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Sample records for resistant insomnia post-marketing

  1. [Investigation of the factors that contribute to the onset of insomnia in hypertensive patients by using a post-marketing surveillance database].

    Science.gov (United States)

    Tanabe, Naoto; Fujita, Toshiharu; Fujii, Yosuke; Orii, Takao

    2011-01-01

    Many factors contribute to the onset of insomnia. However, few studies have identified the factors related to the onset of insomnia in hypertensive patients. We conducted a pharmacoepidemiologic study to examine the incidence of insomnia in hypertensive patients by using a post-marketing surveillance database. The insomnia onset was defined as the time of first prescription of hypnotics. The insomnia incidence rate in hypertensive patients under antihypertensive therapy was 0.77/100 person-years. The median insomnia onset date was 5 weeks. The insomnia type in 50.2% of the patients was difficulty in initiating sleep. We assessed the factors contributing to insomnia by using a nested case-control design. We selected 10 time-matched controls for every case. The hypotensive effect induced by antihypertensive therapy on the case group was lesser than that on the control group (pchannel blockers (OR, 0.62; 95% CI, 0.43-0.90) compared with angiotensin-converting enzyme inhibitors; female sex (OR, 1.76; 95% CI, 1.27-2.44); complication of gastric/duodenal disorders (OR, 2.35; 95% CI, 1.14-4.86) or musculoskeletal system/connective tissue disorders (OR, 2.43; 95% CI, 1.23-4.79); and concomitant antihypertensive therapy (OR, 0.44; 95% CI, 0.31-0.63). This study identified the potential factors that may help to predict insomnia onset in hypertensive patients under antihypertensive therapy.

  2. The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

    Science.gov (United States)

    Lens, S

    1993-06-01

    The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

  3. Insomnia

    Science.gov (United States)

    ... or chronic (ongoing). Acute insomnia is common. Common causes include stress at work, family pressures, or a traumatic event. It usually ... it is not caused by something else. Its cause is not well understood, but ... travel and shift work can be factors. Primary insomnia usually lasts more ...

  4. Insomnia

    Science.gov (United States)

    ... and others. Remaining passively awake. Also called paradoxical intention, this involves avoiding any effort to fall asleep. ... person for your sessions. However, phone consultation, CDs, books or websites on CBT techniques and insomnia also ...

  5. Insomnia

    Science.gov (United States)

    ... 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 Any use of this site ...

  6. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    Science.gov (United States)

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  7. [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.

  8. 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.

  9. 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....

  10. Insomnia in shift work.

    Science.gov (United States)

    Vallières, Annie; Azaiez, Aïda; Moreau, Vincent; LeBlanc, Mélanie; Morin, Charles M

    2014-12-01

    Shift work disorder involves insomnia and/or excessive sleepiness associated with the work schedule. The present study examined the impact of insomnia on the perceived physical and psychological health of adults working on night and rotating shift schedules compared to day workers. A total of 418 adults (51% women, mean age 41.4 years), including 51 night workers, 158 rotating shift workers, and 209 day workers were selected from an epidemiological study. An algorithm was used to classify each participant of the two groups (working night or rotating shifts) according to the presence or absence of insomnia symptoms. Each of these individuals was paired with a day worker according to gender, age, and income. Participants completed several questionnaires measuring sleep, health, and psychological variables. Night and rotating shift workers with insomnia presented a sleep profile similar to that of day workers with insomnia. Sleep time was more strongly related to insomnia than to shift work per se. Participants with insomnia in the three groups complained of anxiety, depression, and fatigue, and reported consuming equal amounts of sleep-aid medication. Insomnia also contributed to chronic pain and otorhinolaryngology problems, especially among rotating shift workers. Work productivity and absenteeism were more strongly related to insomnia. The present study highlights insomnia as an important component of the sleep difficulties experienced by shift workers. Insomnia may exacerbate certain physical and mental health problems of shift workers, and impair their quality of life. Copyright © 2014 Elsevier B.V. All rights reserved.

  11. 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.

  12. Genetic Pathways to Insomnia

    OpenAIRE

    Mackenzie J. Lind; Philip R. Gehrman

    2016-01-01

    This review summarizes current research on the genetics of insomnia, as genetic contributions are thought to be important for insomnia etiology. We begin by providing an overview of genetic methods (both quantitative and measured gene), followed by a discussion of the insomnia genetics literature with regard to each of the following common methodologies: twin and family studies, candidate gene studies, and genome-wide association studies (GWAS). Next, we summarize the most recent gene identif...

  13. 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.

  14. 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.

  15. 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…

  16. 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

  17. 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...

  18. 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 ...

  19. WHAT IS INSOMNIA

    Directory of Open Access Journals (Sweden)

    Nurzakiah binti Zaini

    2013-12-01

    Full Text Available Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 Insomnia is a sleep disorder with recurrent difficulty to sleep or maintaining sleep with symptoms tired all day. There are several types of insomnia, transient insomnia which is temporary insomnia, short-term insomnia that can last for several weeks, and chronic insomnia that can last for more than four weeks. Insomnia is caused by several factors, including physical factors such as suffering from certain diseases, environmental factors, psychological factors and psychiatric problems. To overcome this disorder we can use relaxation techniques, subconscious programming, and drug therapy. /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi;}

  20. 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.

  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

    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.

  2. [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

  3. Risk management and post-marketing surveillance of CNS drugs.

    Science.gov (United States)

    Henningfield, Jack E; Schuster, Charles R

    2009-12-01

    Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

  4. 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.

  5. 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

  6. 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

  7. [Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

    2011-10-01

    In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

  8. [Thought on several problems of clinical revaluation of post-marketing herb research].

    Science.gov (United States)

    He, Wei; Xie, Yanming; Wang, Yongyan

    2010-06-01

    The revaluation of post-marketing herb is a complex research work, which concerns widely content and difficult to put it into practice. The starting of our country's revaluation post-marketing herb was comparatively late. It should profect it both in laws and regulations mechanism as well as technological specification. This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-marketing herb.

  9. 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

  10. Drugs for insomnia.

    Science.gov (United States)

    Zisapel, Nava

    2012-09-01

    Sleep is a vital neurochemical process involving sleep-promoting and arousal centers in the brain. Insomnia is a pervasive disorder characterized by difficulties in initiating or maintaining or non-refreshing (poor quality) sleep and clinically significant daytime distress. Insomnia is more prevalent in women and old age and puts sufferers at significant physical and mental health risks. This review summarizes published data on the current and emerging insomnia drug classes, rationale for development and associated risks/benefits. (Summary of Product Characteristics and Medline search on "hypnotic" or specific drug names and "Insomnia"). GABA(A) receptor modulators facilitate sleep onset and some improve maintenance but increase risk of dependence, memory, cognitive and psychomotor impairments, falls, accidents and mortality. Melatonin receptor agonists improve quality of sleep and/or sleep onset but response may develop over several days. They have more benign safety profiles and are indicated for milder insomnia, longer usage and (prolonged release melatonin) older patients. Histamine H-1 receptor antagonists improve sleep maintenance but their effects on cognition, memory and falls remain to be demonstrated. Late-stage pipeline orexin OX1/OX2 and serotonin 5HT2A receptor antagonists may hold the potential to address several unmet needs in insomnia pharmacotherapy but safety issues cast some doubts over their future. Current and new insomnia drugs in the pipeline target different sleep regulating mechanisms and symptoms and have different tolerability profiles. Drug selection would ideally be based on improvement in the quality of patients' sleep, overall quality of life and functional status weighed against risk to the individual and public health.

  11. 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…

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. [Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance].

    Science.gov (United States)

    Zhang, Wen; Xie, Yan-Ming; Yu, Wen-Ya

    2013-09-01

    Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

  18. Insomnia in Iranian Traditional Medicine

    Science.gov (United States)

    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 the most famous ancient textbooks of Iranian traditional medicine from different centuries. This books includeThe Canon of Medicine by Avicenna (the first version of Beirut), Zakhire Kharazmshahi by Jurjani (the scanned version of Bonyade Farhang-e Iran), Malfaregh by Razes (the first version of Iran University of Medical Sciences), and Aqili’s cure by Aqili (the first version of Iran University of Medical Sciences). Results: This study found that in Iranian traditional medicine manuscripts, insomnia was called sahar and even though many factors induce insomnia, most of them act through causing brain dystemperament. Conclusions: The brain dystemperament is considered one of the main causes of insomnia and insomnia can be well managed with an organized line of treatment, by correcting the brain dystemperament through elimination of causes. This study helps to find new solutions to treat insomnia. PMID:24829786

  19. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

  20. 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.

  1. 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...

  2. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    Science.gov (United States)

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  3. 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...

  4. Arthritis, Rheumatism and Aging Medical Information System Post-Marketing Surveillance Program.

    Science.gov (United States)

    Singh, G

    2001-05-01

    The Arthritis, Rheumatism, and Aging Post-Marketing Surveillance Program (ARAMIS-PMS) is a collection of multicenter, prospective, noninterventional, observational longitudinal studies of patients with rheumatic diseases. The ARAMIS-PMS program aims to study patients in normal clinical setting to evaluate the real-life effectiveness, toxicity, and cost effectiveness of various medications used to treat rheumatic diseases.

  5. [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.

  6. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Fu, Yingkun; Xie, Yanming

    2011-10-01

    In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

  7. 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.

  8. Human physiological models of insomnia.

    Science.gov (United States)

    Richardson, Gary S

    2007-12-01

    Despite the wide prevalence and important consequences of insomnia, remarkably little is known about its pathophysiology. Available models exist primarily in the psychological domain and derive from the demonstrated efficacy of behavioral treatment approaches to insomnia management. However, these models offer little specific prediction about the anatomic or physiological foundation of chronic primary insomnia. On the other hand, a growing body of data on the physiology of sleep supports a reasonably circumscribed overview of possible pathophysiological mechanisms, as well as the development of physiological models of insomnia to guide future research. As a pragmatic step, these models focus on primary insomnia, as opposed to comorbid insomnias, because the latter is by its nature a much more heterogeneous presentation, reflecting the effects of the distinct comorbid condition. Current understanding of the regulation of sleep and wakefulness in mammalian brain supports four broad candidate areas: 1) disruption of the sleep homeostat; 2) disruption of the circadian clock; 3) disruption of intrinsic systems responsible for the expression of sleep states; or 4) disruption (hyperactivity) of extrinsic systems capable of over-riding normal sleep-wake regulation. This review examines each of the four candidate pathophysiological mechanisms and the available data in support of each. While studies that directly test the viability of each model are not yet available, descriptive data on primary insomnia favor the involvement of dysfunctional extrinsic stress-response systems in the pathology of primary chronic insomnia.

  9. [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.

  10. 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

  11. 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

  12. 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...

  13. 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.

  14. [Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

    Science.gov (United States)

    Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

    2014-09-01

    Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

  15. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    Science.gov (United States)

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

  16. 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 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.

  17. [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.

  18. 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.

  19. Stress Reactivity in Insomnia.

    Science.gov (United States)

    Gehrman, Philip R; Hall, Martica; Barilla, Holly; Buysse, Daniel; Perlis, Michael; Gooneratne, Nalaka; Ross, Richard J

    2016-01-01

    This study examined whether individuals with primary insomnia (PI) are more reactive to stress than good sleepers (GS). PI and GS (n = 20 per group), matched on gender and age, completed three nights of polysomnography. On the stress night, participants received a mild electric shock and were told they could receive additional shocks during the night. Saliva samples were obtained for analysis of cortisol and alpha amylase along with self-report and visual analog scales (VAS). There was very little evidence of increased stress on the stress night, compared to the baseline night. There was also no evidence of greater stress reactivity in the PI group for any sleep or for salivary measures. In the GS group, stress reactivity measured by VAS scales was positively associated with an increase in sleep latency in the experimental night on exploratory analyses. Individuals with PI did not show greater stress reactivity compared to GS.

  20. 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.

  1. 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.

  2. [Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

    Science.gov (United States)

    Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

    2013-09-01

    Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

  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

    2018-06-01

    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. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

    Science.gov (United States)

    Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

    2008-12-01

    We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

  5. 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...

  6. 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.

  7. 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)

  8. 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 =

  9. [Comparative study on four kinds of assessment methods of post-marketing safety of Danhong injection].

    Science.gov (United States)

    Li, Xuelin; Tang, Jinfa; Meng, Fei; Li, Chunxiao; Xie, Yanming

    2011-10-01

    To study the adverse reaction of Danhong injection with four kinds of methods, central monitoring method, chart review method, literature study method and spontaneous reporting method, and to compare the differences between them, explore an appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection. Set down the adverse reactions' questionnaire of four kinds of methods, central monitoring method, chart review method, literature study method and collect the information on adverse reactions in a certain period. Danhong injection adverse reaction information from Henan Province spontaneous reporting system was collected with spontaneous reporting method. Carry on data summary and descriptive analysis. Study the adverse reaction of Danhong injection with four methods of central monitoring method, chart review method, literature study method and spontaneous reporting method, the rates of adverse events were 0.993%, 0.336%, 0.515%, 0.067%, respectively. Cyanosis, arrhythmia, hypotension, sweating, erythema, hemorrhage dermatitis, rash, irritability, bleeding gums, toothache, tinnitus, asthma, elevated aminotransferases, constipation, pain are new discovered adverse reactions. The central monitoring method is the appropriate method to carry out post-marketing safety evaluation of traditional Chinese medicine injection, which could objectively reflect the real world of clinical usage.

  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. 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.

  12. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    Science.gov (United States)

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  13. 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.

  14. Sample size for post-marketing safety studies based on historical controls.

    Science.gov (United States)

    Wu, Yu-te; Makuch, Robert W

    2010-08-01

    As part of a drug's entire life cycle, post-marketing studies are an important part in the identification of rare, serious adverse events. Recently, the US Food and Drug Administration (FDA) has begun to implement new post-marketing safety mandates as a consequence of increased emphasis on safety. The purpose of this research is to provide exact sample size formula for the proposed hybrid design, based on a two-group cohort study with incorporation of historical external data. Exact sample size formula based on the Poisson distribution is developed, because the detection of rare events is our outcome of interest. Performance of exact method is compared to its approximate large-sample theory counterpart. The proposed hybrid design requires a smaller sample size compared to the standard, two-group prospective study design. In addition, the exact method reduces the number of subjects required in the treatment group by up to 30% compared to the approximate method for the study scenarios examined. The proposed hybrid design satisfies the advantages and rationale of the two-group design with smaller sample sizes generally required. 2010 John Wiley & Sons, Ltd.

  15. [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.

  16. Determinan Insomnia pada Lanjut Usia

    Directory of Open Access Journals (Sweden)

    Andi Zulkifli Abdullah

    2012-11-01

    Full Text Available Insomnia merupakan gangguan tidur yang paling sering ditemukan pada lanjut usia (lansia dengan prevalensi sekitar 67%. Penelitian ini bertujuan untuk menilai hubungan antara kecemasan, depresi, dukungan keluarga, dan kondisi lingkungan dengan kejadian insomnia pada lansia di Panti Sosial Tresna Werdha Gau Mabaji Kabupaten Gowa. Penelitian ini menggunakan desain studi observasional dengan rancangan cross sectional dan metode exhausive sampling. Data dianalisis dengan uji chi square, koefisien phi (f dengan a = 0,05. Sebanyak 96 lansia penghuni panti memenuhi kriteria penelitian. Uji chi square menunjukkan bahwa terdapat hubungan antara kecemasan (nilai p = 0,014; f = 0,251, depresi (nilai p = 0,019; f = 0,238, dukungan keluarga (nilai p = 0,000; f = 0,797, dan kondisi lingkungan panti (nilai p < 0,05; f = 0,238 dengan kejadian insomnia. Pemberian penyuluhan kepada keluarga lansia adalah salah satu kegiatan yang penting dilakukan untuk meningkatkan pengetahuan keluarga lansia bahwa lansia tidak hanya sekadar diperhatikan kebutuhan fisiknya tetapi juga kebutuhan psikologisnya. Kata kunci: Depresi, insomnia, kecemasan Abstract Insomnia is sleep disorder, most often found on elderly with high prevalence about 67%. The aim of this research is to prove the relation between anxiousness, depression, family support, and environmental condition with the occurence of insomnia at old ages in social institution Tresna Werdha Gau Mabaji Gowa Regency. This research used an observasional study with cross sectional design, using the exhausive sampling method. Data were analysed by chi square test, phi coefficient with a = 0,05. About 96 elderly in social institution met the research criteria, chi square test indicates that there are relation between anxiousness (p value = 0,014; f = 0,251, depression (p value = 0,019; f = 0,238, family support (p value = 0,000; f = 0,797, and environmental condition of social institution (p value = 0,019; f = 0,238 with the

  17. 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.

  18. 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.

  19. Insomnia, dreams, and suicide: Connecting links

    Directory of Open Access Journals (Sweden)

    Sagar B Karia

    2016-01-01

    Full Text Available Introduction: A growing empirical literature has examined insomnia symptoms as a possible risk factor for a range of suicidal behavior. Not much literature is available in normal adolescent population. Aims: The aim is to find insomnia prevalence, studying various dream factors, and suicidality prevalence among students of various courses. To check if there is a relation between insomnia and suicidal behavior and dreams, particularly nightmares and suicide. Materials and Methods: A total of 400 students of various courses were assessed using Insomnia Severity Index and The Mannheim Dream Questionnaire and Suicide Behaviour Questionnaire. Results: Insomnia was present in 11%, 23%, 19%, and 19% and suicide behavior in 16%, 17%, 12%, and 22%, respectively, in medical, commerce, engineering, and arts students. Statistically significant correlation was found between suicide and insomnia severity and various dream factors. Conclusions: Insomnia and dreams had relation with suicidality in normal adolescent population.

  20. 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 insomnia. © 2014 European Sleep Research Society.

  1. 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

  2. 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

  3. 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

  4. Decision support methods for the detection of adverse events in post-marketing data.

    Science.gov (United States)

    Hauben, M; Bate, A

    2009-04-01

    Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

  5. 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),

  6. [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.

  7. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    Science.gov (United States)

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2018-01-01

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  8. 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

  9. [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.

