maintenance, or premature awakenings accompanied by daytime impairment or 2) sedative-hypnotic use on most days of the month. Demographics, medical/psychiatric comorbidities, and medications were determined per electronic medical record review. Hierarchical multivariable logistic regression analyses were performed to determine if race, medical/mental health comorbidities, and the potential interaction of race with each comorbid condition were associated with insomnia. Our sample consisted of 165 veterans (32% Black). The unadjusted prevalence of insomnia was not different between Black and White veterans (42% vs 39%, p=0.68). In adjusted analyses, the association between mood disorder and insomnia varied by race. Depressed White veterans had over 11-times higher predicted odds of insomnia (OR 11.4, pepilepsy. Future studies are needed to explore mental health symptoms and psychosocial determinants of insomnia with larger samples of minority individuals with epilepsy. Published by Elsevier Inc.

  13. Wake High-Density Electroencephalographic Spatiospectral Signatures of Insomnia

    Science.gov (United States)

    Colombo, Michele A.; Ramautar, Jennifer R.; Wei, Yishul; Gomez-Herrero, Germán; Stoffers, Diederick; Wassing, Rick; Benjamins, Jeroen S.; Tagliazucchi, Enzo; van der Werf, Ysbrand D.; Cajochen, Christian; Van Someren, Eus J.W.

    2016-01-01

    Study Objectives: Although daytime complaints are a defining characteristic of insomnia, most EEG studies evaluated sleep only. We used high-density electroencephalography to investigate wake resting state oscillations characteristic of insomnia disorder (ID) at a fine-grained spatiospectral resolution. Methods: A case-control assessment during eyes open (EO) and eyes closed (EC) was performed in a laboratory for human physiology. Participants (n = 94, 74 female, 21–70 y) were recruited through www.sleepregistry.nl: 51 with ID, according to DSM-5 and 43 matched controls. Exclusion criteria were any somatic, neurological or psychiatric condition. Group differences in the spectral power topographies across multiple frequencies (1.5 to 40 Hz) were evaluated using permutation-based inference with Threshold-Free Cluster-Enhancement, to correct for multiple comparisons. Results: As compared to controls, participants with ID showed less power in a narrow upper alpha band (11–12.7 Hz, peak: 11.7 Hz) over bilateral frontal and left temporal regions during EO, and more power in a broad beta frequency range (16.3–40 Hz, peak: 19 Hz) globally during EC. Source estimates suggested global rather than cortically localized group differences. Conclusions: The widespread high power in a broad beta band reported previously during sleep in insomnia is present as well during eyes closed wakefulness, suggestive of a round-the-clock hyperarousal. Low power in the upper alpha band during eyes open is consistent with low cortical inhibition and attentional filtering. The fine-grained HD-EEG findings suggest that, while more feasible than PSG, wake EEG of short duration with a few well-chosen electrodes and frequency bands, can provide valuable features of insomnia. Citation: Colombo MA, Ramautar JR, Wei Y, Gomez-Herrero G, Stoffers D, Wassing R, Benjamins JS, Tagliazucchi E, van der Werf YD, Cajochen C, Van Someren EJW. Wake high-density electroencephalographic spatiospectral

  14. Insomnia severity is an indicator of suicidal ideation during a depression clinical trial.

    Science.gov (United States)

    McCall, W Vaughn; Blocker, Jill N; D'Agostino, Ralph; Kimball, James; Boggs, Niki; Lasater, Barbara; Rosenquist, Peter B

    2010-10-01

    Insomnia has been linked to suicidal ideas and suicide death in cross-sectional and longitudinal population-based studies. A link between insomnia and suicide has not been previously examined in the setting of a clinical trial. Herein we describe the relationship between insomnia and suicidal thinking during the course of a clinical trial for depression with insomnia. Sixty patients aged 41.5±12.5 years (2/3 women) with major depressive episode and symptoms of insomnia received open-label fluoxetine for 9 weeks and also received blinded, randomized eszopiclone 3mg or placebo at bedtime after the first week of fluoxetine. Insomnia symptoms were assessed with the Insomnia Severity Index (ISI), and suicidal ideation was assessed with The Scale for Suicide Ideation (SSI). Depression symptoms were assessed with the depressed mood item and the anhedonia item from the Hamilton Rating Scale for Depression-24 (HRSD24), as well as a sum score for all non-sleep and non-suicide items from the HRSD (HRSD20). Measurements were taken at baseline and weeks 1, 2, 4, 6, and 8. SSI was examined by generalized linear mixed models for repeated measures as the outcome of interest for all 60 participants with ISI and various mood symptoms as independent variables, with adjustment for age, gender, treatment assignment, and baseline SSI. Higher levels of insomnia corresponded to significantly greater intensity of suicidal thinking (pmodel, the ISI remained an independent predictor of suicidal thinking. The results support the concept that insomnia may be a useful indicator for suicidal ideation and now extend this idea into clinical trials. Insomnia remains an independent indicator of suicidal ideation, even taking into account the core symptoms of depression such as depressed mood and anhedonia. The complaint of insomnia during a depression clinical trial might indicate that more direct questioning about suicide is warranted.

  15. Persistent Insomnia: the Role of Objective Short Sleep Duration and Mental Health

    Science.gov (United States)

    Vgontzas, Alexandros N.; Fernandez-Mendoza, Julio; Bixler, Edward O.; Singareddy, Ravi; Shaffer, Michele L.; Calhoun, Susan L.; Liao, Duanping; Basta, Maria; Chrousos, George P.