  10. 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.

  11. 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.

  12. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--I. Gram-positive bacteria].

    Science.gov (United States)

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, penicillins, and carbapenems. Changes in the bacterial susceptibility for CZOP were also evaluated with the resistance ratio calculated with breakpoint MIC. Sixteen species (2,363 strains) of Gram-positive bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus epidermidis (MSSE), methicillin-resistant Staphylococcus epidermidis (MRSE), Staphylococcus haemolyticus, Staphylococcus saprophyticus, Enterococcus faecalis, Enterococcus faecium, Enterococcus avium, Streptococcus pyogenes, Streptococcus agalactiae, penicillin-susceptible Streptococcus pneumoniae (PSSP), penicillin-intermediate resistant S. pneumoniae (PISP), penicillin-resistant S. pneumoniae (PRSP), Streptococcus milleri group and Peptostreptococcus spp. The antibacterial activity of CZOP either against MSSA or MSSE was preferable (MIC90: 2 or 0.5 micrograms/mL) and comparable to those of other cephems. CZOP was also effective on MRSE (MIC90: 16 micrograms/mL) but not on MRSA. CZOP and other cephems had low antibacterial activity against S. haemolyticus (MIC90: 64 micrograms/mL). The antibacterial activity of CZOP against S. saprophyticus was comparable to or higher than those of other cephems, but the MIC90 of CZOP in 2001 was higher than those in 1996-2000 (32 vs 1-2 micrograms/mL). The antibacterial activity of CZOP against E. faecalis was comparable to that of cefpirome (CPR; MIC90: 16 micrograms/mL) and higher than those of other cephems. No antibacterial activity of CZOP against E. faecium and E. avium was observed, like other drugs. The antibacterial activity of CZOP against S. pyogenes

  13. 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...

  14. The Nature of Stable Insomnia Phenotypes

    Science.gov (United States)

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

    2015-01-01

    Study Objectives: 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. Design: Longitudinal. Setting: Urban, community-based. Participants: 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). Interventions: None. Measurements and results: 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. Conclusions: By adopting a stringent, stability-based definition, this study offers timely and important data on the longitudinal trajectory of specific insomnia phenotypes. With

  15. Insomnia, dreams, and suicide: Connecting links

    OpenAIRE

    Sagar B Karia; Nirali Mehta; Devavrat Harshe; Avinash De Sousa; Nilesh Shah

    2016-01-01

    Introduction: A growing empirical literature has examined insomnia symptoms as a possible risk factor for a range of suicidal behavior. Not much literature is available in normal adolescent population. Aims: The aim is to find insomnia prevalence, studying various dream factors, and suicidality prevalence among students of various courses. To check if there is a relation between insomnia and suicidal behavior and dreams, particularly nightmares and suicide. Materials and Methods: A total of 4...

  16. 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.

  17. [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.

  18. Mining association patterns of drug-interactions using post marketing FDA's spontaneous reporting data.

    Science.gov (United States)

    Ibrahim, Heba; Saad, Amr; Abdo, Amany; Sharaf Eldin, A

    2016-04-01

    Pharmacovigilance (PhV) is an important clinical activity with strong implications for population health and clinical research. The main goal of PhV is the timely detection of adverse drug events (ADEs) that are novel in their clinical nature, severity and/or frequency. Drug interactions (DI) pose an important problem in the development of new drugs and post marketing PhV that contribute to 6-30% of all unexpected ADEs. Therefore, the early detection of DI is vital. Spontaneous reporting systems (SRS) have served as the core data collection system for post marketing PhV since the 1960s. The main objective of our study was to particularly identify signals of DI from SRS. In addition, we are presenting an optimized tailored mining algorithm called "hybrid Apriori". The proposed algorithm is based on an optimized and modified association rule mining (ARM) approach. A hybrid Apriori algorithm has been applied to the SRS of the United States Food and Drug Administration's (U.S. FDA) adverse events reporting system (FAERS) in order to extract significant association patterns of drug interaction-adverse event (DIAE). We have assessed the resulting DIAEs qualitatively and quantitatively using two different triage features: a three-element taxonomy and three performance metrics. These features were applied on two random samples of 100 interacting and 100 non-interacting DIAE patterns. Additionally, we have employed logistic regression (LR) statistic method to quantify the magnitude and direction of interactions in order to test for confounding by co-medication in unknown interacting DIAE patterns. Hybrid Apriori extracted 2933 interacting DIAE patterns (including 1256 serious ones) and 530 non-interacting DIAE patterns. Referring to the current knowledge using four different reliable resources of DI, the results showed that the proposed method can extract signals of serious interacting DIAEs. Various association patterns could be identified based on the relationships among

  19. Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing.

    Science.gov (United States)

    Wesolowski, Laura G; MacKellar, Duncan A; Facente, Shelley N; Dowling, Teri; Ethridge, Steven F; Zhu, Julia H; Sullivan, Patrick S

    2006-08-01

    Post-marketing surveillance was conducted to monitor the performance of the OraQuick Advance rapid HIV-1/2 antibody test (OraQuick) on whole blood and oral fluid. Surveillance of routinely collected data on clients tested with OraQuick in 368 testing sites affiliated with 17 state and city health departments between 11 August 2004 and 30 June 2005. For whole blood and oral fluid, we report the median (range) health department OraQuick specificity and positive predictive value (PPV), and the number of clients with discordant results (e.g. who had a reactive rapid test not confirmed positive by Western blot or indirect immunofluorescence). At one site with lower than expected oral-fluid specificity, we evaluated whether device expiration, manufacturing lot, operator practices, or device-storage or testing-area temperatures were associated with false-positive tests. During the surveillance period, 135 724 whole blood and 26 066 oral fluid rapid tests were conducted. The median health department whole blood OraQuick specificity was 99.98% (range: 99.73-100%) and PPV was 99.24% (range: 66.67-100%); the median oral fluid specificity was 99.89% (range: 99.44-100%) and PPV was 90.00% (range: 50.00-100%). A total of 124 discordant results were reported from 68 (0.05%) whole blood and 56 (0.22%) oral fluid rapid tests. The oral fluid specificity at the site with excess oral fluid false-positive tests was 98.7% (95% confidence interval: 98.18-99.11%). The increase in false-positive tests at that site was not associated with any specific device characteristic, operator procedure or temperature condition. The specificity of OraQuick performed on whole blood and oral fluid during post-marketing surveillance was compatible with the manufacturer's claim within the package insert. However, one site experienced lower than expected oral fluid specificity. Sites that observe that the specificity of OraQuick is lower than the range indicated in the package insert should notify the

  20. 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.

  1. Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

    Science.gov (United States)

    Sakoulas, G

    2009-12-01

    The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

  2. A temporal interestingness measure for drug interaction signal detection in post-marketing surveillance.

    Science.gov (United States)

    Ji, Yanqing; Ying, Hao; Tran, John; Dews, Peter; Mansour, Ayman; Massanari, R Michael

    2014-01-01

    Drug-drug interactions (DDIs) can result in serious consequences, including death. Existing methods for identifying potential DDIs in post-marketing surveillance primarily rely on the FDA's (Food and Drug Administration) spontaneous reporting system. However, this system suffers from severe underreporting, which makes it difficult to timely collect enough valid cases for statistical analysis. In this paper, we study how to signal potential DDIs using patient electronic health data. Specifically, we focus on discovery of potential DDIs by analyzing the temporal relationships between the concurrent use of two drugs of interest and the occurrences of various symptoms using novel temporal association mining techniques we developed. A new interestingness measure called functional temporal interest was proposed to assess the degrees of temporal association between two drugs of interest and each symptom. The measure was employed to screen potential DDIs from 21,405 electronic patient cases retrieved from the Veterans Affairs Medical Center in Detroit, Michigan. The preliminary results indicate the usefulness of our method in finding potential DDIs for further analysis (e.g., epidemiology study) and investigation (e.g., case review) by drug safety professionals.

  3. 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.

  4. [Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

    Science.gov (United States)

    Wang, Gui-Qian; Gao, Yang; Liu, Fu-Mei; Wei, Rui-Li; Xie, Yan-Ming

    2018-02-01

    To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information. The papers were then screened according to inclusion and exclusion criteria. A total of 234 papers were included in this study, including 164 randomized controlled trials, 7 quasi-randomized controlled trials, 8 non-randomized controls, 56 case series, and 1 cohort study. The patients were only treated with Guizhi Fuling Jiaonang in 56 studies, and Guizhi Fuling Jiaonang was combined with other drugs in 178 studies. The total ADRs/AEs incidence was 1.99% in single use of Guizhi Fuling Jiaonang, and 8.21% in combined use, but showing no severe adverse reactions. Gastrointestinal system damage was most common in mild ADRs. In this study, it was found that the overall safety of Guizhi Fuling Jiaonang was acceptable. The direct evidences of the drug's safety case reports were systematically analyzed in this study, but the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study was not sufficient, so the further studies on the safety of drug use should be conducted in order to provide better guidance for clinical medication. Copyright© by the Chinese Pharmaceutical Association.

  5. [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.

  6. A post-marketing study of gadodiamide hydrate in patients with cerebral infarction

    International Nuclear Information System (INIS)

    Ono, Yuko; Aoki, Shigeki

    2003-01-01

    We evaluated the efficacy and safety of gadodiamide hydrate (GH: Omuniscan) in patients with cerebral infarction in a multicenter post-marketing study. A total of 122 patients enrolled in this study at 16 institutions in throughout Japan. We administrated GH to patients intravenously at 0.2 mL/kg, an approved usage and dosage for head MRI. Efficacy was evaluated by comparing contrast intensity and diagnostic improvement on T1WI before and after the administration of GH and diagnostic significance was investigated. Moreover, clinical data thus obtained were compared with those of phase III studies of GH and other contrast agents with respect to general evaluation of diagnostic improvement. The effects of contrast enhancement on the detection and extent of lesions as well as image quality were judged in terms of improving general evaluation and diagnosis, which was observed in 93.3% of the patients. No serious adverse event were associated with GH administration. The efficacy of GH in this clinical trial was higher, than historical data, with respect to general evaluation and diagnostic improvement. Contrast enhanced MRI with GH in cerebral infarction was confirmed to be of diagnostic value. (author)

  7. 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.

  8. 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.

  9. 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…

  10. 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.…

  11. 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)

  12. 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

  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. Eszopiclone for late-life insomnia

    Directory of Open Access Journals (Sweden)

    Christina S McCrae

    2007-10-01

    Full Text Available Christina S McCrae1, Amanda Ross1, Ashley Stripling2, Natalie D Dautovich21Department of Clinical and Health Psychology, 2Department of Psychology, University of Florida, Gainesville, Florida, USAAbstract: Insomnia, the most common sleep disturbance in later life, affects 20%–50% of older adults. Eszopiclone, a short-acting nonbenzodiazepine hypnotic agent developed for the treatment of insomnia, has been available in Europe since 1992 and in the US since 2005. Although not yet evaluated for transient insomnia in older adults, eszopiclone has been shown to be safe and efficacious for short-term treatment (2 weeks of chronic, primary insomnia in older adults (64–91 years. Clinical studies in younger adults (mean = 44 years have shown eszopiclone can be used for 6–12 months without evidence of problems. Because the oldest participant in these longer-term trials was 69, it not known whether eszopiclone is effective for older adults [particularly the old old (75–84 years and oldest old (85+] when used over longer periods. This is unfortunate, because older individuals frequently suffer from chronic insomnia. Cognitive-behavioral therapy for insomnia, which effectively targets the behavioral factors that maintain chronic insomnia, represents an attractive treatment alternative or adjuvant to eszopiclone for older adults. To date, no studies have compared eszopiclone to other hypnotic medications or to nonpharmacological interventions, such as cognitive-behavioral therapy for insomnia, in older adults. All of the clinical trials reported herein were funded by Sepracor. This paper provides an overview of the literature on eszopiclone with special emphasis on its use for the treatment of late-life insomnia. Specific topics covered include pharmacology, pharmacodynamics, pharmacokinetics, clinical trial data, adverse events, drug interactions, tolerance/dependence, and economics/cost considerations for older adults. Keywords: aging, eszopiclone

  15. Dabigatran Levels in Elderly Patients with Atrial Fibrillation: First Post-Marketing Experiences.

    Science.gov (United States)

    Bolek, Tomáš; Samoš, Matej; Škorňová, Ingrid; Stančiaková, Lucia; Staško, Ján; Galajda, Peter; Kubisz, Peter; Mokáň, Marián

    2018-05-08

    The number of elderly individuals with non-valvular atrial fibrillation (NV-AF) requiring long-term anticoagulation is rising. The pharmacokinetics of oral anticoagulants in elderly individuals may differ from that for younger patients. The aim of this study was to assess the dabigatran levels in elderly patients with NV-AF. A pilot prospective post-marketing study in patients with NV-AF on dabigatran therapy was performed; we enrolled 21 consecutive elderly patients (aged ≥ 75 years) on a reduced dabigatran regimen (110 mg twice daily) and compared them with 13 younger (≤ 70 years) individuals on reduced dabigatran therapy due to renal impairment and with 16 younger patients on standard dabigatran therapy (150 mg twice daily). Blood samples were taken for the assessment of dabigatran trough and peak levels. Dabigatran levels were measured with the Hemoclot ® Thrombin Inhibitor Assay. There were significant differences in dabigatran trough levels when comparing elderly patients on reduced dabigatran with non-elderly patients on reduced dabigatran (99.3 ± 73.6 vs 51.6 ± 25.6 ng/mL; p Similarly, the detected dabigatran peak levels were significantly higher in elderly patients on reduced dabigatran compared with non-elderly patients on reduced dabigatran (173.4 ± 116.2 vs 116.1 ± 19.1 ng/mL; p similar levels compared with younger individuals on standard dabigatran.

  16. 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.

  17. 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.

  18. 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.

    2016-01-01

    Study Objectives: 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. Methods: 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. Results: 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. Citation: Kalmbach DA, Pillai V, Arnedt JT, Drake CL. Identifying at-risk individuals for insomnia using the ford insomnia response to stress test. SLEEP 2016;39(2):449–456. PMID:26446111

  19. 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

  20. [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.

  1. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--II. Gram-negative bacteria].

    Science.gov (United States)

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, carbapenems, monobactams, and penicillins. Changes in CZOP susceptibility among bacteria were also evaluated with the bacterial resistance ratio calculated from the breakpoint MIC. Twenty-five species (4,154 strains) of Gram-negative bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of Moraxella (Branhamella) catarrhalis, Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae, Enterobacter aerogenes, Serratia marcescens, Serratia liquefaciens, Citrobacter freundii, Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas putida, Acinetobacter baumannii, Acinetobacter Iwoffii, Burkholderia cepacia, Stenotrophomonas maltophilia, Bacteroides fragilis group, and Prevotella/Porphyromonas. CZOP preserved its antibacterial activity against M. (B.) catarrhalis (MIC90: 4 micrograms/mL) and showed comparable activity to carbapenems against H. influenzae (MIC90: 1 microgram/mL). The antibacterial activity of CZOP against E. coli was preferable (MIC90: 0.125 microgram/mL) and comparable to those of cefpirome (CPR), cefepime (CFPM), and imipenem (IPM). The MIC90 of CZOP against K. pneumoniae and K. oxytoca was 1 and 0.25 microgram/mL, respectively. The MIC90 of CZOP against E. cloacae increased during 6 years (32 to 128 micrograms/mL). The antibacterial activity of CZOP against E. aerogenes was preferable (MIC90: 1 microgram/mL). The antibacterial activities of CZOP against S. marcescens and S. liquefaciens were relatively potent (MIC90: 0.5 and 0.25 microgram/mL) and comparable to those of CPR, CFPM, and carumonam. CZOP preserved comparable antibacterial

  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

    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.)

  4. 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.

  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. A post-marketing safety and efficacy assessment of a monoclonal antibody purified high-purity factor VIII concentrate.

    Science.gov (United States)

    Hay, C R; Lee, C A; Savidge, G

    1996-01-01

    The identification of infrequent side-effects of clotting factor concentrates, undetected by clinical trials, is facilitated by post-marketing surveillance. We present a post-marketing surveillance study in which 97 patients with haemophilia A, attending three haemophilia centres, were treated over a median follow-up period of 284 days (range 1-1074), and a total follow-up period of 30,080 days, with a pasteurized immunoaffinity purified factor VIII concentrate (Monoclate-P, Armour, Collegeville, USA). 5216 infusions, using 10,527,000 units of Monoclate-P, were carried out, mostly for routine haemarthroses or prophylaxis. No new inhibitors were observed during the study. At the start of the study 60/97 were HIV seropositive, 67/97 HBs antibody positive, 12 HbsAb negative and the remainder HBsAb positive before the study period. 13/14 tested were HAV seropositive at the beginning of the study. One patient became HAV seropositive during the study period, an infection thought to be community acquired. No other seroconversions were observed. Only one mild transfusion reaction was observed. This study confirms the safety and efficacy of Monoclate-P. Post-marketing surveillance or nationally organized pharmaco-vigilance should be practiced more widely to enable identification of low-frequency side-effects of treatment.

  7. [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.

  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. 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.

  10. 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

  11. [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.

  12. 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.

  13. Insomnia

    Science.gov (United States)

    ... a warm bath, reading or listening to soft music. By Mayo Clinic Staff . Mayo Clinic Footer Legal Conditions and Terms Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Terms and Conditions Privacy Policy Notice ...

  14. Insomnia

    Science.gov (United States)

    ... Updated by: Fred K. Berger, MD, addiction and forensic psychiatrist, Scripps Memorial Hospital, La Jolla, CA. Also ... urac.org). URAC's accreditation program is an independent audit to verify that A.D.A.M. follows ...

  15. Insomnia

    Science.gov (United States)

    ... They include: Emotional conditions – depression, anxiety, and posttraumatic stress disorder Neurological disorders – Alzheimer’s or Parkinson’s disease Pain conditions – arthritis and headache disorders Gastrointestinal disorders – heartburn, GERD Sleep disorders – restless ...

  16. Insomnia

    Science.gov (United States)

    ... federal government website managed by the Office on Women's Health in the Office of the Assistant Secretary for Health at the U.S. Department of Health and Human Services . 200 Independence Avenue, S.W., Washington, DC 20201 1-800-994- ...

  17. 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

  18. 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.

  19. 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

    2012-01-01

    Study Objectives: To examine concurrent associations between maternal insomnia and different aspects of the family socialization environment. Design: Mothers reported on their symptoms of insomnia in a private standardized interview and interviewers evaluated the family socialization environment using the Coder's Inventory. Setting: Assessments were conducted in participants' homes within the U.K. Patients or Participants: 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. Interventions: N/A. Measurements and Results: 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 Ambler A; Arseneault L; Houts RM; Caspi A. Maternal insomnia and children's family socialization environments. SLEEP 2012;35(4):579-582. PMID:22467996

  20. Clinical Experience in TCM Treatment of Insomnia

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ Insomnia is a sleeping disorder that affects 1 in 10 Americans and around 50% of the seniors. It is often more prevalent in women. Since September 11, 2005 these estimations have increased. Insomnia can affect not only your energy level and mood, but your health as well because sleep helps bolster your immune system. Insomnia is characterized by: 1) difficulty in falling asleep; 2) waking up frequently during the night with difficulty of returning to sleep; 3) waking up too early in the morning; and 4) with unrefreshing sleep, the patient has a low spirit, palpation, poor memory, viscera function disorder. All these seriously affect the patient's life and work. The following is an account of the authors' clinical TCM experience in treating insomnia.

  1. Clinical practice guidelines for insomnia disorder

    African Journals Online (AJOL)

    Keywords: insomnia, benzodiazepines, cognitive behavioural therapy, sleep wake cycle, pharmacologic treatment .... events which occur just before bedtime, such as physical activity, food and .... benzodiazepines in women and in geriatrics.

  2. Clinical management of behavioral insomnia of childhood

    Directory of Open Access Journals (Sweden)

    Vriend J

    2011-06-01

    Full Text Available Jennifer Vriend1, Penny Corkum21Clinical Psychology PhD Program, Dalhousie University, Halifax, Nova Scotia, Canada; 2Department of Psychology, Dalhousie University, Halifax, Nova Scotia, CanadaAbstract: Behavioral insomnia is highly prevalent, affecting approximately 25% of children. It involves difficulties initiating and maintaining sleep and frequently results in inadequate sleep, leading to an array of negative effects for both the child and the child’s family. In this paper, we describe a variety of empirically supported behavioral interventions for insomnia from infancy through adolescence. We explore how biological, cognitive, and psychosocial developmental changes contribute to behavioral insomnia and how these changes may affect sleep and behavioral interventions. We also discuss barriers that prevent families from accessing interventions, including why many empirically-supported behavioral interventions are overlooked by health care providers.Keywords: sleep, behavioral insomnia, treatment, infants, children, adolescents

  3. 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

  4. Neurobiology of insomnia as measured with FMRI

    OpenAIRE

    Orff, Henry John

    2010-01-01

    Insomnia, the most common sleep disorder afflicting adults, is diagnostically characterized by a chronic complaint of difficulty sleeping at night and a report of consequent impairment in daytime functioning. Despite this diagnostic requirement and the relative prevalence of daytime distress in patients with insomnia, studies to date have shown only limited evidence of objective daytime impairment in this population. This investigation tested a neurobiological compensation model which attempt...

  5. [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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. [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.

  12. [Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

    Science.gov (United States)

    Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

    2014-09-01

    Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

  13. 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

  14. 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

    2011-09-01

    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). Cross-sectional telephone survey. National sample of 7,428 employed health plan subscribers (ages 18+). None. 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 (χ² (1) = 39.5, P absenteeism (χ² (1) = 3.2, P = 0.07), with an annualized individual-level association of 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. 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.

  15. 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

  16. Hubungan Derajat Insomnia Dengan Konsentrasi Belajar Mahasiswa Program Studi Ilmu Keperawatan Di YOGYAKARTA (Correlation Between Insomnia with Learning Concentration Among Nursing Students in YOGYAKARTA)

    OpenAIRE

    Waliyanti, Ema; Pratiwi, Wisni

    2017-01-01

    Intisari Insomnia merupakan salah satu gangguan tidur yang dapat disebabkan oleh stres, masalah sekolah maupun pekerjaan, kesehatan, merokok, ataupun efek samping dari pengobatan. Insomnia berdampak pada kualitas hidup seseorang seperti penurunan konsentrasi. Berdasarkan Statistic by Country for Insomnia terdapat 10% kejadian insomnia yang ada di Indonesia. Penelitian ini bertujuan untuk mengetahui hubungan antara derajat insomnia dengan konsentrasi belajar pada mahasiswa keperawatan di Yogya...

  17. 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 ...

  18. 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...

  19. ‘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...

  20. Cognitive behavioral program in treating insomnia among elderly patients

    OpenAIRE

    Richter, Kneginja; Miloseva, Lence; Niklewski, Günter; Piehl, Anja

    2015-01-01

    Introduction: Insomnia is a most common in elderly patients. World wide experience showed that Cognitive behavioral program in treating insomnia is one of the best effective model. Objectives: The present study aim to present clinical experience from University Clinic Nuremberg, Centre for Sleeping Medicine with application of Cognitive behavioral program in treating insomnia among elderly. Material and Methods: The sample consists of 22 patients with chronic insomnia (10 primary insom...

  1. 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...

  2. 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 ...

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

    African Journals Online (AJOL)

    Insomnia disorder is defined as difficulty in falling asleep, maintaining sleep, and early morning awakenings. Common daytime consequences experienced are fatigue, mood instability and impaired concentration. In chronic insomnia these symptoms persist over a period of at least three months. Chronic insomnia can also ...

  4. 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…

  5. Significance of perfectionism in understanding different forms of insomnia

    OpenAIRE

    Totić-Poznanović Sanja; Šaula-Marojević Biljana; Zebić Mirjana

    2012-01-01

    Introduction. Studies consistently show a connection between perfectionism as a multidimensional construct with various psychological and psychopathological states and characteristics. However, studies that analyze the connection between this concept and sleep disturbances, especially modalities of insomnia, are rare. Objective. The aim of this study was to examine whether dimensions of perfectionism can explain different forms of insomnia; difficulties initiating sleep (insomnia early)...

  6. Static magnetotherapy for the treatment of insomnia.

    Science.gov (United States)

    Shieh, Yao Y; Tsai, Fong Y

    2008-01-01

    Magnets have been used for centuries to treat a number of physical disorders. The vast majority of research, however, on static magnet therapy for insomnia has been confined to the auricular type of therapy, with publications limited to Chinese journals. Most of these studies have depended on the subjective self-assessment of participants rather than objective scientific measurements. In this study, the authors report the positive preliminary results of insomnia treatment using pillows with embedded magnets, magnetic insoles and TriPhase bracelets. The analysis is based on objective actigraphic and polysomnographic data. A theory of accelerated transition from wakefulness to sleep is proposed to explain the process of insomnia relief through low-strength static magnetic fields. Analysis by functional Magnetic Resonance Imaging (fMRI) is used to further investigate the theory.

  7. 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 absenteeism (χ21 = 3.2, P = 0.07), with an annualized individual-level association of 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

  8. 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.

  9. An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada.

    Science.gov (United States)

    Komparic, Ana; Smith, Maxwell J; Thompson, Alison

    2016-04-01

    Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public's health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a 'public health notion of post-market effectiveness', which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine's effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense.

  10. 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.

  11. 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.

  12. Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

    Science.gov (United States)

    Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

    2017-08-01

    Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

  13. 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

  14. Study of insomnia in rotating shift-workers

    Directory of Open Access Journals (Sweden)

    Kaushik Chatterjee

    2017-01-01

    Full Text Available Background: Shift-workers commonly suffer from insomnia. This study evaluates different domains of insomnia. Aim: This study was aimed to study sleep and insomnia in rotating shift-workers and compare with day-workers. Materials and Methods: This was case–control study. The sleep of rotating shift-workers is compared with day workers using Athens Insomnia Scale. Results: Rotating shift-workers had significantly higher scores on Athens insomnia scale on domains of initial, intermediate and terminal insomnia than day workers. Duration and quality of sleep and sense of well-being are lower in rotating shift-workers. Rotating shift-workers also experienced more day-time sleepiness than day workers. However, there was no difference in perceived physical and mental functioning between the two groups. Conclusion: Individuals working in rotating shifts for more than 15 days have significantly higher prevalence of insomnia than day-workers.

  15. Results of a customer-based, post-market surveillance survey of the HeRO access device.

    Science.gov (United States)

    Fusselman, Maureen

    2010-08-01

    In order to supplement post-market surveillance data on the HeRO vascular access device, a non-scientific customer survey was conducted to obtain quantitative data from dialysis providers caring for patients implanted with the device. Dialysis nurses involved in the care of HeRO patients were contacted in order to obtain post-implant device performance information for 10% of patients implanted with the device at the time of the survey. Thirty-eight dialysis units with a total of 65 HeRO patients participated in the survey. The total duration of HeRO device use was 348.4 months with an average use of 5.4 months. Thirty-eight of the 65 HeRO patients (58.5%) were reported to not have experienced any performance issues. There were 28 device performance incidents reported for the remaining 27 patients included in the survey. Occlusion was the single most commonly reported device-related performance issue with 18 patients (27.7%) experiencing 25 occlusive episodes. The majority of the patients who had an occlusion (66.7%) only experienced one occlusive event. Infections occurred in 4 patients (6.2%) with an overall infection rate of 0.38 per 1,000 patient days. Post-market clinical experience during the first 18 months of commercialization of the HeRO device were in line with expectations based on the results from initial clinical studies with the device. Device occlusion remains the most commonly reported performance issue with the reported rate in this survey less than that which was reported in earlier published studies with the device.

  16. Significance of perfectionism in understanding different forms of insomnia

    Directory of Open Access Journals (Sweden)

    Totić-Poznanović Sanja

    2012-01-01

    Full Text Available Introduction. Studies consistently show a connection between perfectionism as a multidimensional construct with various psychological and psychopathological states and characteristics. However, studies that analyze the connection between this concept and sleep disturbances, especially modalities of insomnia, are rare. Objective. The aim of this study was to examine whether dimensions of perfectionism can explain different forms of insomnia; difficulties initiating sleep (insomnia early, difficulties during the sleep (insomnia middle, waking in early hours of the morning (insomnia late and dissatisfaction with sleep quality (subjective insomnia. Methods. The sample consisted of 254 students of the School of Medicine in Belgrade. Predictive significance of nine perfectionism dimensions, measured by Frost’s and Hewitt’s and Flett’s scales of multi-dimensional perfectionism, related to four modalities of insomnia, measured by a structured questionnaire, was analyzed by multiple linear regression method. Results. Perfectionism dimensions are significant predictors of each of the tested forms of insomnia. Doubt about actions significantly predicts initial insomnia; to other-oriented perfectionism in the negative pole and socially prescribed perfectionism underlie the difficulties during the sleep, while organization and parental criticism underlie late insomnia. Significant predictors of subjective insomnia are personal standards and organization and to other-oriented perfectionism on the negative pole. Three of nine analyzed dimensions were not confirmed as significant; concern over mistakes, parental expectations and self-oriented perfectionism. Conclusion. Various aspects of perfectionism can be considered as a vulnerability factor for understanding some forms of insomnia. Out of all forms of insomnia tested, perfectionism as the personality trait proved to be the most significant for understanding subjective insomnia.

  17. Implosive Therapy as a Treatment for Insomnia.

    Science.gov (United States)

    Carrera, Richard N.; Elenewski, Jeffrey J.

    1980-01-01

    The death implosion produced a decrease in insomnia beyond the strong expectancy effects that resulted from all experimental treatments. The failure to observe changes in reported fear of death was attributed to subjects' anxiety-based reluctance to acknowledge openly such fear. (Author)

  18. [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.

  19. 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.

  20. 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

  1. 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

  2. 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.

  3. 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.

  4. Social Support, Insomnia, and Adherence to Cognitive Behavioral Therapy for Insomnia After Cancer Treatment.

    Science.gov (United States)

    Kamen, Charles; Garland, Sheila N; Heckler, Charles E; Peoples, Anita R; Kleckner, Ian R; Cole, Calvin L; Perlis, Michael L; Morrow, Gary R; Mustian, Karen M; Roscoe, Joseph A

    2017-01-27

    While cognitive-behavioral therapy for insomnia (CBT-I) has been shown to be efficacious in treating cancer survivors' insomnia, 30-60% of individuals have difficulty adhering to intervention components. Psychosocial predictors of adherence and response to CBT-I, such as social support, have not been examined in intervention studies for cancer survivors. Data from a randomized placebo-controlled 2 x 2 trial of CBT-I and armodafinil (a wakefulness promoting agent) were used to assess adherence. Ninety-six cancer survivors participated in the trial (mean age 56, 86% female, 68% breast cancer). CBT-I and armodafinil were administered over the course of seven weeks, and participants were assessed at baseline, during intervention, postintervention, and at a three-month follow-up. Social support was assessed using a Functional Assessment of Chronic Illness Therapy subscale, insomnia severity was assessed using the Insomnia Severity Index, and adherence was measured based on CBT-I sleep prescriptions. At baseline, social support was negatively correlated with insomnia severity (r = -0.30, p = 0.002) and associations between social support, CBT-I, and insomnia were maintained through the three-month follow-up. Social support was positively associated with adherence to CBT-I during intervention weeks 3, 4, and 5, and with overall intervention adherence. At postintervention, both social support and treatment with CBT-I independently predicted decreased insomnia severity (p adherence and improved sleep independent of CBT-I. Additional research is needed to determine whether social support can be leveraged to improve adherence and response to CBT-I.

  5. 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

  6. Suvorexant: The first orexin receptor antagonist to treat insomnia

    OpenAIRE

    Dubey, Ashok K.; Handu, Shailendra S.; Mediratta, Pramod K.

    2015-01-01

    Primary insomnia is mainly treated with drugs acting on benzodiazepine receptors and a few other classes of drugs used for different co-morbidities. A novel approach to treat insomnia has been introduced recently, with the approval of suvorexant, the first in a new class of orexin receptor antagonists. Orexin receptors in the brain have been found to play an important role in the regulation of various aspects of arousal and motivation. The drugs commonly used for insomnia therapy to date, hav...

  7. 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 ...

  8. 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.

  9. Adherence to Cognitive Behavioral Therapy for Insomnia: A Systematic Review

    OpenAIRE

    Matthews, Ellyn E.; Arnedt, J. Todd; McCarthy, Michaela S.; Cuddihy, Leisha J.; Aloia, Mark S.

    2013-01-01

    Chronic insomnia is a significant public health problem worldwide, and insomnia has considerable personal and social costs associated with serious health conditions, greater healthcare utilization, work absenteeism, and motor-vehicle accidents. Cognitive Behavioral Therapy for Insomnia (CBTI) is an efficacious treatment, yet attrition and suboptimal adherence may diminish its impact. Despite the increasing use of CBTI, surprisingly little attention has been devoted to understanding the role o...

  10. 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...

  11. 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

  12. Bram Stoker's Dracula : undeath, insomnia and writing

    OpenAIRE

    Rolstad, Lajla

    2006-01-01

    The focus of this thesis is a reading of Bram Stoker’s Dracula. It investigates the experience of horror and the link between horror and desire that can be found in the text. The reading centres on the vampire figure and the vampire’s metaphorical function. Themes like insomnia, undeath, blood, devouring and writing are examined. The reading of Dracula draws on a theoretical framework. In the discussion of horror, Julia Kristeva’s and Emmanuel Levinas’ phenomenological surveys of subjecti...

  13. Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

    Science.gov (United States)

    Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

    2017-11-01

    Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

  14. 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

    2018-05-01

    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.

  15. Risk Management Post-Marketing Surveillance for the Abuse of Medications Acting on the Central Nervous System: Expert Panel Report

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L.; Henningfield, Jack E.; Schuster, Charles R.; Anthony, James C.; Barthwell, Andrea G.; Coleman, John J.; Dart, Richard C.; Gorodetzky, Charles W.; O’Keeffe, Charles; Sellers, Edward M.; Vocci, Frank; Walsh, Sharon L.

    2010-01-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October, 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and eleven recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized. PMID:19783383

  16. [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.

  17. Post-marketing surveillance of the safety and effectiveness of tacrolimus in 3,267 Japanese patients with rheumatoid arthritis.

    Science.gov (United States)

    Takeuchi, Tsutomu; Kawai, Shinichi; Yamamoto, Kazuhiko; Harigai, Masayoshi; Ishida, Kota; Miyasaka, Nobuyuki

    2014-01-01

    A post-marketing surveillance (PMS) program was implemented to assess the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis (RA) patients and to identify risk factors related to adverse drug reactions (ADRs). Patients were registered centrally and monitored for all adverse events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity Score 28-CRP (DAS28-CRP). Data from 3,172 patients (mean age 62.2 years) were evaluated in the safety analysis. Of the safety population, 78.5 %were female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was prescribed as monotherapy in 52.5 % and the most common concomitant disease modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category was infections and infestations. Age ≥ 65 years, concurrent renal dysfunction, and concurrent diabetes mellitus were identified as significant risk factors for ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or good response. The results demonstrate that TAC is well tolerated by Japanese patients with active RA, including those receiving concomitant methotrexate, in the real world.

  18. Safety and effectiveness of certolizumab pegol in patients with rheumatoid arthritis: Interim analysis of post-marketing surveillance.