    2012-01-01

    Study Objectives: Few population-based, longitudinal studies have examined risk factors for persistent insomnia, and the results are inconsistent. Furthermore, none of these studies have examined the role of polysomnographic (PSG) variables such as sleep duration or sleep apnea on the persistence of insomnia. Design: Representative longitudinal study. Setting: Sleep laboratory. Participants: From a random, general population sample of 1741 individuals of the adult Penn State Cohort, 1395 were followed-up after 7.5 years. Measurements: Individuals underwent one-night PSG and full medical evaluation at baseline and a telephone interview at follow-up. PSG sleep duration was analyzed as a continuous variable and as a categorical variable: insomnia persistence, partial remission, and full remission were 44.0%, 30.0%, and 26.0%, respectively. Objective short sleep duration significantly increased the odds of persistent insomnia as compared to normal sleep (OR = 3.19) and to fully remitted insomnia (OR = 4.92). Mental health problems at baseline were strongly associated with persistent insomnia as compared to normal sleep (OR = 9.67) and to a lesser degree compared to fully remitted insomnia (OR = 3.68). Smoking, caffeine, and alcohol consumption and sleep apnea did not predict persistent insomnia. Conclusions: Objective short sleep duration and mental health problems are the strongest predictors of persistent insomnia. These data further support the validity and clinical utility of objective short sleep duration as a novel marker of the biological severity of insomnia. Citation: Vgontzas AN; Fernandez-Mendoza J; Bixler EO; Singareddy R; Shaffer ML; Calhoun SL; Liao D; Basta M; Chrousos GP. Persistent insomnia: the role of objective short sleep duration and mental health. SLEEP 2012;35(1):61-68. PMID:22215919

  16. The heritability of insomnia progression during childhood/adolescence: results from a longitudinal twin study.

    Science.gov (United States)

    Barclay, Nicola L; Gehrman, Philip R; Gregory, Alice M; Eaves, Lindon J; Silberg, Judy L

    2015-01-01

    To determine prevalence and heritability of insomnia during middle/late childhood and adolescence; examine longitudinal associations in insomnia over time; and assess the extent to which genetic and environmental factors on insomnia remain stable, or whether new factors come into play, across this developmental period. Longitudinal twin study. Academic medical center. There were 739 complete monozygotic twin pairs (52%) and 672 complete dizygotic twin pairs (48%) initially enrolled and were followed up at three additional time points (waves). Mode ages at each wave were 8, 10, 14, and 15 y (ages ranged from 8-18 y). None. Clinical ratings of insomnia symptoms were assessed using the Child and Adolescent Psychiatric Assessment (CAPA) by trained clinicians, and rated according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-III-R criteria for presence of 'clinically significant insomnia', over four sequential waves. Insomnia symptoms were prevalent but significantly decreased across the four waves (ranging from 16.6% to 31.2%). 'Clinically significant insomnia' was moderately heritable at all waves (h² range = 14% to 38%), and the remaining source of variance was the nonshared environment. Multivariate models indicated that genetic influences at wave 1 contributed to insomnia at all subsequent waves, and that new genetic influences came into play at wave 2, which further contributed to stability of symptoms. Nonshared environmental influences were time-specific. Insomnia is prevalent in childhood and adolescence, and is moderately heritable. The progression of insomnia across this developmental time period is influenced by stable as well as new genetic factors that come into play at wave 2 (modal age 10 y). Molecular genetic studies should now identify genes related to insomnia progression during childhood and adolescence. © 2014 Associated Professional Sleep Societies, LLC.

  17. A Computerized Cognitive behavioral therapy Randomized, Controlled, pilot trial for insomnia in Parkinson Disease (ACCORD-PD)

    OpenAIRE

    Patel, Shnehal; Ojo, Oluwadamilola; Genc, Gencer; Oravivattanakul, Srivadee; Huo, Yang; Rasameesoraj, Tanaporn; Wang, Lu; Bena, James; Drerup, Michelle; Foldvary-Schaefer, Nancy; Ahmed, Anwar; Fernandez, Hubert H.

    2017-01-01

    Background Parkinson disease (PD) is associated with a high prevalence of insomnia, affecting up to 88% of patients. Pharmacotherapy studies in the literature addressing insomnia in PD reveal disappointing and inconsistent results. Cognitive behavioral therapy (CBT) is a novel treatment option with durable effects shown in primary insomnia. However, the lack of accessibility and expense can be limiting. For these reasons, computerized CBT for insomnia (CCBT-I) has been developed. The CCBT-I p...

  18. Relapse insomnia increases greater risk of anxiety and depression: evidence from a population-based 4-year cohort study.

    Science.gov (United States)

    Chen, Ping-Jen; Huang, Charles Lung-Cheng; Weng, Shih-Feng; Wu, Ming-Ping; Ho, Chung-Han; Wang, Jhi-Joung; Tsai, Wan-Chi; Hsu, Ya-Wen

    2017-10-01

    We investigated the longitudinal impacts of insomnia on the subsequent developments of anxiety and depression during a four-year follow-up. We further categorized individuals with insomnia into different insomnia subgroups to examine whether the risk of anxiety and depression varies by subtype. Participants were identified from National Health Insurance enrollees in Taiwan during 2002-2009. The study included 19,273 subjects with insomnia and 38,546 matched subjects without insomnia. All subjects did not have previous diagnosis of insomnia, sleep apnea, anxiety, or depression. Compared with non-insomniacs, insomniacs had a higher risk of developing anxiety only [adjusted hazard ratio (HR) = 8.83, 95% CI = 7.59-10.27], depression only (adjusted HR = 8.48, 95% CI = 6.92-10.39), and both anxiety and depression (adjusted HR = 17.98, 95% CI = 12.65-25.56). When breaking down the insomnia subgroups, individuals with a relapse of insomnia (adjusted HR = 10.42-26.80) had the highest risk of anxiety only, depression only, and both anxiety and depression, followed by persistent insomnia (adjusted HR = 9.82-18.98), then remitted insomnia (adjusted HR = 4.50-8.27). All three insomnia subgroups had a greater four-year cumulative incidence rate than the non-insomnia group for anxiety only, depression only, and both anxiety and depression (p anxiety or/and depression. Awareness of insomnia and treatment of insomnia should be recommended at clinics, and patterns of insomnia should be monitored to help treatment and control of subsequent psychiatric disorders. Future research with comprehensive data collection is needed to identify factors that contribute to different insomnia subtypes. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Guided Internet-delivered cognitive behavioural treatment for insomnia: a randomized trial.