    Science.gov (United States)

    Kameda, Hideto; Nishida, Keiichiro; Nannki, Toshihiro; Watanabe, Akira; Oshima, Yukiya; Momohara, Shigaki

    2017-01-01

    Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. The total period of exposure to CZP was 1313.8 patient-years (PY). AEs were reported in 658 (25.5%) patients, at an event rate (ER) of 73.68/100 PY. The most frequent serious AEs were pneumonia, herpes zoster, and interstitial lung disease, at ER per 100 PY of 2.06, 1.29, and 1.22, respectively. Mean disease activity scores at baseline, as measured by DAS28-ESR and DAS28-CRP, were 4.77 ± 1.34 and 4.21 ± 1.27, respectively. Mean changes from baseline at the last observation were -1.29 ± 1.46 and -1.30 ± 1.42, respectively. EULAR good or moderate responses were achieved in 65% of patients. Longer disease duration, prior biologics use, and treatment without MTX co-therapy were associated with EULAR no response. In this interim analysis, no new safety signals were observed. Clinical response to CZP was observed in approximately two thirds of patients.

  19. 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.

  20. 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.

  1. 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.

  2. 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...

  3. 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.

  4. Research progress on neural mechanisms of primary insomnia by MRI

    Directory of Open Access Journals (Sweden)

    Man WANG

    2018-04-01

    Full Text Available In recent years, more and more researches focused on the neural mechanism of primary insomnia (PI, especially with the development and application of MRI, and researches of brain structure and function related with primary insomnia were more and more in-depth. According to the hyperarousal hypothesis, there are abnormal structure, function and metabolism under certain brain regions of the cortex and subcortex of primary insomnia patients, including amygdala, hippocampus, cingulate gyrus, insular lobe, frontal lobe and parietal lobe. This paper reviewed the research progress of neural mechanisms of primary insomnia by using MRI. DOI: 10.3969/j.issn.1672-6731.2018.03.003

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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.

  13. 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.

  14. Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

    Science.gov (United States)

    Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

    2011-12-01

    Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

  15. 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

  16. 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.

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

    Science.gov (United States)

    Wang, Can; Shi, Qing-Ping; Ding, Feng; Jiang, Xiao-Dong; Tang, Wei; Yu, Mei-Ling; Zhu, Jian-Hua

    2018-01-01

    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. 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. 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 dose, and indicated vs off-label use. Risk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology

  18. European guideline for the diagnosis and treatment of insomnia

    DEFF Research Database (Denmark)

    Riemann, Dieter; Baglioni, Chiara; Bassetti, Claudio

    2017-01-01

    -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...

  19. Relationships between temperaments, occupational stress, and insomnia among Japanese workers.

    Directory of Open Access Journals (Sweden)

    Yasuhiko Deguchi

    Full Text Available Insomnia among workers reduces the quality of life, contributes toward the economic burden of healthcare costs and losses in work performance. The relationship between occupational stress and insomnia has been reported in previous studies, but there has been little attention to temperament in occupational safety and health research. The aim of this study was to clarify the relationships between temperament, occupational stress, and insomnia. The subjects were 133 Japanese daytime local government employees. Temperament was assessed using the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Auto questionnaire (TEMPS-A. Occupational stress was assessed using the Generic Job Stress Questionnaire (GJSQ. Insomnia was assessed using the Athens Insomnia Scale (AIS. Stepwise multiple logistic regression analyses were conducted. In a stepwise multivariate logistic regression analysis, it was found that the higher subdivided stress group by "role conflict" (OR = 5.29, 95% CI, 1.61-17.32 and anxious temperament score (OR = 1.33; 95% CI, 1.19-1.49 was associated with the presence of insomnia using an adjusted model, whereas other factors were excluded from the model. The study limitations were the sample size and the fact that only Japanese local government employees were surveyed. This study demonstrated the relationships between workers' anxious temperament, role conflict, and insomnia. Recognizing one's own anxious temperament would lead to self-insight, and the recognition of anxious temperament and reduction of role conflict by their supervisors or coworkers would reduce the prevalence of insomnia among workers in the workplace.

  20. Ayurvedic therapy (shirodhara) for insomnia: a case series.

    Science.gov (United States)

    Vinjamury, Sivarama Prasad; Vinjamury, Manjusha; der Martirosian, Claudia; Miller, Judith

    2014-01-01

    Insomnia is one of the most common complaints faced by primary care practitioners after pain. Non-pharmacological management of Insomnia that is noninvasive is gaining interest among patients with insomnia. To determine the feasibility of recruiting and retaining participants in a clinical trial on shirodhara, Ayurvedic oil dripping therapy, for insomnia in the United States and also to investigate the therapeutic usefulness of Shirodhara for insomnia using standardized outcome measures. Case series. Shirodhara with Brahmi oil was done for 45 minutes on each participant for 5 consecutive days. Insomnia Severity Index (ISI) was used to evaluate the severity of insomnia as well as to determine the response to Shirodhara therapy. Data were collected at baseline, end of the treatment (day 5) and 1 week after the treatment ended (follow-up). Two males and eight females with a mean age of 40 years (range 23 to 72), SD ± 14.2, were enrolled in the study. One dropped out of the study, but all remaining nine participants experienced improvement at the end of treatment. The percentage of improvement range varied from 3.85% to 69.57%. At follow-up, most participants continued to improve. Comparison of means between baseline and day 5 indicated an overall significant improvement (P insomnia. It is feasible to recruit and retain participants for such therapies in the United States. It is important to validate these findings and investigate the mechanism of action using a larger sample and rigorous research design.

  1. 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.

  2. Pharmacological Management of Treatment-Induced Insomnia in ADHD

    Science.gov (United States)

    Kratochvil, Christopher J.; Lake, Marybeth; Pliszka, Steven R.; Walkup, John T.

    2005-01-01

    A 7-year-old girl with attention-deficit/hyperactivity disorder (ADHD), combined subtype, and oppositional defiant disorder presents with a complaint of marked insomnia. Her parents describe 60 to 90 minutes of nightly initial insomnia that began with the initiation of 36 mg OROS methylphenidate (Concerta) 2 months ago. Behavioral interventions…

  3. 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

  4. 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.

  5. [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.

  6. 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.

  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. Relationships between temperaments, occupational stress, and insomnia among Japanese workers.

    Science.gov (United States)

    Deguchi, Yasuhiko; Iwasaki, Shinichi; Ishimoto, Hideyuki; Ogawa, Koichiro; Fukuda, Yuichi; Nitta, Tomoko; Mitake, Tomoe; Nogi, Yukako; Inoue, Koki

    2017-01-01

    Insomnia among workers reduces the quality of life, contributes toward the economic burden of healthcare costs and losses in work performance. The relationship between occupational stress and insomnia has been reported in previous studies, but there has been little attention to temperament in occupational safety and health research. The aim of this study was to clarify the relationships between temperament, occupational stress, and insomnia. The subjects were 133 Japanese daytime local government employees. Temperament was assessed using the Temperament Evaluation of Memphis, Pisa, Paris, and San Diego-Auto questionnaire (TEMPS-A). Occupational stress was assessed using the Generic Job Stress Questionnaire (GJSQ). Insomnia was assessed using the Athens Insomnia Scale (AIS). Stepwise multiple logistic regression analyses were conducted. In a stepwise multivariate logistic regression analysis, it was found that the higher subdivided stress group by "role conflict" (OR = 5.29, 95% CI, 1.61-17.32) and anxious temperament score (OR = 1.33; 95% CI, 1.19-1.49) was associated with the presence of insomnia using an adjusted model, whereas other factors were excluded from the model. The study limitations were the sample size and the fact that only Japanese local government employees were surveyed. This study demonstrated the relationships between workers' anxious temperament, role conflict, and insomnia. Recognizing one's own anxious temperament would lead to self-insight, and the recognition of anxious temperament and reduction of role conflict by their supervisors or coworkers would reduce the prevalence of insomnia among workers in the workplace.

  9. [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.

  10. 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.

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

    Science.gov (United States)

    Molen, Yara Fleury; Carvalho, Luciane Bizari Coin; Prado, Lucila Bizari Fernandes do; Prado, Gilmar Fernandes do

    2014-01-01

    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.

  12. 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.

  13. 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.

  14. Sporadic Fatal Insomnia in an Adolescent

    Science.gov (United States)

    Blase, Jennifer L.; Cracco, Laura; Schonberger, Lawrence B.; Maddox, Ryan A.; Cohen, Yvonne; Cali, Ignazio

    2014-01-01

    The occurrence of sporadic prion disease among adolescents is extremely rare. A prion disease was confirmed in an adolescent with disease onset at 13 years of age. Genetic, neuropathologic, and biochemical analyses of the patient’s autopsy brain tissue were consistent with sporadic fatal insomnia, a type of sporadic prion disease. There was no evidence of an environmental source of infection, and this patient represents the youngest documented case of sporadic prion disease. Although rare, a prion disease diagnosis should not be discounted in adolescents exhibiting neurologic signs. Brain tissue testing is necessary for disease confirmation and is particularly beneficial in cases with an unusual clinical presentation. PMID:24488737

  15. 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

  16. 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.

  17. [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

  18. The applicability of animal health surveillance systems for post-market monitoring of potential adverse effects of genetically modified (GM) feed.

    Science.gov (United States)

    Vince, L; Kleter, G A; Kostov, K; Pfeiffer, D U; Guitian, J

    2018-04-20

    A facultative post market monitoring of potential health impacts of genetically modified (GM) feedstuffs on livestock consuming these feeds after pre-market risk assessment is under ongoing consideration. Within the IPAFEED database, scientific studies on health effects beyond performance in livestock and the results of a systematic search for evidence of outcome effects due to GM feed are consolidated. These outcomes were reviewed and checked for consistency in order to identify plausible syndromes suitable for conducting surveillance. The 24 selected studies showed no consistent changes in any health parameter. There were no repeated studies in any species by GM crop type and animal species. As such, there is insufficient evidence to inform the design of surveillance systems for detecting known adverse effects. Animal health surveillance systems have been proposed for the post market monitoring of potential adverse effects in animals. Such systems were evaluated for their applicability to the detection of hypothetical adverse effects and their strengths and weaknesses to detect syndromes of concern are presented. For known adverse effects, applied controlled post-market studies may yield conclusive and high-quality evidence. For detecting unknown adverse effects, the use of existing surveillance systems may still be of interest. A simulation tool developed within the project can be adapted and applied to existing surveillance systems to explore their applicability to the detection of potential adverse effects of GM feed. Copyright © 2018. Published by Elsevier Ltd.

  19. 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

  20. 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

  1. Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

    Science.gov (United States)

    Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

    2017-06-01

    The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

  2. A Post-marketing Surveillance Study of Chronic Wounds Treated With a Native Collagen Calcium Alginate Dressing.

    Science.gov (United States)

    Sabo, Matthew; Le, Lam; Yaakov, Raphael A; Carter, Marissa; Serena, Thomas E

    2018-04-01

    Chronic wounds (ie, wounds that fail to progress through a normal, orderly, timely sequence of repair) continue to pose significant clinical and economic burdens. A prospective, descriptive, 3-week post-marketing surveillance study was conducted across 3 wound care centers in the United States to evaluate the effectiveness of a collagen calcium alginate dressing on chronic wounds in conjunction with standard care (SC) practices (eg, offloading, debridement, compression) to support healing. Eligible participants had to be >18 years of age, have at least 1 chronic wound, and no known sensitivity to collagen. Demographic characteristics were recorded at the screening visit on case report forms. At each visit, wound-related pain was assessed using the Visual Analog Scale along with wound characteristics including size (using digital planimetry), wound exudate (minimal, moderate, heavy), and odor (none, mild). Participants were monitored for adverse events as well as infection based on signs and symptoms in and around the local wound bed, the deeper structures, and the surrounding skin. An intention-to-treat approach was used for all analyses. If an observation was missing, the last observation carried forward principle was used. For wounds that healed, pain and exudate were set to 0 (no pain/exudate) at visit 4. Descriptive, paired t tests and the Wilcoxon signed rank test were used to analyze the data. Of the 31 participants (15 men, 16 women, mean age 66.6 years), most (13, 42%) had a diabetic foot ulcer or venous leg ulcer (10, 32%); median duration of all wounds was 148 days. Thirty (30) patients completed the study. The mean number of comorbidities was 10.6 ± 6.3, and patients used a mean of 9.3 ± 5.64 prescription or over-the-counter medications. For all wounds combined, mean wound area was 4.8 ± 8.38 cm2 at baseline. At week 3, a decrease in wound area of 38.1% was noted (median: 45% ± 42.54; P = .006); 3 wounds healed completely. The change in wound exudate

  3. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

    Directory of Open Access Journals (Sweden)

    Shah K

    2017-05-01

    Full Text Available Kshitij Shah,1 Omvijay B Chaudhari,2 Palash Gupta,3 R Hom Chaudhuri,4 Ranjan Kamilya,5 Shreedhar S Kulkarni,6 S Subbaiah,7 Zubair H Sorathia,8 Gauri Billa9 1MS Orthopedic, Prime Hospital, Andheri (West, 2Vatsalya Nursing Home, Kalyan (West, Mumbai, 3Dr. Palash Gupta Clinic, Rohini, New Delhi, 4Homchaudhuri’s Clinic, 5Apollo Gleneagles Hospital, Kolkata, West Bengal, 6Amrit Clinic, Matunga, Mumbai, 7Subbaiah’s Clinic, West Mambalam, Chennai, 8Medicare Hospital, Marol, Andheri East, 9Medical Services, Abbott Healthcare Pvt. Ltd, Mulund (West, Mumbai, Maharashtra, India Objective: To assess the effectiveness, overall tolerability, and gastrointestinal (GI tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg] in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods: In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at baseline, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results: A total of 351 patients (mean age 44.2 years; male 43%; female 57% were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001. The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as “very good to good”, whereas according to physician’s assessment, “very good to good” tolerability was reported in 68.27% of patients. Five (1.43 % patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients

  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. 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.

  6. [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

  7. New developments in cognitive behavioral therapy as the first-line treatment of insomnia

    OpenAIRE

    Siebern, Allison T; Manber, Rachel

    2011-01-01

    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 grounde...

  8. 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...

  9. 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, ...

  10. 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...

  11. Daytime activity and risk factors for late-life insomnia.

    Science.gov (United States)

    Morgan, Kevin

    2003-09-01

    Laboratory evidence linking exercise with improved sleep quality raises the possibility that the lower levels of physical activity characteristic of older age groups may contribute to late-life insomnia. While support for this hypothesis appears to come from epidemiological surveys, few such studies have distinguished satisfactorily between social and physical activities which differ widely in terms of energy cost and theoretical significance. The present analyses were, therefore, designed to assess the independent influence of physical and social activity levels on the prevalence and natural history of late-life insomnia. Survivors from a nationally representative UK sample (n = 1042) of elderly people originally interviewed in 1985 were reassessed in 1989 (n = 690) and 1993 (n = 410). Detailed assessments of physical and social activities, mental and physical health status, and sleep quality were made at each survey wave. Logistic regression models, adjusted for age, sex and health status, were used to assess relationships between activity levels and the prevalence, remission/persistence, and incidence of late-life insomnia. Lower physical health, depressed mood and lower physical (but not social) activity levels consistently emerged as significant risk factors for prevalent, persistent and incident insomnia. Age was unrelated to insomnia variables in all the cross-sectional models, but did emerge as a significant risk for cumulative 4-8-year insomnia incidence. These findings suggest that, independent of those activities more closely associated with social engagement, higher levels of customary physical activity per se appear to be protective against incident and chronic late-life insomnia.

  12. Quality and readability of online information resources on insomnia

    Institute of Scientific and Technical Information of China (English)

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

    2017-01-01

    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 hospitais 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.

  13. 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.

  14. 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 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

  15. Insomnia, platelet serotonin and platelet monoamine oxidase in chronic alcoholism.

    Science.gov (United States)

    Nenadic Sviglin, Korona; Nedic, Gordana; Nikolac, Matea; Mustapic, Maja; Muck-Seler, Dorotea; Borovecki, Fran; Pivac, Nela

    2011-08-18

    Insomnia is a common sleep disorder frequently occurring in chronic alcoholic patients. Neurobiological basis of insomnia, as well as of alcoholism, is associated with disrupted functions of the main neurotransmitter systems, including the serotonin (5-hydroxytryptamine, 5-HT) system. Blood platelets are considered a limited peripheral model for the central 5-HT neurons, since both platelets and central 5-HT synaptosomes have similar dynamics of 5-HT. Platelet 5-HT concentration and platelet monoamine oxidase type B (MAO-B) are assumed to represent biomarkers for particular symptoms and behaviors in psychiatric disorders. The hypothesis of this study was that platelet 5-HT concentration and platelet MAO-B activity will be altered in chronic alcoholic patients with insomnia compared to comparable values in patients without insomnia. The study included 498 subjects: 395 male and 103 female medication-free patients with alcohol dependence and 502 healthy control subjects: 325 men and 177 women. The effects of early, middle and late insomnia (evaluated using the Hamilton Depression Rating Scale), as well as sex, age and smoking on platelet 5-HT concentration and platelet MAO-B activity were evaluated using one-way ANOVA and multiple regression analysis by the stepwise method. Platelet 5-HT concentration, but not platelet MAO-B activity, was significantly reduced in alcoholic patients with insomnia compared to patients without insomnia. Multiple regression analysis revealed that platelet 5-HT concentration was affected by middle insomnia, smoking and sex, while platelet MAO activity was affected only by sex and age. The present and previous data suggest that platelet 5-HT concentration might be used, after controlling for sex and smoking, as a biomarker for insomnia in alcoholism, PTSD and in rotating shift workers. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  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. Epidemiological, clinical and sleep laboratory evaluations of insomnia

    Science.gov (United States)

    Bixler, E. O.; Kales, A.; Kales, J. D.

    1975-01-01

    Epidemiological studies have contributed to the understanding of the total scope of the insomnia problem, both in terms of the incidence of sleep difficulties, and the extent and frequency of hypnotic drug use. Clinical studies - at the Sleep Research and Treatment Center - have been used to evaluate the medical, psychological, pharmacological and situational factors contributing to insomnia, and to evaluate the psychotherapy and chemotherapy best suited to treatment of insomnia. The sleep laboratory studies were of two types: (1) the study of sleep induction, sleep maintenance, and sleep stages, and (2) the use of hypnotic drugs, emphasizing their effectiveness in inducing and maintaining sleep, and the duration of this effectiveness.

  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. 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.

  20. 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

  1. 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

  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. 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.

  4. 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.

  5. 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...... 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...

  6. MANAGEMENT OF INSOMNIA USING PHARMOCOLOGY OR NON- PHARMACOLOGY

    Directory of Open Access Journals (Sweden)

    Muammar Ghaddafi

    2013-11-01

    Full Text Available Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 Insomnia is a symptom rather than a diagnosis that may lead to irritability, dissatisfaction and decrease individual productivity. Insomnia can be divided into primary and secondary symptom which cause by other condition, but the mechanism on how this happened still unclear. In addition, relation between insomnia and other clinical problem is always undefined because it is impossible to find out the relation between causes and consequences of this symptom. Practitioner can choose either pharmacotherapy or non-pharmacotherapy in management of insomnia patient. Side effects and efficacy of pharmacotherapy must be considered before we prescribe a medicine to de patient. We also can Choose non-pharmacotherapy which is without side effects, but can be same effective as pharmacotherapy and even more.

  7. Sleeping Pills for Insomnia: Which Ones Work Best?

    Science.gov (United States)

    ... Treatment Is Not A Drug Consumer Reports Best Buy Drugs compares the effectiveness and safety of the most ... isn’t a drug at all. CR Best Buy Drugs pick: For chronic insomnia, CR Best Buy Drugs ...

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

    African Journals Online (AJOL)

    emboldens emotional and physical suffering. ... difficulties, with acute discrete episodes of insomnia affecting ... memory, behavioural or mood difficulties, or disturbances in ... Physiological signs of this nocturnal hyper-arousal include.

  9. 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.

  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. 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.

  12. [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.

  13. 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...

  14. 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.

  15. 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.

  16. 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

  17. 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.

  18. Experience in Differentiation and Treatment of Stubborn Insomnia

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    @@Stubborn insomnia is characterized by: a) a long course of illness, lasting over 3 months; b) ineffectiveness of the routine treatment; c) the patient can sleep no more than 2 hours at night; d) the patient has a low spirit, palpitation, poor memory, viscera function disorder, all seriously affecting the patient's life and work. The following is an account of the author's clinical experience in treating stubborn insomnia.

  19. 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

    2014-01-01

    Study Objectives: 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. Design: Longitudinal. Setting: Community-based. Participants: 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). Interventions: None. Measurements and Results: 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. Citation: Drake CL, Pillai V, Roth T. Stress and sleep reactivity: a prospective investigation of the stress-diathesis model of insomnia. SLEEP 2014;37(8):1295-1304. PMID:25083009

  20. 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 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.

  1. 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 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 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.

  2. Insomnia and endothelial function - the HUNT 3 fitness study.

    Directory of Open Access Journals (Sweden)

    Linn B Strand

    Full Text Available BACKGROUND: Insomnia is associated with increased risk of coronary heart disease (CHD, but the underlying mechanisms are not understood. To our knowledge, no previous studies have examined insomnia in relation to endothelial function, an indicator of preclinical atherosclerosis. Our aim was to assess the association of insomnia with endothelial function in a large population based study of healthy individuals. METHODS: A total of 4 739 participants free from known cardiovascular or pulmonary diseases, cancer, and sarcoidosis, and who were not using antihypertensive medication were included in the study. They reported how often they had experienced difficulties falling asleep at night, repeated awakenings during the night, early awakenings without being able to go back to sleep, and daytime sleepiness. Endothelial function was measured by flow mediated dilation (FMD derived from the brachial artery. RESULTS: We found no consistent association between the insomnia symptoms and endothelial function in multiadjusted models, but individual insomnia symptoms may be related to endothelial function. Among women who reported early awakenings, endothelial function may be lower than in women without this symptom (p = 0.03. CONCLUSIONS: This study provided no evidence that endothelial function, an early indicator of atherosclerosis, is an important linking factor between insomnia and CHD. Further studies are needed to explore the complex interrelation between sleep and cardiovascular pathology.

  3. 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.

  4. 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 managing insomnia.

  5. Adolescent insomnia, suicide risk, and the interpersonal theory of suicide.

    Science.gov (United States)

    Zullo, Lucas; Horton, Sarah; Eaddy, Michael; King, Jessica; Hughes, Jennifer; Diederich, Andrew; Kennard, Betsy; Emslie, Graham; Stewart, Sunita

    2017-11-01

    Although insomnia has been repeatedly linked with suicide ideation, the reason for the linkage is not clear. The Interpersonal Psychological Theory of Suicide (IPTS) proposes that three core variables (thwarted belongingness, perceived burdensomeness, and acquired capability) are the final common pathway for all risk factors for suicide ideation and behavior. Recent research has suggested that insomnia may be associated with suicide ideation independently of the IPTS. We examined cross-sectional data from 151 psychiatric inpatients (ages 12-17) to determine if the association between insomnia symptoms and a continuous measure of suicide risk (measured as increasingly severe ideation and plan) was explained by the framework of the IPTS. When all IPTS variables and depressive symptoms were included in the model, insomnia symptoms did not contribute unique variance to suicide risk. Perceived burdensomeness and depressive symptoms were found to explain the relationship between insomnia symptoms and suicide risk. Our findings suggest that improved sleep might reduce suicide risk, that management of interpersonal need cognitions might reduce risk in the presence of insomnia symptoms, and reinforce the independent role of depressive symptoms in suicide risk in clinical samples of adolescents. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. 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.

  7. New Developments in Insomnia Medications of Relevance to Mental Health Disorders.

    Science.gov (United States)

    Krystal, Andrew D

    2015-12-01

    Many insomnia medications with high specificity have become available recently. They provide a window into the clinical effects of modulating specific brain systems and establish a new guiding principal for conceptualizing insomnia medications: "mechanism matters." A new paradigm for insomnia therapy in which specific drugs are selected to target the specific type of sleep difficulty for each patient includes administering specific treatments for patients with insomnia comorbid with particular psychiatric disorders. This article reviews insomnia medications and discusses the implications for optimizing the treatment of insomnia occurring comorbid with psychiatric conditions. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. Paradoxical Insomnia%矛盾性失眠

    Institute of Scientific and Technical Information of China (English)

    谢子珍; 于逢春

    2015-01-01

    失眠是指患者对睡眠时间和/或睡眠质量不满足,且影响日间社会功能的一种主观体验。2014年睡眠障碍国际分类第3版(ICSD-3)将失眠分为慢性失眠、短期失眠及其他类型失眠共三大类,其中矛盾性失眠是慢性睡眠障碍的一个亚型,以主诉夜间睡眠障碍严重与客观检查结果明显不符为主要临床特征。本研究对矛盾性失眠的流行病学、发病机制、辅助检查、临床表现、诊断及治疗进行综述,旨在提高临床医生对该类疾病的认识。%Insomnia refers to patients being not satisfied with sleep time and/or sleep quality,and it is subjective perception which influences patients' daily social function. 2014 International Classification of Sleep Disorders-the Third Edition (ICSD-3)divided insomnia into three diagnostic categories:chronic insomnia disorder,short-term insomnia disorder,and other types of insomnia disorder. Paradoxical insomnia is a subtype of chronic sleep disorder,which has a marked discrepancy between the subjective perception of sleep and objective measurement of sleep. We made a review of the epidemiology, pathogenesis,auxiliary examination,clinical manifestation,diagnosis and treatment of paradoxical insomnia. The study aims to improve the understanding of clinical doctors of this disease.

  15. 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.

  16. 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.

  17. FORTY CASES OF INSOMNIA TREATED WITH ACUPUNCTURE, MASSAGE AND MUSIC THERAPY

    Institute of Scientific and Technical Information of China (English)

    WANG Lin-yu

    2005-01-01

    @@ Insomnia is a commonly encountered sleep disorder in clinical practice. The author of the present paper treated 40 cases of insomnia with acupuncture and massage combined with music therapy and achieved satisfied outcomes. Following is the report.

  18. Therapeutic effects of Jiaotai pill on rat insomnia via regulation of ...

    African Journals Online (AJOL)

    Methods: Rats with PCPA-induced insomnia were divided into 5 groups (n = 10), made up .... carefully excised and stored at -80 °C prior to .... Treatment for Insomnia: A Systematic Review. ... infusion of vigabatrin into the subthalamic nucleus:.

  19. 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.

  20. Prevalence of insomnia in the adult Norwegian population.

    Science.gov (United States)

    Pallesen, S; Nordhus, I H; Nielsen, G H; Havik, O E; Kvale, G; Johnsen, B H; Skjøtskift, S

    2001-11-01

    A representative adult sample (18 years and above) of the Norwegian population, comprising 2001 subjects, participated in telephone interviews, focusing on the one-month point prevalence of insomnia and use of prescribed hypnotics. Employment of DSM-IV inclusion criteria of insomnia yielded a prevalence rate of 11.7%. Logistic regression analysis performed on the different insomnia symptoms revealed that somatic and psychiatric health were the strongest predictors of insomnia, whereas gender, age, and socioeconomic status showed a more inconsistent relationship. Use of prescribed hypnotic drugs was reported by 6.9% and was related to being female, elderly, and having somatic and emotional problems. Sleep onset problems and daytime impairment were more common during winter compared to summer. Use of hypnotics was more common in the southern (rather than the northern) regions of Norway. For sleep onset problems a Season x Region interaction was found, indicating that the prevalence of sleep onset problems increased in southern Norway from summer to winter, while the opposite pattern was found in the northern regions. The importance of clinically adequate criteria and seasonal variation in the evaluation of insomnia is briefly discussed.

  1. [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.

  2. 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.

  3. 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

  4. 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...

  5. 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...

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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 < 0.0001) and -2.71 kg (P < 0.0001), respectively. The present 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.

  12. Safety and effectiveness of gemcitabine in 260 patients with biliary tract cancer in a Japanese clinical practice based on post-marketing surveillance in Japan.

    Science.gov (United States)

    Okubo, Sumiko; Nishiuma, Shinichi; Kobayashi, Noriko; Taketsuna, Masanori; Taniai, Hisashi

    2012-11-01

    Gemcitabine was approved for the treatment of biliary tract cancer in 2006 in Japan. While biliary tract cancer is usually associated with patients 70 years of age or older and/or those who tend to have underlying liver dysfunction, data on this population were limited in the Japanese Phase II study of gemcitabine. Thus, further evaluation of safety and effectiveness in this population was planned. This special post-marketing surveillance was conducted as an observational study on the use of gemcitabine in a clinical practice setting. Gemcitabine-naïve patients with biliary tract cancer were enrolled from 2006 to 2008 and observed over 12 months; one or more doses of gemcitabine were administered during the period. Data such as patient background, treatment details, adverse events occurring during the observational period, laboratory values of liver enzyme and survival status were collected 3 and 12 months after the start of therapy. Of the 285 patients registered for the study, 260 were included in the analysis. The mean age was 66.9 years. There were 120 patients (46.2%) classified as elderly (70 years or older). Haematotoxicities were the most common adverse drug reactions. In the elderly and the non-elderly, adverse drug reactions (serious) occurred in 48.3% (20.8%) and 50.7% (12.9%), respectively. The overall estimated 1-year survival rate was 52.5% (95% confidence interval, 45.9-58.7%). In line with previous clinical and post-marketing studies conducted in Japan, the results of this study suggest that gemcitabine could be used safely and effectively for biliary tract cancer patients including the elderly.

  13. 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

  14. The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.

    Science.gov (United States)

    Tarr, Robert; Hsu, Dan; Kulcsar, Zsolt; Bonvin, Christophe; Rufenacht, Daniel; Alfke, Karsten; Stingele, Robert; Jansen, Olav; Frei, Donald; Bellon, Richard; Madison, Michael; Struffert, Tobias; Dorfler, Arnd; Grunwald, Iris Q; Reith, Wolfgang; Haass, Anton

    2010-12-01

    The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

  15. 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.

  16. 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.

  17. Sporadic fatal insomnia in a young woman: A diagnostic challenge: Case Report

    Directory of Open Access Journals (Sweden)

    Cracco Laura

    2011-10-01

    Full Text Available Abstract Background Sporadic fatal insomnia (sFI and fatal familial insomnia (FFI are rare human prion diseases. Case Presentation We report a case of a 33-year-old female who died of a prion disease for whom the diagnosis of sFI or FFI was not considered clinically. Following death of this patient, an interview with a close family member indicated the patient's illness included a major change in her sleep pattern, corroborating the reported autopsy diagnosis of sFI. Genetic tests identified no prion protein (PrP gene mutation, but neuropathological examination and molecular study showed protease-resistant PrP (PrPres in several brain regions and severe atrophy of the anterior-ventral and medial-dorsal thalamic nuclei similar to that described in FFI. Conclusions In patients with suspected prion disease, a characteristic change in sleep pattern can be an important clinical clue for identifying sFI or FFI; polysomnography (PSG, genetic analysis, and nuclear imaging may aid in diagnosis.

  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. 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....

  20. 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

  1. 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

  2. Acupuncture Treatment of Insomnia-A Report of 28 Cases

    Institute of Scientific and Technical Information of China (English)

    时冬丽

    2003-01-01

    @@ Insomnia, also called hyposomnia, refers to the disorder characterized by failure to obtain a normal sleep. For mild cases, the patients are slow to go into sleep, or in an oneirism or with very short sleep. For severe cases, the patients can only have a sleep of 2 to 3 hours or even no sleep during the night, which inserts a serious impact on the normal life of the patients. Using Shenmen (HT 7) and Benshen (GB 13) as the main points, the author has treated 28 cases of insomnia with quick and satisfactory therapeutic effect. A report follows.

  3. Adapting Cognitive-Behavior Therapy for Insomnia in Cancer Patients

    Directory of Open Access Journals (Sweden)

    Eric S. Zhou

    2017-12-01

    Full Text Available Insomnia disorder is common in patients undergoing cancer treatment. There is compelling evidence demonstrating that cognitive-behavioral therapy for insomnia (CBT-I should be the initial treatment, but there has been insufficient research has been conducted among cancer patients. This population presents with unique physical and psychosocial health issues that may interfere with standard CBT-I and addressing these issues can play a role in improving treatment adherence and efficacy. We explore potential adaptations that can be made to standard CBT-I for cancer patients. Further research for this growing population is essential.

  4. [Susceptibility surveillance of clinical isolates to fluoroquinolone antimicrobial agents from 2003 to 2008: post-marketing study of prulifloxacin].

    Science.gov (United States)

    Kawai, Shin; Yoshida, Atsushi; Okazaki, Mitsuhiro; Tsujihara, Yoshito; Inuzuka, Kazuhisa; Takeuchi, Kazuhide; Yamashita, Naoko; Onodera, Makoto; Hiraishi, Toru; Ida, Takashi; Maebashi, Kazunori

    2010-06-01

    Yearly changes in the susceptibility of clinical isolates to ulifloxacin (UFX) and other fluoroquinolones were examined through surveys over 3 periods. In the first survey, 534 strains derived from 19 species were collected from clinical specimens during 6 months from December 2003 to May 2004. In the same way, 805 strains were collected from December 2005 to May 2006 in the second survey, and 863 strains were from December 2007 to May 2008 in the third survey. Over these 3 study periods, the susceptibilities of fluoroquinolones against methicillin-susceptible Staphylococcus aureus and Escherichia coli were decreased. The isolation frequency of levofloxacin-nonsusceptible strain was increased from 0% to 11.8% and from 14.6% to 20.8%, respectively. MIC90s of UFX against these pathogens were also increased, but its MIC90 for E. coli was 2 to 4 times lower than that of levofloxacin. On the other hand, the susceptibility of strains of Klebsiella pneumoniae to UFX was increased. Among the fluoroquinolones tested, UFX showed the most potent activity against Pseudomonas aeruginosa, and no changes in the MIC90s occurred during the surveillance. Although one strain of Streptococcus pneumoniae isolated in the third study period showed levofloxacin-resistance (MIC, 8 microg/mL), there were nearly no changes in the MIC90s of any agents tested including UFX against S. pneumoniae during the surveillance. As for other bacterial species, a tendency to increase in resistance to UFX was not observed. The activity of UFX against Salmonella spp. and Shigella spp. was superior/equal to those of fluoroquinolones tested.

  5. 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

  6. Adult Attention-Deficit/Hyperactivity Disorder (ADHD) and Insomnia: an Update of the Literature.

    Science.gov (United States)

    Wynchank, Dora; Bijlenga, Denise; Beekman, Aartjan T; Kooij, J J Sandra; Penninx, Brenda W

    2017-10-30

    Insomnia is diagnosed when there is dissatisfaction with sleep quantity or quality. It has a prevalence in the general population ranging from 31 to 56%. Insomnia has previously been associated with adult attention-deficit/hyperactivity disorder (ADHD). In this review, we address three topics: (1) the cross-sectional relationship between ADHD and insomnia in adulthood, (2) the longitudinal relationship between ADHD and insomnia, and (3) insomnia as a side effect of pharmacological treatments for adult ADHD. Three cross-sectional, clinical, and population studies report a prevalence of insomnia in ADHD adults ranging from 43 to 80%. Longitudinal evidence for a link between childhood-onset ADHD and insomnia at later age is mixed, with one study confirming and another study not supporting such a longitudinal association. In randomized, placebo-controlled trials, insomnia is reported significantly more often in the treatment arm than in the placebo arm. In varying percentages of trial participants, insomnia is a treatment-emergent adverse effect in triple-bead mixed amphetamine salts (40-45%), dasotraline (35-45%), lisdexamfetamine (10-19%), and extended-release methylphenidate (11%). Ten to seventeen percent of subjects in placebo-controlled trials of atomoxetine report insomnia, possibly related to poor metabolizer status. The mechanisms explaining the relationship between ADHD and sleep problems are incompletely understood, but both genetic and non-shared environmental influences may be involved. Adults with ADHD should be assessed for insomnia, which is frequently comorbid, and both conditions should be treated.

  7. 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.

  8. 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.

  9. 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 stress-induced cognitive intrusion (OR = 1.61; P stressful events on risk for insomnia (P sleep reactivity significantly increased risk for insomnia (OR = 1.78; P sleep reactivity moderated the effects of stress-induced intrusion (P sleep reactivity. Trait sleep reactivity also constituted a significant risk for depression (OR = 1.67; P sleep reactivity is a significant risk factor for incident 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. Media use and insomnia after terror attacks in France.