    NARCIS (Netherlands)

    van Straten, A.; Emmelkamp, J.; de Wit, J.; Lancee, J.; Andersson, G.; van Someren, E.J.W.; Cuijpers, P.

    2014-01-01

    Background Insomnia is a prevalent problem with a high burden of disease (e.g. reduced quality of life, reduced work capacity) and a high co-morbidity with other mental and somatic disorders. Cognitive behavioural therapy (CBT) is effective in the treatment of insomnia but is seldom offered. CBT

  20. Guided Internet-delivered cognitive behavioural treatment for insomnia: a randomized trial

    NARCIS (Netherlands)

    van Straten, A.; Emmelkamp, J.; de Wit, J.; Lancee, J.; Andersson, G.; van Someren, E.J.W.; Cuijpers, P.

    2014-01-01

    Background: Insomnia is a prevalent problem with a high burden of disease (e.g. reduced quality of life, reduced work capacity) and a high co-morbidity with other mental and somatic disorders. Cognitive behavioural therapy (CBT) is effective in the treatment of insomnia but is seldom offered. CBT

  1. Guided Internet-delivered cognitive behavioural treatment for insomnia : a randomized trial

    NARCIS (Netherlands)

    van Straten, A; Emmelkamp, J; de Wit, J; Lancee, J; Andersson, G; van Someren, E J W; Cuijpers, P

    BACKGROUND: Insomnia is a prevalent problem with a high burden of disease (e.g. reduced quality of life, reduced work capacity) and a high co-morbidity with other mental and somatic disorders. Cognitive behavioural therapy (CBT) is effective in the treatment of insomnia but is seldom offered. CBT

  2. When thinking impairs sleep : Trait, daytime and nighttime repetitive thinking in insomnia

    NARCIS (Netherlands)

    Lancee, J.; Eisma, M.C.; van Zanten, K.B.; Topper, M.

    2017-01-01

    We performed two studies in individuals with sleep problems to investigate trait, daytime, and nighttime repetitive thinking as risk factors for insomnia. In Study 1, 139 participants completed questionnaires on worry, rumination, insomnia, anxiety, depression, and a sleep diary. Trait rumination

  3. Personality Disorder Features and Insomnia Status amongst Hypnotic-Dependent Adults

    Science.gov (United States)

    Ruiter, Megan E.; Lichstein, Kenneth L.; Nau, Sidney D.; Geyer, James

    2012-01-01

    Objective To determine the prevalence of personality disorders and their relation to insomnia parameters among persons with chronic insomnia with hypnotic dependence. Methods Eighty-four adults with chronic insomnia with hypnotic dependence completed the SCID-II personality questionnaire, two-weeks of sleep diaries, polysomnography, and measures of insomnia severity, impact, fatigue severity, depression, anxiety, and quality of life. Frequencies, between-subjects t-tests and hierarchical regression models were conducted. Results Cluster C personality disorders were most prevalent (50%). Obsessive-compulsive personality disorder (OCPD) was most common (n=39). These individuals compared to participants with no personality disorders did not differ in objective and subjective sleep parameters. Yet, they had poorer insomnia-related daytime functioning. OCPD and Avoidant personality disorders features were associated with poorer daytime functioning. OCPD features were related to greater fatigue severity, and overestimation of time awake was trending. Schizotypal and Schizoid features were positively associated with insomnia severity. Dependent personality disorder features were related to underestimating time awake. Conclusions Cluster C personality disorders were highly prevalent in patients with chronic insomnia with hypnotic dependence. Features of Cluster C and A personality disorders were variously associated with poorer insomnia-related daytime functioning, fatigue, and estimation of nightly wake-time. Future interventions may need to address these personality features. PMID:22938862

  4. Sleep Hygiene and Melatonin Treatment for Children and Adolescents with ADHD and Initial Insomnia

    Science.gov (United States)

    Weiss, Margaret D.; Wasdell, Michael B.; Bomben, Melissa M.; Rea, Kathleen J.; Freeman, Roger D.

    2006-01-01

    Objective: To evaluate the efficacy of sleep hygiene and melatonin treatment for initial insomnia in children with attention-deficit/hyperactivity disorder (ADHD). Method: Twenty-seven stimulant-treated children (6-14 years of age) with ADHD and initial insomnia (greater than 60 minutes) received sleep hygiene intervention. Nonresponders were…

  5. Insomnia heterogeneity : Characteristics to consider for data-driven multivariate subtyping

    NARCIS (Netherlands)

    Benjamins, Jeroen S; Migliorati, Filippo; Dekker, Kim; Wassing, Rick; Moens, Sarah; Blanken, Tessa F; Te Lindert, Bart H W; Sjauw Mook, Jeffrey; Van Someren, Eus J W

    2017-01-01

    Meta-analyses and systematic reviews have reported surprisingly few consistent insomnia-characteristics with respect to cognitions, mood, traits, history of life events and family history. One interpretation of this limited consistency is that different subtypes of insomnia exist, each with its own

  6. Insomnia heterogeneity: Characteristics to consider for data-driven multivariate subtyping.

    NARCIS (Netherlands)

    Benjamins, Jeroen S; Migliorati, Filippo; Dekker, Kim; Wassing, Rick; Moens, Sarah; Blanken, Tessa F; Te Lindert, Bart H W; Sjauw Mook, Jeffrey; Van Someren, Eus J W

    2017-01-01

    Meta-analyses and systematic reviews have reported surprisingly few consistent insomnia-characteristics with respect to cognitions, mood, traits, history of life events and family history. One interpretation of this limited consistency is that different subtypes of insomnia exist, each with its own

  7. Insomnia management in prisons in England and Wales: a mixed-methods study.

    Science.gov (United States)

    Dewa, Lindsay H; Hassan, Lamiece; Shaw, Jenny J; Senior, Jane

    2017-06-01

    Insomnia in prison is common; however, research is limited regarding the management strategies that prison establishments employ. To address this knowledge gap, we conducted a survey to identify how insomnia is detected, diagnosed and treated in adult prisons in England and Wales. Telephone interviews with a purposive sample of health-care managers were then conducted. The survey was sent to all establishments holding adult prisoners, covering screening and assessment methods to detect insomnia; treatment options, both pharmacological and non-pharmacological; the importance of insomnia as a treatable condition; and staff training available. Eighty-four (73%) prisons completed the survey. Few had a stepped approach to insomnia management, as recommended by National Institute for Health and Care Excellence (NICE) guidelines. The most common treatments available were sleep hygiene education and medication, offered by 94 and 88% of respondents, respectively. Analysis of telephone interviews revealed four main themes: insomnia as a normal occurrence in prison; the problem of medication in prison; the negative impact of the prison environment; and effective management of insomnia in prison. The current findings suggest that logistical, ethical and security barriers and a lack of staff knowledge and training impact negatively on the management of insomnia in prison. © 2017 European Sleep Research Society.

  8. Prediction of insomnia severity based on cognitive, metacognitive, and emotional variables in college students.

    Science.gov (United States)

    Doos Ali Vand, Hoda; Gharraee, Banafsheh; Farid, Ali-Asghar Asgharnejad; Bandi, MirFarhad Ghaleh

    2014-01-01

    Insomnia is the most common sleep disorder whose origin is attributed to various variables. The current study aims to predict the symptoms of insomnia by investigating some of its predictors. Numerous variables such as depression and anxiety symptoms, worry, pre-sleep arousal (cognitive arousal and somatic arousal), dysfunctional cognitions, and metacognitive beliefs about sleep were assessed as insomnia predictors. A total of 400 students of Tehran University of Medical Sciences completed the Depression Anxiety Stress Scale (DASS), the Penn State Worry Questionnaire (PSWQ), the Pre-Sleep Arousal Scale (PSAS), the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-10), the Metacognitions Questionnaire-Insomnia (MCQ-I), and the Insomnia Severity Index (ISI). All variables were significantly correlated with insomnia symptoms (P sleep, metacognitive beliefs about sleep, and depressive symptoms. The findings underline the significant role of cognitive and metacognitive variables for predicting insomnia symptoms. Moreover, the results suggest that metacognitive beliefs about sleep may need to be considered as a significant component in the context of insomnia. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Group Cognitive-Behavioral Therapy for Insomnia in a VA Mental Health Clinic

    Science.gov (United States)

    Perlman, Lawrence M.; Arnedt, J. Todd; Earnheart, Kristie L.; Gorman, Ashley A.; Shirley, Katherine G.

    2008-01-01

    Effective cognitive-behavioral therapies for insomnia have been developed over the past 2 decades, but they have not been systematically evaluated in some clinical settings. While insomnia is common among veterans with mental health problems, the availability of effective treatments is limited. We report on the group application of a…

  10. Improvements of adolescent psychopathology after insomnia treatment: results from a randomized controlled trial over 1 year

    NARCIS (Netherlands)

    de Bruin, Eduard J.; Bögels, Susan M.; Oort, Frans J.; Meijer, Anne Marie

    2017-01-01

    Adolescent insomnia can be treated effectively with cognitive behavioural therapy for insomnia (CBTI). However, little is known about effects of CBTI on psychopathology in adolescents. This study aimed to investigate whether (a) CBTI improves psychopathology in Internet- (IT) and face-to-face group

  11. Nocturnal heart rate variability in patients treated with cognitive-behavioral therapy for insomnia.

    Science.gov (United States)

    Jarrin, Denise C; Chen, Ivy Y; Ivers, Hans; Lamy, Manon; Vallières, Annie; Morin, Charles M

    2016-06-01

    Insomnia and reduced heart rate variability (HRV) increase the risk of cardiovascular disease and its precursors; thus, it is important to evaluate whether treatment for insomnia provides cardiovascular safeguards. The present study aimed to evaluate potential cardiovascular benefits of cognitive behavioral therapy for insomnia (CBT-I). The present study included 65 patients treated for chronic insomnia (M = 51.8 years, SD = 10.0; 66.2% female) at a university hospital. Patients received CBT-I over a 6-week period, and change scores from pre- to posttreatment derived from the Insomnia Severity Index, sleep diary, and polysomnography (PSG) were used as indices of sleep improvement. HRV variables (i.e., low frequency [LF], high frequency [HF], and the ratio of low to high frequency [LF:HF ratio]) were derived for Stage 2 (S2) and rapid-eye movement (REM) sleep at pre- and posttreatment. High HF (i.e., parasympathetic activity) and/or low LF:HF ratio (i.e., sympathovagal balance) were used as indices of HRV improvement. Following therapy, sleep improvements, particularly for sleep onset latency, were related with reduced HF in S2 (r = .30, p insomnia symptoms and increased HF in REM (r = -.21, p insomnia treatment might play a role in physiological changes associated with cardiovascular anomalies. Future research is needed to examine the long-term impact of treatment as a preventative tool against insomnia-related morbidity. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  12. Insomnia Phenotypes Based on Objective Sleep Duration in Adolescents: Depression Risk and Differential Behavioral Profiles

    Directory of Open Access Journals (Sweden)

    Julio Fernandez-Mendoza

    2016-12-01

    Full Text Available Based on previous studies on the role of objective sleep duration in predicting morbidity in individuals with insomnia, we examined the role of objective sleep duration in differentiating behavioral profiles in adolescents with insomnia symptoms. Adolescents from the Penn State Child Cohort (n = 397, ages 12–23, 54.7% male underwent a nine-hour polysomnography (PSG, clinical history, physical examination and psychometric testing, including the Child or Adult Behavior Checklist and Pediatric Behavior Scale. Insomnia symptoms were defined as a self-report of difficulty falling and/or staying asleep and objective “short” sleep duration as a PSG total sleep time ≤7 h. A significant interaction showed that objective short sleep duration modified the association of insomnia symptoms with internalizing problems. Consistently, adolescents with insomnia symptoms and short sleep duration were characterized by depression, rumination, mood dysregulation and social isolation, while adolescents with insomnia symptoms and normal sleep duration were characterized by rule-breaking and aggressive behaviors and, to a lesser extent, rumination. These findings indicate that objective sleep duration is useful in differentiating behavioral profiles among adolescents with insomnia symptoms. The insomnia with objective short sleep duration phenotype is associated with an increased risk of depression earlier in the lifespan than previously believed.