    Science.gov (United States)

    Goodwin, Robin; Lemola, Sakari; Ben-Ezra, Menachem

    2018-03-01

    Direct exposure to traumatic events often precipitates sleep disorders. Sleep disturbance has also been observed amongst those indirectly exposed to trauma, via mass media. However, previous work has focused on traditional media use, rather than contemporary social media. We tested associations between both traditional and social media consumption and insomnia symptoms following 2015 terror attacks in Paris France, controlling for location and post-traumatic symptomology. 1878 respondents, selected to represent the national French population, completed an internet survey a month after the Bataclan attacks (response rate 72%). Respondents indicated different media use, post-traumatic stress and insomnia. Controlling for demographics, location and PTSD, insomnia was associated with both traditional (β 0.10, P = .001) and social media use (β 0.12, P = .001). Associations between social media and insomnia were independent of traditional media use. Interventions targeted at social media may be particularly important following mass trauma. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. 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.

  16. 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.

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

    DEFF Research Database (Denmark)

    Mayer, Geert; Jennum, Poul; Riemann, Dieter

    2011-01-01

    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...

  18. 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...

  19. Cognitive-Behavior Therapy for Late-Life Insomnia.

    Science.gov (United States)

    Morin, Charles M.; And Others

    1993-01-01

    Assigned 24 older adults with persistent psychophysiological insomnia to immediate or delayed cognitive-behavioral intervention in waiting-list control group design. Treatment was effective in reducing sleep latency, wake after sleep onset, and early morning awakening, and in increasing sleep efficiency. Sleep improvements obtained by…

  20. 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.

  1. 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.

  2. 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

  3. LECTURES ON ACUPUNCTURE—PartⅠ Clinical Acupuncture Lecture Nineteen INSOMNIA

    Institute of Scientific and Technical Information of China (English)

    XuLi; MengHong; WangShaorong; WangWei

    2000-01-01

    Insomnia refers to a disorder in which patient can not have normal or enough sleep. Clinically, it has different manifestations. In mild cases, it is manifested as difficulty in getting to sleep, easy to wake up and unable to sleep againafter waking. In severe cases, it is manifested as sleeplessness during the whole night.

  4. 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 ...

  5. 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%

  6. Insomnia and Psychosocial Crisis: Two Studies of Erikson's Developmental Theory.

    Science.gov (United States)

    Wagner, Karen Dineen; And Others

    1983-01-01

    Examines the role of internal stressors in the development of sleep disturbances in two studies of 122 older adults and 66 college students. Results confirmed Erikson's (1959) developmental theory. Failure to resolve the psychosocial crises of old age and adolescence were related to insomnia. (WAS)

  7. 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

  8. Deep Learning and Insomnia: Assisting Clinicians With Their Diagnosis.

    Science.gov (United States)

    Shahin, Mostafa; Ahmed, Beena; Hamida, Sana Tmar-Ben; Mulaffer, Fathima Lamana; Glos, Martin; Penzel, Thomas

    2017-11-01

    Effective sleep analysis is hampered by the lack of automated tools catering to disordered sleep patterns and cumbersome monitoring hardware. In this paper, we apply deep learning on a set of 57 EEG features extracted from a maximum of two EEG channels to accurately differentiate between patients with insomnia or controls with no sleep complaints. We investigated two different approaches to achieve this. The first approach used EEG data from the whole sleep recording irrespective of the sleep stage (stage-independent classification), while the second used only EEG data from insomnia-impacted specific sleep stages (stage-dependent classification). We trained and tested our system using both healthy and disordered sleep collected from 41 controls and 42 primary insomnia patients. When compared with manual assessments, an NREM + REM based classifier had an overall discrimination accuracy of 92% and 86% between two groups using both two and one EEG channels, respectively. These results demonstrate that deep learning can be used to assist in the diagnosis of sleep disorders such as insomnia.

  9. 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

  10. A brief tool to differentiate factors contributing to insomnia complaints.

    Science.gov (United States)

    Townsend, Donald; Kazaglis, Louis; Savik, Kay; Smerud, Adam; Iber, Conrad

    2017-03-01

    A complaint of insomnia may have many causes. A brief tool examining contributing factors may be useful for nonsleep specialists. This study describes the development of the Insomnia Symptoms Assessment (ISA) for examining insomnia complaints. ISA questions were designed to identify symptoms that may represent 1 of 8 possible factors contributing to insomnia symptoms, including delayed sleep phase syndrome (DSPS), shift work sleep disorder (SWSD), obstructive sleep apnea (OSA), mental health, chronic pain, restless leg syndrome (RLS), poor sleep hygiene, and psychophysiological insomnia (PI). The ISA was completed by 346 new patients. Patients met with a sleep specialist who determined primary and secondary diagnoses. Mean age was 45 (18-85) years and 51% were male. Exploratory factor analysis (n = 217) and confirmatory factor analysis (n = 129) supported 5 factors with good internal consistency (Cronbach's alpha), including RLS (.72), OSA (.60), SWSD (.67), DSPS (.64), and PI (.80). Thirty percent had 1 sleep diagnosis with a mean of 2.2 diagnoses per patient. No diagnosis was entered for 1.2% of patients. The receiver operating characteristics were examined and the area under the curves calculated as an indication of convergent validity for the primary diagnosis (N = 346) were .97 for SWSD, .78 for OSA, .67 for DSPS, .54 for PI, and .80 for RLS. The ISA demonstrated good internal consistency and corresponds well to expert diagnoses. Next steps include setting sensitivity/specificity cutoffs to suggest initial treatment recommendations for use in other settings. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  11. 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,

  12. [Daytime consequences of insomnia complaints in the French general population].

    Science.gov (United States)

    Ohayon, M M; Lemoine, P

    2004-01-01

    Insomnia is a frequent symptom in the general population; numerous studies have proven this. In the past years, classifications have gradually given more emphasis to daytime repercussions of insomnia and to their consequences on social and cognitive functioning. They are now integrated in the definition of insomnia and are used to quantify its severity. If the daytime consequences of insomnia are well known at the clinical level, there are few epidemiological data on this matter. The aim of this study was to assess the daytime repercussions of insomnia complaints in the general population of France. A representative sample (n=5,622) aged 15 or older was surveyed by telephone with the help of the sleep-EVAL expert system, a computer program specially designed to evaluate sleep disorders and to manage epidemiological investigations. Interviews have been completed for 80.8% of the solicited subjects (n=5,622). The variables considered comprised insomnia and its daytime repercussions on cognitive functioning, affective tone, daytime sleepiness and diurnal fatigue. Insomnia was found in 18.6% of the sample. The prevalence was higher in women (22.4%) than in men (14.5%, psleep. Nearly 75% of insomnia complainers reported having a disrupted sleep or waking up too early in the morning and about 40% said they had a non-restorative sleep. Repercussions on daytime functioning were reported by most insomnia subjects (67%). Repercussions on cognitive functioning changed according age, number of insomnia symptoms and the use of a psychotropic medication. A decreased efficiency was more likely to be reported by subjects between 15 and 44 years of age (OR: 2.9), those using a psychotropic (OR: 1.5), those reporting at least three insomnia symptoms (OR: 1.4) and women (OR: 1.4). The highest probability of the appearance of concentration difficulties was found in subjects younger than 65 Years, having a depressive disorder and using a psychotropic (15-44 years: OR 19.1; 45-64 years

  13. Mechanism of Mongolian medical warm acupuncture in treating insomnia by regulating miR-101a in rats with insomnia.

    Science.gov (United States)

    Bo, Agula; Si, Lengge; Wang, Yuehong; Bao, Lidao; Yuan, Hongwei

    2017-07-01

    MicroRNAs (miRNAs or miRs) and the target genes before and after warm acupuncture at the genetic level were assessed, and the cytokines and neurotransmitters related to insomnia were studied. Male Sprague-Dawley rats were used to create PCPA insomnia rat models and randomly divided into the normal, model, warm acupuncture, and drug groups. The Dinghui Acupoint, Heyi Acupoint, and Xin Acupoint were inserted in the Mongolian medicine warm acupuncture group. The differential expression profile of microRNA in the brain tissue of the insomnia rats was determined before and after Mongolian medicine warm acupuncture for establishment of miR-101a mimics and inhibitor. qPCR was used to detect the expression level of miR-101a. Western blotting was used to detect the expression level of PAX8. The rats receiving Mongolian medicine warm acupuncture had 141 miRNAs with differential expression compared with the normal rats. The expression level of miR-101a in the cells of the hippocampus of the insomnia rats transfected with miR-101a mimics increased significantly at 72 h (Pwarm acupuncture or western medicine treatment (Pwarm acupuncture is directly associated with PAX8 regulation.

  14. 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

  15. ["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

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. Obsessive-compulsive personality disorder features and response to behavioral therapy for insomnia among patients with hypnotic-dependent insomnia.

    Science.gov (United States)

    Petrov, Megan E; Emert, Sarah E; Lichstein, Kenneth L

    2018-06-05

    To compare therapeutic response to behavioral therapy for insomnia (BT-I) among hypnotic-dependent insomnia (HDI) patients with and without Cluster C personality disorders. Twenty-three adults with HDI (17 females), aged between 33 and 68 (M = 53; SD = 9.9) were included in the study. Participants completed a personality disorder assessment (baseline), as well as sleep diaries, polysomnography (PSG), and an insomnia severity assessment (baseline, posttreatment, and one-year follow-up). Treatment consisted of eight weeks of individual BT-I and gradual hypnotic medication withdrawal. Multilevel mixed-effects linear regression models examined the interaction between study visit and Cluster C personality disorders status on treatment response to BT-I. Obsessive-compulsive personality disorder (OCPD) was the most prevalent of the Cluster C personality disorders with 38% (n = 8) of participants meeting criteria. There were no significant treatment differences by OCPD status across time as measured by sleep diaries and insomnia severity status. However, there were significant treatment differences by OCPD status by one-year follow-up on PSG outcomes, indicating that patients with OCPD status had shorter and more disrupted sleep than patients without OCPD status. Based on self-reported sleep measures, patients with insomnia and features of OCPD responded equivalently to BT-I at one-year follow-up compared to patients without features of OCPD. However, polysomnography outcomes indicated objective sleep deteriorated in these patients, which may suggest greater vulnerability to relapse.

  1. 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

  2. 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

  3. Correlates of general quality of life are different in patients with primary insomnia as compared to patients with insomnia and psychiatric comorbidity

    NARCIS (Netherlands)

    van de Laar, M.; Pevernagie, D.A.; van Mierlo, P.; Overeem, S.

    2016-01-01

    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

  4. 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

  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. Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.

    Science.gov (United States)

    Johanson, Chris-Ellyn; Balster, Robert L; Henningfield, Jack E; Schuster, Charles R; Anthony, James C; Barthwell, Andrea G; Coleman, John J; Dart, Richard C; Gorodetzky, Charles W; O'Keeffe, Charles; Sellers, Edward M; Vocci, Frank; Walsh, Sharon L

    2009-12-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.

  7. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

    Science.gov (United States)

    Endrikat, J; Schwenke, C; Prince, M R

    2015-07-01

    To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Are we sleeping on the job? Insomnia among men with prostate cancer

    Directory of Open Access Journals (Sweden)

    Frances Josephine Drummond

    2016-06-01

    Full Text Available Prostate cancer is one of the most commonly diagnosed cancers in men and almost half of male cancer survivors in the US have had a prostate cancer diagnosis. Insomnia is common among cancer patients and survivors. There is evidence that cognitive behavioural therapy can be used to effectively manage insomnia among women with breast cancer. The aim of this review was to investigate the prevalence, risk factors and management of insomnia among men with prostate cancer. The effect of insomnia on the psychological health and health-related quality of life of these patients and/or survivors is also discussed. Increased awareness and knowledge of this symptom among men with prostate cancer may facilitate improved diagnosis, and management of insomnia in this large population. This in turn may improve the health-related quality of life of these men. Therefore, research into the effective management of insomnia among men with prostate cancer is essential.

  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. 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.

  15. Insomnia in places of detention: a review of the most recent research findings

    OpenAIRE

    Elger, Bernice Simone

    2007-01-01

    Up to 40% of prisoner patients in a general medicine outpatient service seek medical consultation for sleep problems. This paper provides a brief overview of what is known about insomnia and its treatment from studies on non-detained patients and discusses the relevance of the findings from studies in liberty for prison health care. The clinical and ethical issues of insomnia in prison are described, followed by a summary of the existing studies on insomnia in prison. The results of the repor...

  16. 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.

  17. 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

  18. Individual, lifestyle, and psychosocial factors related to insomnia among Norwegian musicians

    OpenAIRE

    Saksvik-Lehouillier, Ingvild; Bjerkeset, Ottar; Vaag, Jonas

    2017-01-01

    Musicians report a considerably higher prevalence of insomnia symptoms compared to community samples in the general workforce. The aim of this study was to investigate the association between insomnia and health, work-related, and lifestyle factors among musicians. A total of 645 full-time musicians completed a questionnaire measuring insomnia symptoms: personality, psychosocial factors (perceived job demands, job control, effort-reward imbalance, and general social support), and lifestyle (s...

  19. Familial Risk for Insomnia Is Associated With Abnormal Cortisol Response to Stress.

    Science.gov (United States)

    Drake, Christopher L; Cheng, Philip; Almeida, David M; Roth, Thomas

    2017-10-01

    Abnormalities in the stress system have been implicated in insomnia. However, studies examining physiological stress regulation in insomnia have not consistently detected differences in the hypothalamic-pituitary-adrenal (HPA)-axis response to stress. One explanation may be that deficits in the stress system are associated specifically with a biological vulnerability to insomnia rather than the phenotypic expression of insomnia. To examine stress response as a function of vulnerability to insomnia, this study tested response to the Trier Social Stress Test in a sample of healthy sleepers with varying familial risks for insomnia. Thirty-five healthy individuals with and without familial risk for insomnia were recruited to complete a laboratory stressor. Participants with one or both biological parents with insomnia were categorized as positive for familial risk, whereas those without biological parents with insomnia were categorized as negative for familial risk. Participants completed the Trier Social Stress Test in the laboratory, and psychological and physiological (autonomic and HPA-axis) responses were compared. Despite self-reported increases in anxiety, those positive for familial risk exhibited a blunted cortisol response relative to those without familial risk for insomnia. Individuals with blunted cortisol also reported heightened reactivity to personal life stressors, including increased sleep disturbances, elevated cognitive intrusions, and more behavioral avoidance. Findings from this study provide initial evidence that abnormal stress regulation may be a biological predisposing factor conferred via familial risk for insomnia. This deficit may also predict negative consequences over time, including insomnia and the associated psychiatric comorbidities. © 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.

  20. 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)...

  1. 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...

  2. 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...

  3. 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.

  4. 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.

  5. Characteristics of napping in community-dwelling insomnia patients.

    Science.gov (United States)

    Jang, Kwang Ho; Lee, Jung Hie; Kim, Seong Jae; Kwon, Hyo Jeong

    2018-05-01

    We aimed to determine napping characteristics of community-dwelling patients with insomnia disorder (ID) compared to characteristics of normal controls (NC), and to examine the effect of napping on nocturnal sleep. Adult volunteers who were more than 18 years old were recruited from three rural public health centers in Korea. Data from actigraphy recording and a sleep diary filled out for seven days were obtained. Finally, 115 ID patients and 80 NC subjects were included in this study. Parameters and timing of nocturnal sleep and nap were compared between the ID and NC groups. Two-way analysis of covariance (ANCOVA) was performed to determine the effect of ID diagnosis and napping on sleep parameters. Sleep efficiency (SE) in the ID group was significantly lower (p = 0.010), and wake time after sleep onset (WASO) was significantly greater (p = 0.023), compared to the NC group. There was no significant difference in nocturnal sleep or nap timing between the two groups. Nap frequency in the ID group was significantly higher than that in the NC group (p = 0.025). Although ID diagnosis and napping had no independent effect on fragmentation index, their interaction had a significant effect on fragmentation index (p = 0.021). Nap frequency was positively correlated with PSQI score (r = 0.166, p = 0.033). Insomnia patients showed no significant difference in nap timing or nap duration compared to NC subjects. However, insomnia patients showed higher nap frequency. Frequent napping was associated with poorer subjective sleep quality. Therefore, although napping might not have a negative impact on nocturnal sleep maintenance in NC subjects, it did have an effect on nocturnal sleep in insomnia patients. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. 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...

  7. 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 ...

  8. 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...

  9. 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

  10. 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.

  11. 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.

    2016-01-01

    Objectives 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. Methods A longitudinal study with three annual assessments. The community-based sample included 262 adults with no history of insomnia or depression who developed insomnia 1 year after baseline (67.6% female; 44.0±13.4y). 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. Results Sensitization of the sleep system was observed from baseline to insomnia onset at 1-y follow-up among insomniacs with low premorbid vulnerability (pinsomnia remission (pinsomnia onset. The impact of sensitization on depression was stable at 2-y follow-up (p=.01). Conclusions Evidence supports sensitization of the sleep system as 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. PMID:27448474

  12. 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.

  13. 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.

  14. 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.

  15. INSOMNIA DAN DIAGNOSIS PSIKIATRI PADA PASIEN DI INSTALASI RAWAT DARURAT (IRD RSUP SANGLAH

    Directory of Open Access Journals (Sweden)

    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%.

  16. 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.