  13. Differential effects of online insomnia treatment on executive functions in adolescents

    NARCIS (Netherlands)

    de Bruin, E.J.; Dewald-Kaufmann, J.F.; Oort, F.J.; Bögels, S.M.; Meijer, A.M.

    2015-01-01

    Objective: To examine the effects of online Cognitive Behavior Therapy for Insomnia (CBTI) on adolescents' sleep and cognitive functioning. Methods: 32 adolescents (13-19 years, M = 15.9, SD = 1.6) with DSM-5 insomnia disorder, were randomly assigned to a treatment group (n = 18) or a waiting list

  14. The effect of support on Internet-delivered treatment for insomnia: Does baseline depression severity matter?

    NARCIS (Netherlands)

    Lancee, J.; Sorbi, M.J.; Eisma, M.C.; van Straten, A.; van den Bout, J.

    2014-01-01

    Internet-delivered cognitive-behavioral treatment is effective for insomnia. However, little is known about the beneficial effects of support. Recently we demonstrated that motivational support moderately improved the effects of Internet-delivered treatment for insomnia. In the present study, we

  15. Insomnia with objective short sleep duration: the most biologically severe phenotype of the disorder.

    Science.gov (United States)

    Vgontzas, Alexandros N; Fernandez-Mendoza, Julio; Liao, Duanping; Bixler, Edward O

    2013-08-01

    Until recently, the association of chronic insomnia with significant medical morbidity was not established and its diagnosis was based solely on subjective complaints. We present evidence that insomnia with objective short sleep duration is the most biologically severe phenotype of the disorder, as it is associated with cognitive-emotional and cortical arousal, activation of both limbs of the stress system, and a higher risk for hypertension, impaired heart rate variability, diabetes, neurocognitive impairment, and mortality. Also, it appears that objective short sleep duration is a biological marker of genetic predisposition to chronic insomnia. In contrast, insomnia with objective normal sleep duration is associated with cognitive-emotional and cortical arousal and sleep misperception but not with signs of activation of both limbs of the stress system or medical complications. Furthermore, the first phenotype is associated with unremitting course, whereas the latter is more likely to remit. We propose that short sleep duration in insomnia is a reliable marker of the biological severity and medical impact of the disorder. Objective measures of sleep obtained in the home environment of the patient would become part of the routine assessment of insomnia patients in a clinician's office setting. We speculate that insomnia with objective short sleep duration has primarily biological roots and may respond better to biological treatments, whereas insomnia with objective normal sleep duration has primarily psychological roots and may respond better to psychological interventions alone. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. (Mis)perception of Sleep in Insomnia: A Puzzle and a Resolution

    Science.gov (United States)

    Harvey, Allison G.; Tang, Nicole K. Y.

    2012-01-01

    Insomnia is prevalent, causing severe distress and impairment. This review focuses on illuminating the puzzling finding that many insomnia patients misperceive their sleep. They overestimate their sleep onset latency (SOL) and underestimate their total sleep time (TST), relative to objective measures. This tendency is ubiquitous (although not…

  17. Zolpidem is not superior to temazepam with respect to rebound insomnia: a controlled study.

    NARCIS (Netherlands)

    Oude Voshaar, R.C.; Balkom, A.J.L.M. van; Zitman, F.G.

    2004-01-01

    This randomised controlled trial was conducted to compare zolpidem to an equivalent dose of temazepam with respect to subjective rebound insomnia after cessation of 4 weeks of treatment in chronic insomnia (zolpidem 10 mg, n=79; temazepam 20 mg, n=84). Both agents improved total sleep time (TST) as

  18. Insomnia with Objective Short Sleep Duration: the Most Biologically Severe Phenotype of the Disorder

    Science.gov (United States)

    Vgontzas, Alexandros N.; Fernandez-Mendoza, Julio; Liao, Duanping; Bixler, Edward O.

    2013-01-01

    Summary Until recently, the association of chronic insomnia with significant medical morbidity was not established and its diagnosis was based solely on subjective complaints. We present evidence that insomnia with objective short sleep duration is the most biologically severe phenotype of the disorder, as it is associated with cognitive-emotional and cortical arousal, activation of both limbs of the stress system, and a higher risk for hypertension, impaired heart rate variability, diabetes, neurocognitive impairment, and mortality. Also, it appears that objective short sleep duration is a biological marker of genetic predisposition to chronic insomnia. In contrast, insomnia with objective normal sleep duration is associated with cognitive-emotional and cortical arousal and sleep misperception but not with signs of activation of both limbs of the stress system or medical complications. Furthermore, the first phenotype is associated with unremitting course, whereas the latter is more likely to remit. We propose that short sleep duration in insomnia is a reliable marker of the biological severity and medical impact of the disorder. Objective measures of sleep obtained in the home environment of the patient would become part of the routine assessment of insomnia patients in a clinician’s office setting. We speculate that insomnia with objective short sleep duration has primarily biological roots and may respond better to biological treatments, whereas insomnia with objective normal sleep duration has primarily psychological roots and may respond better to psychological interventions alone. PMID:23419741

  19. Insomnia and Its Temporal Association with Academic Performance among University Students : A Cross-Sectional Study

    NARCIS (Netherlands)

    Haile, Yohannes Gebreegziabhere; Alemu, Sisay Mulugeta; Habtewold, Tesfa Dejenie

    2017-01-01

    INTRODUCTION: Studies show that 9.4% to 38.2% of university students are suffering from insomnia. However, research data in developing countries is limited. Thus, the aim of the study was to assess insomnia and its temporal association with academic performance. METHODS AND MATERIALS: Institution

  20. Insomnia and Its Temporal Association with Academic Performance among University Students: A Cross-Sectional Study

    Directory of Open Access Journals (Sweden)

    Yohannes Gebreegziabhere Haile

    2017-01-01

    Full Text Available Introduction. Studies show that 9.4% to 38.2% of university students are suffering from insomnia. However, research data in developing countries is limited. Thus, the aim of the study was to assess insomnia and its temporal association with academic performance. Methods and Materials. Institution based cross-sectional study was conducted with 388 students at Debre Berhan University. Data were collected at the nine colleges. Logistic and linear regression analysis was performed for modeling insomnia and academic performance with a p value threshold of 0.05, respectively. Data were entered using EPI-data version 3.1 and analyzed using SPSS version 20. Results. The prevalence of insomnia was 61.6%. Field of study (p value = 0.01, worshiping frequency (p value = 0.048, marital status (p value = 0.03, and common mental disorder (p value < 0.001 were identified associated factors of insomnia. There was no significant association between insomnia and academic performance (p value = 0.53, β = −0.04. Insomnia explained 1.2% (r2 = 0.012 of the difference in academic performance between students. Conclusions. Nearly 3 out of 5 students had insomnia. We recommended that universities would endorse sleep quality and mental health illness screening programs for students.

  1. Brief Behavioral Interventions for Symptoms of Depression and Insomnia in University Primary Care

    Science.gov (United States)

    Funderburk, Jennifer S.; Shepardson, Robyn L.; Krenek, Marketa

    2015-01-01

    Objective: To describe how behavioral activation (BA) for depression and stimulus control (SC) for insomnia can be modified to a brief format for use in a university primary care setting, and to evaluate preliminarily their effectiveness in reducing symptoms of depression and insomnia, respectively, using data collected in routine clinical care.…

  2. Insomnia Symptoms, Nightmares, and Suicide Risk: Duration of Sleep Disturbance Matters

    Science.gov (United States)

    Nadorff, Michael R.; Nazem, Sarra; Fiske, Amy

    2013-01-01

    Duration of insomnia symptoms or nightmares was investigated to see if it was related to suicide risk independent of current insomnia symptoms, nightmares, anxiety symptoms, depressive symptoms, and posttraumatic symptoms. The cross-sectional study involved analyses of survey responses from undergraduate students who endorsed either insomnia…

  3. Early-life origin of adult insomnia : Does prenatal-early-life stress play a role?

    NARCIS (Netherlands)

    Palagini, Laura; Drake, Christopher L; Gehrman, Philip; Meerlo, Peter; Riemann, Dieter

    2015-01-01

    Insomnia is very common in the adult population and it includes a wide spectrum of sequelae, that is, neuroendocrine and cardiovascular alterations as well as psychiatric and neurodegenerative disorders. According to the conceptualization of insomnia in the context of the 3-P model, the importance

  4. Insomnia, Sleep Duration, Depressive Symptoms, and the Onset of Chronic Multisite Musculoskeletal Pain.

    Science.gov (United States)

    Generaal, Ellen; Vogelzangs, Nicole; Penninx, Brenda W J H; Dekker, Joost

    2017-01-01

    The temporal relationships among sleep, depressive symptoms, and pain are unclear. This longitudinal study examines whether insomnia and sleep duration predict the onset of chronic multisite musculoskeletal pain over 6 years and whether this association is mediated by depressive symptoms. 1860 subjects of the Netherlands Study of Depression and Anxiety, free from chronic multisite musculoskeletal pain at baseline, were followed up for the onset of chronic multisite musculoskeletal pain over 6 years (Chronic Pain Grade Questionnaire). We determined baseline insomnia (Women's Health Initiative Insomnia Rating Scale ≥9) and sleep duration (short: ≤6 hr, normal: 7-9 hr, long: ≥10 hr). Depressive symptoms were assessed at baseline and as a change score over time (Inventory of Depressive Symptomatology). Insomnia (hazard ratio [HR] [95% confidence interval, 95%CI] = 1.60 [1.30-1.96], p insomnia and short sleep with chronic pain onset (∆B = 40% and 26%, respectively). Adding the change score of depressive symptoms further weakened the association for insomnia (∆B = 16%) but not for short sleep. All direct effects for sleep measures with chronic pain onset remained statistically significant (p insomnia and short sleep duration are risk factors for developing chronic pain. Depressive symptoms partially mediate the effect for insomnia and short sleep with developing chronic pain. © Sleep Research Society 2016. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  5. An Investigation of the Prevalence of Insomnia in College Students and Its Relationship to Trait Anxiety

    Science.gov (United States)

    Sadigh, Micah R.; Himmanen, Sharon A.; Scepansky, James A.

    2014-01-01

    A number of empirical studies have established that insomnia, poor or inefficient sleep, can significantly impact physical and psychological well-being of college students, as well as interfere with their academic success. A major contributor to the experience of insomnia is that of persistent anxiety. In this study, we investigated the prevalence…

  6. Insomnia in childhood and adolescence: clinical aspects, diagnosis, and therapeutic approach

    Directory of Open Access Journals (Sweden)

    Magda Lahorgue Nunes

    2015-11-01

    Conclusions: Insomnia complaints in children and adolescents should be taken into account and appropriately investigated by the pediatrician, considering the association with several comorbidities, which must also be diagnosed. The main causes of insomnia and triggering factors vary according to age and development level. The therapeutic approach must include sleep hygiene and behavioral techniques and, in individual cases, pharmacological treatment.