  17. Effects of Cognitive Behavioral Therapy for Insomnia on Suicidal Ideation in Veterans

    Science.gov (United States)

    Trockel, Mickey; Karlin, Bradley E.; Taylor, C. Barr; Brown, Gregory K.; Manber, Rachel

    2015-01-01

    Objective: To examine the effects of cognitive behavioral therapy for insomnia (CBT-I) on suicidal ideation among Veterans with insomnia. Design: Longitudinal data collected in the course of an uncontrolled evaluation of a large-scale CBT-I training program. Setting: Outpatient and residential treatment facilities. Participants: Four hundred five Veterans presenting for treatment of insomnia. Interventions: Cognitive behavioral therapy for insomnia. Measurement and Results: At baseline, 32% of patients, compared with 21% at final assessment, endorsed some level of suicidal ideation [χ2(df = 1) = 125; P suicidal ideation. The effect of change in insomnia severity on change in depression severity was also significant. After controlling for change in depression severity and other variables in the model, the effect of change in insomnia severity on change in suicidal ideation remained significant. Conclusion: This evaluation of the largest dissemination of cognitive behavioral therapy for insomnia (CBT-I) in the United States found a clinically meaningful reduction in suicidal ideation among Veterans receiving CBT-I. The mechanisms by which effective treatment of insomnia with CBT-I reduces suicide risk are unknown and warrant investigation. The current results may have significant public health implications for preventing suicide among Veterans. Citation: Trockel M, Karlin BE, Taylor CB, Brown GK, Manber R. Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans. SLEEP 2015;38(2):259–265. PMID:25515115

  18. Efficacy and Tolerability of Indiplon in Transient Insomnia

    Science.gov (United States)

    Rosenberg, Russell; Roth, Thomas; Scharf, Martin B.; Lankford, D. Alan; Farber, Robert

    2007-01-01

    Objectives: The efficacy of indiplon was evaluated by polysomnography (PSG) in an experimental model of transient insomnia consisting of the first night effect combined with a 2-hour phase advance. Methods: Healthy volunteers age 21–64 years (N=593; 62% female; mean (± SEM) years, 32±0.39) were randomized to double-blind treatment with a single nighttime dose of indiplon (10 mg or 20 mg) or placebo. PSG assessments included latency to persistent sleep (LPS, primary endpoint) and total sleep time (TST); self-report assessments included sleep quality (SQ); next day residual effects were evaluated by the Digit Symbol Substitution Test (DSST), Symbol Copying Test (SCT), and a Visual Analog Scale of sleepiness (VAS). Results: LPS mean (± SEM) values were significantly reduced on indiplon 10 mg (21.2±1.5 minutes) and indiplon 20 mg (16.8±1.1 minutes) compared to placebo (33.1±2.5minutes; p inducing sleep, increasing sleep duration, and improving overall sleep quality without next day residual effects in healthy volunteers in a model of transient insomnia. Citation: Rosenberg R; Roth T; Scharf MB et al. Efficacy and tolerability of indiplon in transient insomnia. J Clin Sleep Med 2007;3(4):374-379. PMID:17694726

  19. 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.

  20. 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.

  1. Singular spectrum analysis of sleep EEG in insomnia.

    Science.gov (United States)

    Aydın, Serap; Saraoǧlu, Hamdi Melih; Kara, Sadık

    2011-08-01

    In the present study, the Singular Spectrum Analysis (SSA) is applied to sleep EEG segments collected from healthy volunteers and patients diagnosed by either psycho physiological insomnia or paradoxical insomnia. Then, the resulting singular spectra computed for both C3 and C4 recordings are assigned as the features to the Artificial Neural Network (ANN) architectures for EEG classification in diagnose. In tests, singular spectrum of particular sleep stages such as awake, REM, stage1 and stage2, are considered. Three clinical groups are successfully classified by using one hidden layer ANN architecture with respect to their singular spectra. The results show that the SSA can be applied to sleep EEG series to support the clinical findings in insomnia if ten trials are available for the specific sleep stages. In conclusion, the SSA can detect the oscillatory variations on sleep EEG. Therefore, different sleep stages meet different singular spectra. In addition, different healthy conditions generate different singular spectra for each sleep stage. In summary, the SSA can be proposed for EEG discrimination to support the clinical findings for psycho-psychological disorders.

  2. Adherence to cognitive behavioral therapy for insomnia: a systematic review.

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    Matthews, Ellyn E; Arnedt, J Todd; McCarthy, Michaela S; Cuddihy, Leisha J; Aloia, Mark S

    2013-12-01

    Chronic insomnia is a significant public health problem worldwide, and insomnia has considerable personal and social costs associated with serious health conditions, greater healthcare utilization, work absenteeism, and motor-vehicle accidents. Cognitive behavioral therapy for insomnia (CBTI) is an efficacious treatment, yet attrition and suboptimal adherence may diminish its impact. Despite the increasing use of CBTI, surprisingly little attention has been devoted to understanding the role of adherence. This review describes a comprehensive literature search of adherence to CBTI. The search revealed 15 studies that evaluated adherence to CBTI in adults using valid and reliable measures of sleep, and measure of adherence other than study withdrawals. The primary purposes of this review were to 1) synthesize current study characteristics, methodology, adherence rates, contributing factors, and impact on outcomes, 2) discuss measurement issues, and 3) identify future practice and research directions that may lead to improved outcomes. Strong patterns and inconsistencies were identified among the studies, which complicate an evaluation of the role of adherence as a factor and outcome of CBTI success. The importance of standardized adherence and outcome measures is discussed. In light of the importance of adherence to behavior change, this systematic review may better inform future intervention efforts. Copyright © 2013 Elsevier Ltd. All rights reserved.

  3. Pharmacotherapy of Insomnia with Ramelteon: Safety, Efficacy and Clinical Applications

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    Seithikurippu R. Pandi-Perumal

    2011-01-01

    Full Text Available Ramelteon is a tricyclic synthetic analog of melatonin that acts specifically on MT 1 and MT 2 melatonin receptors. Ramelteon is the first melatonin receptor agonist approved by the Food and Drug Administration (FDA for the treatment of insomnia characterized by sleep onset difficulties. Ramelteon is both a chronobiotic and a hypnotic that has been shown to promote sleep initiation and maintenance in various preclinical and in clinical trials. The efficacy and safety of ramelteon in patients with chronic insomnia was initially confirmed in short-term placebo-controlled trials. These showed little evidence of next-day residual effects, withdrawal symptoms or rebound insomnia. Other studies indicated that ramelteon lacked abuse potential and had a minimal risk of producing dependence or adverse effects on cognitive or psychomotor performance. A 6-month placebo-controlled international study and a 1-year open-label study in the USA demonstrated that ramelteon was effective and well tolerated. Other potential off-label uses of ramelteon include circadian rhythm sleep disorders such as shift-work and jet lag. At the present time the drug should be cautiously prescribed for short-term treatment only.

  4. Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

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    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).

  5. Safety and efficacy of canagliflozin in elderly patients with type 2 diabetes mellitus: a 1-year post-marketing surveillance in Japan.

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    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.

  6. 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

  7. Repeat confirmatory testing for persons with discordant whole blood and oral fluid rapid HIV test results: findings from post marketing surveillance.

    Science.gov (United States)

    Wesolowski, Laura G; Mackellar, Duncan A; Ethridge, Steven F; Zhu, Julia H; Owen, S Michele; Sullivan, Patrick S

    2008-02-06

    Reactive oral fluid and whole blood rapid HIV tests must be followed with a confirmatory test (Western blot (WB), immunofluorescent assay (IFA) or approved nucleic acid amplification test (NAAT)). When the confirmatory result is negative or indeterminate (i.e. discordant with rapid result), repeat confirmatory testing should be conducted using a follow-up specimen. Previous reports have not described whether repeat testing adequately resolves the HIV-infection status of persons with discordant results. Post-marketing surveillance was conducted in 368 testing sites affiliated with 14 state and 2 city health departments from August 11, 2004 to June 30, 2005 and one health department through December 31, 2005. For persons with discordant results, data were collected on demographics, risk behaviors, HIV test results and specimen types. Persons with repeat confirmatory results were classified as HIV-infected or uninfected. Regression models were created to assess risk factors for not having repeat testing. Of 167,371 rapid tests conducted, 2589 (1.6%) were reactive: of these, 2417 (93%) had positive WB/IFA, 172 (7%) had negative or indeterminate WB/IFA. Of 89/172 (52%) persons with a repeat confirmatory test: 17 (19%) were HIV-infected, including 3 with indeterminate WB and positive NAAT; 72 (81%) were uninfected, including 12 with repeat indeterminate WB. Factors associated with HIV-infection included having an initial indeterminate WB/IFA (vs. negative) (ptest [adjusted OR 2.6, 95% CI (1.3, 4.9)]. Though only half of persons with discordant results had repeat confirmatory testing, of those who did, nearly one in five were HIV-infected. These findings underscore the need for rapid HIV testing programs to increase repeat confirmatory testing for persons with discordant results. Because of the lower sensitivity of oral fluid WBs, confirmatory testing following a reactive rapid test should be conducted using serum or plasma, when possible.

  8. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study.

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    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.

  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. [Safety and effectiveness of pemetrexed in patients with non-small cell lung cancer in Japan - analysis of post-marketing surveillance].

    Science.gov (United States)

    Okubo, Sumiko; Kobayashi, Noriko; Taketsuna, Masanori; Kaneko, Naoya; Enatsu, Sotaro; Nishiuma, Shinichi

    2014-04-01

    The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings.

  11. The safety and effectiveness profile of eldecalcitol in a prospective, post-marketing observational study in Japanese male patients with osteoporosis.

    Science.gov (United States)

    Kondo, Satoshi; Kakihata, Hiroyuki; Nishida, Yosuke; Furuno, Yuko; Kobayashi, Yumiko; Tabata, Hidehiro; Nomura, Makoto

    2018-03-12

    We conducted a post-marketing observational study to investigate the safety and effectiveness of eldecalcitol for the treatment of osteoporosis in a Japanese clinical setting. The observation period was 12 months for women and 36 months for men. The final results for the female patients have already been published. In this article, the final results for the male patients are reported. A total of 470 male osteoporosis patients were enrolled. The safety analysis set included 431 patients (mean age, 76.8 years; mean ± SD follow-up period, 631.0 ± 450.3 days), and 175 patients continued treatment throughout the 3-year observational period. Adverse drug reactions (ADRs) were reported in 28 patients (6.49%); the most common ADRs were hypercalcemia (1.16%) and renal impairment (1.16%). Serious ADRs were reported in 5 patients (1.16%). Mean serum calcium was within the normal range throughout the observation period. The cumulative incidence of new vertebral and nonvertebral fractures at 36 months, estimated by Kaplan-Meier analysis, was 10.23 and 4.06%, respectively. At the last observation, mean lumbar spine bone mineral density was 3.49% higher (P effectiveness of eldecalcitol for the treatment of Japanese male osteoporosis patients was confirmed in clinical practice. Careful monitoring of serum calcium and estimated glomerular filtration rate, both before and during treatment, is necessary to minimize the risk of hypercalcemia and renal impairment while maximizing the effectiveness of eldecalcitol.

  12. Effectiveness and safety of tolvaptan in liver cirrhosis patients with edema: Interim results of post-marketing surveillance of tolvaptan in liver cirrhosis (START study).

    Science.gov (United States)

    Sakaida, Isao; Terai, Shuji; Kurosaki, Masayuki; Yasuda, Moriyoshi; Okada, Mitsuru; Bando, Kosuke; Fukuta, Yasuhiko

    2017-10-01

    Loop diuretics and spironolactone are used in patients with hepatic edema, but they are sometimes associated with insufficient responses as well as adverse events. Tolvaptan, a vasopressin type 2 receptor antagonist, was approved for hepatic edema in 2013. A large-scale post-marketing surveillance study has been carried out to evaluate the effectiveness and safety of tolvaptan in real-world clinical settings. Patients with hepatic cirrhosis with insufficient response to conventional diuretics were enrolled. The observational period was up to 6 months. Changes in body weight and clinical symptoms were measured to evaluate effectiveness. The incidence of adverse drug reactions was summarized as a safety measure. Of 970 patients enrolled, 463 were included in the safety analysis. Of this group, 340 were included in the effectiveness analysis. Decreases in body weight from baseline were -2.38 kg on day 7 and -3.52 kg on day 14. Ascites and bloated feeling was significantly improved within 14 days. The mean change in body weight depended on estimated glomerular filtration rate levels. The most frequently reported adverse drug reaction was thirst (6.9% of patients). Serum sodium level of ≥146 mEq/L was observed in 12 patients (2.7%). In the real-world clinical setting, tolvaptan showed aquaretic effectiveness in patients with cirrhosis. The mean change in body weight depended on renal function. We recommend tolvaptan use for hepatic cirrhosis at a stage in which the renal function is maintained. © 2016 The Japan Society of Hepatology.

  13. 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.

  14. Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study.

    Science.gov (United States)

    Yagi, Minami; Tanaka, Atsushi; Namisaki, Tadashi; Takahashi, Atsushi; Abe, Masanori; Honda, Akira; Matsuzaki, Yasushi; Ohira, Hiromasa; Yoshiji, Hitoshi; Takikawa, Hajime

    2018-04-16

    Patients with primary biliary cholangitis (PBC) frequently suffer from pruritus, which can severely impair their health-related quality of life (HRQOL). Nalfurafine hydrochloride, a selective κ-opioid receptor agonist, was recently approved in Japan for refractory pruritus in patients with chronic liver diseases, but it still remains unclear whether this treatment improves the patient-reported outcome (PRO) in PBC patients with refractory pruritus. Herein, we conducted a multicenter, post-marketing, single-arm prospective study to investigate the efficacy of nalfurafine in terms of PRO, and the associations of the efficacy with any clinical characteristics. After screening for pruritus in 496 patients with PBC using PBC-40 and the visual analog scale (VAS), we identified 141 patients with moderate to severe pruritus; these were invited to participate in the study. The participants received 2.5 μg nalfurafine once daily for 12 weeks, and pruritus and HRQOL were assessed in week 12 of this treatment. Generic HRQOL, short form 36, blood chemistries, and serum autotaxin levels were also measured at baseline and at week 12. Forty-four patients participated in this study. The mean PBC-40 itch domain scores and VAS declined during the study period, from 8.56 to 7.63 (P = 0.041) and from 42.9 to 29.3 (P = 0.001) at baseline and at week 12, respectively, indicating a significant effect of nalfurafine. The other domains of PBC-40 and all domains of SF-36 were not significantly altered by this treatment. We failed to find any association between the change in VAS and PBC-40 itch scores and any clinical variable. Serum autotaxin levels were significantly increased during the study period. This study demonstrated that nalfurafine improved pruritus in patients with PBC, independent of their clinical characteristics, but had a limited effect on the PRO.

  15. 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.

  16. Psychosocial functioning in patients with schizophrenia treated with aripiprazole - an office-based real-world setting. Results from the German post-marketing surveillance study.

    Science.gov (United States)

    Bergmann, F; Zacher, A; Nass, A; Urban, R; Werner, C; Spevakné-Göröcs, T; Kungel, M; Ebrecht, M; Modell, S

    2009-05-01

    Aripiprazole (ABILIFY) is an effective antipsychotic used in a dose range from 10 to 30 mg, administered once daily. Soon after its approval in Germany for treatment of schizophrenia, a 12-month post-marketing surveillance study was initiated that included 1 096 patients cared for by 408 office-based psychiatrists and/or neurologists in private practice. The aim was to gain further insights into safety and efficacy of aripiprazole in an outpatient real-life setting focusing on general health, well-being and psychosocial functioning. Efficacy was rated by using standard CGI, SF-12 and SIWM-PsySo instruments for severity of disease, physical and mental health outcomes and psychosocial state, respectively. Safety was evaluated according to the reports of adverse events. Mean total daily dose of aripiprazole increased from 15.4 mg at the visit after 1 month to 17.6 mg at the visits after 6 to 12 months, the most frequently administered maintenance dose being 15 mg. Within the observation period significant improvements of CGI, SF-12 and SIWM-PsySo scores over time versus baseline values were observed (pmuch" or "very much" improved. Aripiprazole was overall well tolerated; 19.9% of patients discontinued treatment after 12 months. Adverse effects in general were moderate to mild and corresponded to the known tolerability profile of aripiprazole. Psychotic side effects reported were probably due to a recurrence of the underlying schizophrenic disorder. The results indicate that aripiprazole may be an efficacious and safe treatment option for pre-treated patients with schizophrenia also in a naturalistic psychiatrist/neurologist practice setting with effects on health and psychosocial functioning and a comparably low dropout rate.

  17. Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

    International Nuclear Information System (INIS)

    Endrikat, J.; Schwenke, C.; Prince, M.R.

    2015-01-01

    Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

  18. 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

  19. Prevalence of insomnia and its impact on daily function amongst Malaysian primary care patients

    Directory of Open Access Journals (Sweden)

    Zailinawati Abu-Hassan

    2012-11-01

    Full Text Available Abstract Background Insomnia is a common public health problem and the prevalence and impact of insomnia in primary care attendees is not well documented in the Asian population. Objectives To determine the prevalence of self-reported insomnia symptoms amongst adult primary care attendees and the association with socio-demographic factors; to ascertain the impact of insomnia on daily functioning and to describe the psychological profile of patients with insomnia. Methods In this cross-sectional survey, 2049 adult patients (≥18 year old attending seven primary care clinics in Peninsular Malaysia, completed the questionnaire asking about symptoms of insomnia (defined according to the International Classification of Sleep Disorders and DSM IV criteria daytime impairment and psychological symptoms (assessed by Hospital Anxiety and Depression Scale. Results The response rate was 86.2%. A total of 60% reported insomnia symptoms, 38.9% had frequent insomnia symptoms (>3 times per week, 30.7% had chronic insomnia without daytime consequences and 28.6% had chronic insomnia with daytime dysfunction. Indian ethnicity (OR 1.79; 95%CI, 1.28-2.49, age ≥ 50 or older (OR 1.82; 95%CI, 1.10-3.01, anxiety symptoms (OR 1.65; 95%CI, 1.21-2.22 and depression symptoms (OR 1.65; 95%CI, 1.21-2.26 were risk factors for chronic insomnia with daytime dysfunction. Amongst those with chronic insomnia with daytime dysfunction, 47.8% had anxiety symptoms (OR, 2.01; 95%CI, 1.57-2.59 and 36.5% had depression symptoms (OR, 2.74; 95%CI, 2.04-3.68 based on HADs score. They also had tendency to doze off while driving and to be involved in road traffic accidents. Conclusions A third of primary care attendees have insomnia symptoms and chronic insomnia, associated with significant daytime dysfunction and psychological morbidity. By identifying those at risk of having chronic insomnia, appropriate interventions can be commenced.