  7. Adult insecure attachment plays a role in hyperarousal and emotion dysregulation in Insomnia Disorder.

    Science.gov (United States)

    Palagini, Laura; Petri, Eleonora; Novi, Martina; Caruso, Danila; Moretto, Umberto; Riemann, Dieter

    2018-04-01

    Studies show that unhelpful cognitive processes play a role in insomnia, whereas interpersonal factors have been less studied in insomnia. Attachment theory can be used as a cognitive-interpersonal framework for understanding insomnia. Because attachment insecurity (vs security) is related to psychiatric disorders the objective was to study the attachment style in insomnia. To this aim sixty-four subjects with Insomnia Disorder (DSM-5) and 38 good sleepers were evaluate in a cross-sectional study with: Attachment Style Questionnaire (ASQ), Arousal Predisposition Scale (APS), Pre-Sleep Arousal Scale (PSAS) and Difficulties in Emotion Regulation Scale (DERS). Differences in means between groups were assessed using t-test or Mann-Whitney U/Wilcoxon test. Linear/multiple regression analyses were performed. Subjects with insomnia (mean age 47.1 + 13 yrs) presented an insecure attachment style and higher scores in all the scales (ASQ, APS, PSAS, DERS p attachment was related to hyperarousal trait (p = 0.02), pre-sleep hyperarousal (p = 0.04) and emotion dysregulation (p = 0.002). In conclusion subjects with insomnia showed an insecure attachment which was related to hyperarousal trait, pre-sleep hyperarousal and emotion dysregulation. It may intervene in the trajectory of insomnia starting from predisposition to perpetuation. Clinical implications are discussed. Copyright © 2018 Elsevier B.V. All rights reserved.

  8. Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia : A Randomized Waitlist Controlled Trial

    NARCIS (Netherlands)

    Horsch, C.H.G.; Lancee, J.; Griffioen-Both, F.; Spruit, S.; Fitrianie, S.; Neerincx, M.A.; Beun, R.J.; Brinkman, W.-P.

    Background: This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have

  9. Mobile Phone-Delivered Cognitive Behavioral Therapy for Insomnia : A Randomized Waitlist Controlled Trial

    NARCIS (Netherlands)

    Horsch, C.H.G.; Lancee, J; Griffioen-Both, Fiemke; Spruit, Sandor; Fitrianie, S.; Neerincx, M.A.; Beun, RJ; Brinkman, W.P.

    2017-01-01

    Background: This study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have

  10. The subjective meaning of sleep quality: a comparison of individuals with and without insomnia.

    Science.gov (United States)

    Harvey, Allison G; Stinson, Kathleen; Whitaker, Katriina L; Moskovitz, Damian; Virk, Harvinder

    2008-03-01

    "Sleep quality" is poorly defined yet ubiquitously used by researchers, clinicians and patients. While poor sleep quality is a key feature of insomnia, there are few empirical investigations of sleep quality in insomnia patients. Accordingly, our aim was to investigate the subjective meaning of sleep quality among individuals with insomnia and normal sleepers. Cross sectional between groups (insomnia vs. good sleeper). Analyses were conducted across three outcome variables: (1) a "Speak Freely" procedure in which participants' descriptions of good and poor sleep quality nights were analysed, (2) a "Sleep Quality Interview" in which participants judged the relative importance of variables included in previous research on sleep quality and (3) a sleep quality diary completed over seven consecutive nights. University Department of Psychiatry. Individuals with insomnia (n = 25) and normal sleepers (n = 28). N/A. Both the insomnia and normal sleeper groups defined sleep quality by tiredness on waking and throughout the day, feeling rested and restored on waking, and the number of awakenings they experienced in the night. The insomnia group had more requirements for judging sleep to be of good quality. The meaning of sleep quality among individuals with insomnia and normal sleepers was broadly similar. A comprehensive assessment of a patient's appraisal of their sleep quality may require an assessment of waking and daytime variables.

  11. [Sleep and insomnia markers in the general population].

    Science.gov (United States)

    Ohayon, M M; Lemoine, P

    2004-01-01

    Several epidemiological surveys performed in Western Europe reported a prevalence of insomnia symptoms between 20% and 40% of the general population. Women and elderly individuals were the most affected. Many events can occur during sleep and affect its quality. Daytime sleepiness, a consequence of lack of sleep and/or insomnia, is responsible for many road, work and domestic accidents. Therefore, insomnia may have important consequences both for individuals and society. This study performed in the non institutionalized French population reports the sleep habits of that population and the factors associated with insomnia. This epidemiological study was conducted with 5,622 subjects representative of the French general population. They were aged between 15 and 96 Years. The participation rate was 80.8%. The results showed that men and women have different sleep habits. Generally speaking, women went to bed about 12 minutes earlier than men and woke up later than men (psleep than men except between the ages of 55 and 74, where men slept significantly more than women. However, sleep efficiency was lower in women than in men who were over age 35. This was due to a greater frequency of nocturnal awakenings in women than in men. Sleep habits also changed with age: Bedtime became progressively earlier with advancing age and wake-up time was later when the subjects reached retirement age. Sleep latency progressively increased with age after 35. Similarly, disrupted sleep increased with age and was reported by more than half of subjects 75 years or older. We found also that evening or night workers showed irregularities in their sleep patterns: sleep latency was significantly longer - at least 12 minutes - compared to daytime and shift workers (psleep duration of about 30 minutes compared to shift workers, and 40 minutes compared to daytime workers (psleep efficiency compared to daytime workers. Finally, in regions with greater density population (>100,000 inhabitants

  12. Improving insomnia in primary care patients: A randomized controlled trial of nurse-led group treatment.

    Science.gov (United States)

    Sandlund, Christina; Hetta, Jerker; Nilsson, Gunnar H; Ekstedt, Mirjam; Westman, Jeanette

    2017-07-01

    Insomnia is a common health problem, and most people who seek help for insomnia consult primary care. In primary care, insomnia treatment typically consists of hypnotic drugs, although cognitive behavioral therapy for insomnia is the recommended treatment. However, such treatment is currently available to few primary care patients. To evaluate the effects of a group treatment program for insomnia led by nurses in primary care. were the Insomnia Severity Index, a 2-week sleep diary, and a questionnaire on frequency of hypnotic drug use. A randomized controlled trial with pre- and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Routine primary health care; 7 primary care centers in Stockholm, Sweden. Patients consulting primary care for insomnia were assessed for eligibility. To be included, patients had to have insomnia disorder and be 18 years or older. Patients were excluded if they if they worked night shifts or had severe untreated somatic and/or mental illness, bipolar disorder, or untreated sleep disorder other than insomnia. One-hundred and sixty-five patients 20 to 90 years were included. Most were women, and many had co-existing somatic and/or mental health problems. The post-treatment dropout rate was 20%. The intervention was a nurse-led group treatment for insomnia based on the techniques of cognitive behavioral therapy for insomnia. The nurses had 2days of training in how to deliver the program. Ninety patients were randomized to the intervention and 75 to the control group (treatment as usual). Data from 82 in the intervention and 71 in the control group were analyzed in accordance with intention-to-treat principles. Fifty-four of the 72 in the intervention group who participated in the group treatment program were followed up after 1year. Mean Insomnia Severity Index score decreased significantly from 18.4 to 10.7 after group treatment but remained unchanged after treatment as usual (17.0 to 16.6). The effect

  13. Melatonin and its analogs in insomnia and depression.

    Science.gov (United States)

    Cardinali, Daniel P; Srinivasan, Venkataramanujan; Brzezinski, Amnon; Brown, Gregory M

    2012-05-01

    Benzodiazepine sedative-hypnotic drugs are widely used for the treatment of insomnia. Nevertheless, their adverse effects, such as next-day hangover, dependence and impairment of memory, make them unsuitable for long-term treatment. Melatonin has been used for improving sleep in patients with insomnia mainly because it does not cause hangover or show any addictive potential. However, there is a lack of consistency on its therapeutic value (partly because of its short half-life and the small quantities of melatonin employed). Thus, attention has been focused either on the development of more potent melatonin analogs with prolonged effects or on the design of slow release melatonin preparations. The MT(1) and MT(2) melatonergic receptor ramelteon was effective in increasing total sleep time and sleep efficiency, as well as in reducing sleep latency, in insomnia patients. The melatonergic antidepressant agomelatine, displaying potent MT(1) and MT(2) melatonergic agonism and relatively weak serotonin 5HT(2C) receptor antagonism, was found effective in the treatment of depressed patients. However, long-term safety studies are lacking for both melatonin agonists, particularly considering the pharmacological activity of their metabolites. In view of the higher binding affinities, longest half-life and relative higher potencies of the different melatonin agonists, studies using 2 or 3mg/day of melatonin are probably unsuitable to give appropriate comparison of the effects of the natural compound. Hence, clinical trials employing melatonin doses in the range of 50-100mg/day are warranted before the relative merits of the melatonin analogs versus melatonin can be settled. © 2011 John Wiley & Sons A/S.

  14. Effectiveness of Cognitive- behavioral Group Therapy on Insomnia Symptoms in Students

    Directory of Open Access Journals (Sweden)

    A Abollahi

    2015-04-01

    Full Text Available Background & aim: Insomnias is associated with considerable problems in educational, vocational, social and familial performance. The purpose of present research was to investigate the effectiveness of Cognitive-Behavior group therapy on improvement of insomnia symptoms in students. Methods: The present clinical trial study was conducted on twenty-four students who were randomly assigned into two groups of case and the control (n = 12. The experimental group was participated in eight sessions of cognitive behavior therapy, while the control group received no intervention. Research tools include the Pittsburgh Sleep Quality Index and the Insomnia Severity Index that completed by both participants. Data were analyzed using ANOVA, t-test. Results: Analysis of covariance showed that the performance of cognitive behavioral therapy may improve symptoms and reduce the severity of insomnia in the experimental group compared with the control group (p < 0.05. Conclusion: Group cognitive-behavioral therapy is effective on symptoms of insomnia in students.

  15. A Test of the Bidirectional Association Between Sleep and Mood in Bipolar Disorder and Insomnia

    Science.gov (United States)

    Talbot, Lisa S.; Stone, Susan; Gruber, June; Hairston, Ilana S.; Eidelman, Polina; Harvey, Allison G.

    2012-01-01

    The present study investigates sleep, mood, and the proposed bidirectional relationship between the two in psychiatric disorders. Participants with interepisode bipolar disorder (n = 49), insomnia (n = 34), and no psychiatric history (n = 52) completed seven consecutive days of sleep diaries and mood measures. The interepisode bipolar and insomnia participants exhibited greater sleep disturbance than the healthy control individuals. Negative mood was equally heightened in both interepisode bipolar disorder and insomnia, and there were no differences between the three groups in positive mood. Total wake time was associated with next morning negative mood in bipolar disorder, whereas evening negative mood was associated with subsequent total wake time in both bipolar disorder and insomnia. Additionally, positive mood was associated with subsequent total wake time for the insomnia group. Results support the theory that disruptions in nighttime sleep and daytime mood may be mutually maintaining and suggest the potential importance of transdiagnostic or universal processes. PMID:21842957

  16. Psychometric Properties of the Consensus Sleep Diary in Those With Insomnia Disorder.

    Science.gov (United States)

    Maich, Kristin H G; Lachowski, Angela M; Carney, Colleen E

    2018-01-01

    The Consensus Sleep Diary (CSD) is a standardized, prospective tool for tracking nightly subjective sleep. The current study evaluated the validity and utility of the CSD, with consideration for challenges inherent to psychometric evaluation of diary measures. Results showed that the CSD indices differentiated good sleepers from those with insomnia