  20. 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.

  1. 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.

  2. Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Zachariae, Robert; Amidi, Ali; Damholdt, Malene F

    2018-01-01

    Background: Insomnia is two to three times more prevalent in cancer survivors than in the general population, where it is estimated to be 10% to 20%. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, but meeting survivor needs remains a challenge...

  3. Internet-delivered cognitive-behavioral therapy for insomnia in women treated for breast cancer: a randomized controlled trial

    DEFF Research Database (Denmark)

    Zachariae, Robert Hugh; Amidi, Ali; Damholdt, Malene

    2018-01-01

    Background Insomnia is two to three times more prevalent in cancer survivors than in the general population, where it is estimated to be 10% to 20%. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, but meeting survivor needs remains a challenge....

  4. 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).

  5. 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

  6. 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

  7. Insomnia in workers with delayed recovery from mild traumatic brain injury

    DEFF Research Database (Denmark)

    Mollayeva, Tatyana; Mollayeva, Shirin; Shapiro, Colin M

    2016-01-01

    Objective/Background/Aim Insomnia has not been explored as it relates to recovery after mild traumatic brain injury (mTBI). We aimed to evaluate the prevalence of insomnia among Ontario workers with delayed recovery from mTBI, and its relationship with sociodemographic, TBI- and claim-related, be...

  8. 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

  9. 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

  10. 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.

  11. 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…

  12. 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.

  13. 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

  14. 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

  15. 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 D

    2012-10-01

    To determine the prevalence of personality disorders and their relation to insomnia parameters among persons with chronic insomnia with hypnotic dependence. 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. 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. 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. Copyright © 2012 Elsevier B.V. All rights reserved.

  16. Barriers to Engagement in Sleep Restriction and Stimulus Control in Chronic Insomnia

    Science.gov (United States)

    Vincent, Norah; Lewycky, Samantha; Finnegan, Heather

    2008-01-01

    Sleep restriction (SRT) and stimulus control (SC) have been found to be effective interventions for chronic insomnia (Morgenthaler et al., 2006), and yet adherence to SRT and SC varies widely. The objective of this study was to investigate correlates to adherence to SC/SRT among 40 outpatients with primary or comorbid insomnia using a…

  17. 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…

  18. 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.

  19. 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

  20. 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

  1. Phenotypes of sleeplessness : stressing the need for psychodiagnostics in the assessment of insomnia

    NARCIS (Netherlands)

    van de Laar, M.; Leufkens, T.; Bakker, B.; Pevernagie, D.; Overeem, S.

    2017-01-01

    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

  2. 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

  3. 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…

  4. Improvements of adolescent psychopathology after insomnia treatment : Results from a randomized controlled trial over 1 year

    NARCIS (Netherlands)

    de Bruin, E.J.; Bögels, S.M.; Oort, F.J.; Meijer, A.M.

    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

  5. 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.…

  6. Melatonin for chronic sleep onset insomnia in children: A Randomized placebo-controlled study

    NARCIS (Netherlands)

    Smits, M.G.; Nagtegaal, J.E.; Heijden, J.A.M. van der; Coenen, A.M.L.; Kerkhof, G.A.

    2001-01-01

    To establish the efficacy of melatonin treatment in childhood sleep onset insomnia, 40 elementary school children, 6 to 12 years of age, who suffered more than 1 year from chronic sleep onset insomnia, were studied in a double-blind, placebo-controlled study. The children were randomly assigned to

  7. 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.

  8. Simplified sleep restriction for insomnia in general practice: a randomised controlled trial.

    Science.gov (United States)

    Falloon, Karen; Elley, C Raina; Fernando, Antonio; Lee, Arier C; Arroll, Bruce

    2015-08-01

    Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I. To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia. Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand. Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined 'insomnia remission' treatment response was calculated. Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, Pinsomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects. SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice. © British Journal of General Practice 2015.

  9. 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.

  10. (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…

  11. 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.

  12. 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…

  13. 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

  14. 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

  15. 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

  16. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing phase IV study

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    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

  17. 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.

  18. Repeat confirmatory testing for persons with discordant whole blood and oral fluid rapid HIV test results: findings from post marketing surveillance.

    Directory of Open Access Journals (Sweden)

    Laura G Wesolowski

    Full Text Available BACKGROUND: Reactive oral fluid and whole blood rapid HIV tests must be followed with a confirmatory test (Western blot (WB, immunofluorescent assay (IFA or approved nucleic acid amplification test (NAAT. When the confirmatory result is negative or indeterminate (i.e. discordant with rapid result, repeat confirmatory testing should be conducted using a follow-up specimen. Previous reports have not described whether repeat testing adequately resolves the HIV-infection status of persons with discordant results. METHODOLOGY: Post-marketing surveillance was conducted in 368 testing sites affiliated with 14 state and 2 city health departments from August 11, 2004 to June 30, 2005 and one health department through December 31, 2005. For persons with discordant results, data were collected on demographics, risk behaviors, HIV test results and specimen types. Persons with repeat confirmatory results were classified as HIV-infected or uninfected. Regression models were created to assess risk factors for not having repeat testing. PRINCIPAL FINDINGS: Of 167,371 rapid tests conducted, 2589 (1.6% were reactive: of these, 2417 (93% had positive WB/IFA, 172 (7% had negative or indeterminate WB/IFA. Of 89/172 (52% persons with a repeat confirmatory test: 17 (19% were HIV-infected, including 3 with indeterminate WB and positive NAAT; 72 (81% were uninfected, including 12 with repeat indeterminate WB. Factors associated with HIV-infection included having an initial indeterminate WB/IFA (vs. negative (p<0.001 and having an initial oral fluid WB (vs. serum (p<0.001. Persons who had male-female sex (vs. male-male sex were at increased risk for not having a repeat test [adjusted OR 2.6, 95% CI (1.3, 4.9]. CONCLUSIONS: Though only half of persons with discordant results had repeat confirmatory testing, of those who did, nearly one in five were HIV-infected. These findings underscore the need for rapid HIV testing programs to increase repeat confirmatory testing for

  19. Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance.

    Science.gov (United States)

    Haneda, Masakazu; Kadowaki, Takashi; Ito, Hiroshi; Sasaki, Kazuyo; Hiraide, Sonoe; Ishii, Manabu; Matsukawa, Miyuki; Ueno, Makoto

    2018-06-01

    Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1-G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98-6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was - 0.68 to - 0.85% and - 0.71 to - 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [- 2.29%, (p < 0.001) after 1 year; - 1.64%, (p = 0.064) after 2 years]. During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from

  20. Relationship of Eating Patterns and Metabolic Parameters, and Teneligliptin Treatment: Interim Results from Post-marketing Surveillance in Japanese Type 2 Diabetes Patients.

    Science.gov (United States)

    Kadowaki, Takashi; Haneda, Masakazu; Ito, Hiroshi; Sasaki, Kazuyo; Hiraide, Sonoe; Matsukawa, Miyuki; Ueno, Makoto

    2018-06-01

    Healthy eating is a critical aspect of the prevention and management of type 2 diabetes (T2DM). Disrupted eating patterns can result in poor glucose control and increase the likelihood of diabetic complications. Teneligliptin inhibits dipeptidyl peptidase-4 activity for 24 h and suppresses postprandial hyperglycemia after all three daily meals. This interim analysis of data from the large-scale post-marketing surveillance of teneligliptin (RUBY) in Japan examined eating patterns and their relationship with metabolic parameters and diabetic complications. We also examined whether eating patterns affected safety and efficacy of teneligliptin. We analyzed baseline data from survey forms collected in RUBY between May 2013 and June 2017, including patient characteristics, metabolic parameters, and eating patterns (eating three meals per day or not; timing of evening meal) before teneligliptin treatment was initiated. Safety and efficacy of 12 months' teneligliptin (20-40 mg/day) treatment was assessed. Data from 10,532 patients were available for analysis. Most patients who did not eat three meals per day (n  =757) or who ate their evening meal after 10 PM (n  =206) were 64 years old or younger. At baseline, glycated hemoglobin (HbA1c), fasting blood glucose, triglycerides, total and low-density lipoprotein cholesterol, body mass index, alanine aminotransferase, and aspartate aminotransferase levels were higher in those patients who did not eat three meals per day (p < 0.05) or who ate their evening meal late (p < 0.05). Diabetic complications were more common in patients who did not eat three meals per day. Treatment with teneligliptin reduced HbA1c over 6 or 12 months across all eating patterns, with a low incidence of adverse drug reactions. Eating patterns may be associated with altered metabolic parameters and diabetic complications among Japanese patients with T2DM. Teneligliptin may be well tolerated and improve hyperglycemia in patients

  1. An examination of the relationship between binge eating disorder and insomnia symptoms.

    Science.gov (United States)

    Kenny, Therese E; Van Wijk, Megan; Singleton, Christopher; Carter, Jacqueline C

    2018-05-01

    Although studies on sleep difficulties in binge eating disorder (BED) have produced inconsistent findings, research has linked poor sleep to the presence of related concerns (e.g., obesity, anxiety, and depression). To clarify the relationship between BED and sleep problems, this study aimed to compare insomnia symptoms in individuals with BED and those with no history of an eating disorder (NED). An adult community sample of individuals with BED (N = 68) and NED (N = 78) completed measures of insomnia, depression and anxiety, and eating disorder symptoms. Individuals with BED reported significantly greater insomnia symptoms than the NED group. The relationship between BED and insomnia symptoms was partially mediated by anxiety. Depression fully mediated the positive association between insomnia symptom severity and binge frequency in the BED group. These findings suggest that depression, anxiety, and sleep are important constructs to consider in BED development and presentation. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

  2. Intensive sleep deprivation and cognitive behavioral therapy for pharmacotherapy refractory insomnia in a hospitalized patient.

    Science.gov (United States)

    Breitstein, Joshua; Penix, Brandon; Roth, Bernard J; Baxter, Tristin; Mysliwiec, Vincent

    2014-06-15

    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, were initiated on the ward. After two consecutive nights with improved sleep, anxiety, and absence of suicidal ideation, the patient was discharged. She was followed in the sleep clinic for two months engaging in CBTi. Treatment resulted in substantial improvement in her insomnia, daytime sleepiness, and anxiety about sleep. Sleep deprivation regimens followed by a restricted sleep recovery period have shown antidepressant effects in depressed patients. Similar treatment protocols have not been investigated in patients with pharmacotherapy refractory insomnia and generalized anxiety disorder.

  3. Telehealth Cognitive Behavior Therapy for Co-Occurring Insomnia and Depression Symptoms in Older Adults

    Science.gov (United States)

    Lichstein, Kenneth L.; Scogin, Forrest; Thomas, S. Justin; DiNapoli, Elizabeth A.; Dillon, Haley R.; McFadden, Anna

    2015-01-01

    Objective Telehealth has proven effective with a wide range of disorders, but there is a paucity of data on the use of telehealth using cognitive-behavior therapy (CBT) with late-life insomnia and depression. This pilot study was designed to examine the feasibility and effectiveness of using telehealth to treat older adults with comorbid insomnia and depression living in rural Alabama. Method Five patients received 10 sessions of CBT for insomnia and depression. Patients were engaged in treatment via Skype from their primary care physician’s office. Assessments were conducted at baseline, posttreatment, and 2-month follow-up. Results Patients exhibited clinically significant improvement in both insomnia (sleep diaries and Insomnia Severity Index) and depression (Hamilton Rating Scale for Depression) at posttreatment, and these gains were well maintained at 2-month follow-up. Conclusions These preliminary data suggest that telehealth may be an effective means of providing treatment to older adults, including underserved populations. PMID:24014056

  4. Faktor-Faktor Yang Mempengaruhi Kejadian Insomnia di Poliklinik Saraf RS DR. M. Djamil Padang

    Directory of Open Access Journals (Sweden)

    Lydia Susanti

    2015-09-01

    Full Text Available 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 sectional. Jumlah sampel dihitung menggunakan rumus yang dikembangkan oleh Snedecor & Cochran dan didapatkan jumlah sampel 100 orang. Pengambilan sampel dilakukan secara acakdimana pasien yang memenuhi kriteria inklusi langsung menjadi sampel penelitian. Pengambilan data menggunakan kuesioner dan beberapa skala, Insomnia Severity Index, dan Beck depression inventory scale. Data dikumpulkan dari t 1 Juli sampai 31 Agustus 2013. Data ditampilkan dalam bentuk tabel distribusi frekuensi dan dilakukan analisis bivariatdan multivariat.  Kejadian Insomnia dialami oleh 38% (38 orang pasien yang berkunjung ke poliklinik saraf RS DR. M.Djamil Padang dengan jenis kelamin terbanyak pada wanita 24(45,3% dan pada kelompok umur  61-70 tahun (3,3%. Insomnia berhubungan dengan depresi (p= 0,00 dan tidak berhubungan dengan umur (p=0,472, jenis kelamin (p=0,111, status ekonomi (p=0,075, riwayat insomnia di keluarga (p=0,197. Depresi (p=0,00; OR=9,20 dan nyeri  kronik (p=0,031; OR=4.253 merupakan faktor yang dominan berhubungan dengan kejadian Insomnia. Kata Kunci: insomnia, tidur, insomnia severity index, beck depression inventory scaleAbstract A number of risk factors such as advanced age, female gender, co-morbidities (such as depression and other diseases, low socioeconomic status causes insomnia. Research on the frequency of insomnia in DR. M. Djamil hospital Padang has never been done. The objective of this study was to determine the factors that influence the incidence

  5. Changes in Cognitive Performance Are Associated with Changes in Sleep in Older Adults With Insomnia.

    Science.gov (United States)

    Wilckens, Kristine A; Hall, Martica H; Nebes, Robert D; Monk, Timothy H; Buysse, Daniel J

    2016-01-01

    The present study examined sleep features associated with cognition in older adults and examined whether sleep changes following insomnia treatment were associated with cognitive improvements. Polysomnography and cognition (recall, working memory, and reasoning) were assessed before and after an insomnia intervention (Brief Behavioral Treatment of Insomnia [BBTI] or information control [IC]) in 77 older adults with insomnia. Baseline wake-after-sleep-onset (WASO) was associated with recall. Greater NREM (nonrapid eye movement) delta power and lower NREM sigma power were associated with greater working memory and reasoning. The insomnia intervention did not improve performance. However, increased absolute delta power and decreased relative sigma power were associated with improved reasoning. Findings suggest that improvements in executive function may occur with changes in NREM architecture.

  6. 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 and were associated with similar objective indices and a subjective insomnia severity measure. The ability to detect treatment improvements after cognitive behavior therapy for insomnia (CBT-I) was tested by comparing pre- and post-CBT-I CSD indices with a subjective rating of insomnia symptom severity. Improvement in insomnia symptom severity was significantly related to improvement on the CSD indices. Completion rate of the CSD amongst participants across all 14 days was 99.8%. These findings provide support for the validity, clinical utility, and usability of the CSD.

  7. 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.

  8. Patient-reported outcomes in insomnia: development of a conceptual framework and endpoint model.

    Science.gov (United States)

    Kleinman, Leah; Buysse, Daniel J; Harding, Gale; Lichstein, Kenneth; Kalsekar, Anupama; Roth, Thomas

    2013-01-01

    This article describes qualitative research conducted with patients with clinical diagnoses of insomnia and focuses on the development of a conceptual framework and endpoint model that identifies a hierarchy and interrelationships of potential outcomes in insomnia research. Focus groups were convened to discuss how patients experience insomnia and to generate items for patient-reported questionnaires on insomnia and associated daytime consequences. Results for the focus group produced two conceptual frameworks: one for sleep and one for daytime impairment. Each conceptual framework consists of hypothesized domains and items in each domain based on patient language taken from the focus group. These item pools may ultimately serve as a basis to develop new questionnaires to assess insomnia.

  9. 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.

  10. 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 (<1%), mild, and self-limiting, consisting mainly of skin irritation under the electrodes and headaches. Often used as a stand-alone therapy, because results are usually seen from the first treatment, cranial electrotherapy stimulation may also be used as an adjunctive therapy. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. POLARIZED LIGHT APPLICATION AT CHRONIC INSOMNIA AND HABIT OF SMOKING

    Directory of Open Access Journals (Sweden)

    D. Tubič

    2016-06-01

    Full Text Available 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 for smoking and an increase in the wish for final putting an end to smoke.

  12. Qualitative Studies of Insomnia: Current State of Knowledge in the Field

    Science.gov (United States)

    Araújo, Taís; Jarrin, Denise C.; Leanza, Yvan; Vallières, Annie; Morin, Charles M.

    2016-01-01

    Summary Despite its high prevalence and burden, insomnia is often trivialized, under-diagnosed, and under-treated in practice. Little information is available on the subjective experience and perceived consequences of insomnia, help-seeking behaviors, and treatment preferences. The use of qualitative approaches (e.g., ethnography, phenomenology, grounded theory) may help gain a better understanding of this sleep disorder. The present paper summarizes the evidence derived from insomnia studies using a qualitative research methodology (e.g., focus group, semi-structured interviews). A systematic review of the literature was conducted using PsycINFO and Medline databases. The review yielded 22 studies and the quality of the methodology of each of them was evaluated systematically using the CASP appraisal tool. Selected articles possess at least a very good methodological rigor and they were categorized according to their main focus: “Experience of insomnia”, “Management of insomnia” and “Medicalization of insomnia”. The main findings indicate that: 1) insomnia is often experienced as a 24-hour problem and is perceived to affect several domains of life, 2) a sense of frustration and misunderstanding is very common among insomnia patients, which is possibly due to a mismatch between patients’ and health care professionals’ perspectives on insomnia and its treatment, 3) health care professionals pay more attention to sleep hygiene education and medication therapies and less to the patient’s subjective experience of insomnia, and 4) health care professionals are often unaware of non-pharmacological interventions other than sleep hygiene education. An important implication of these findings is the need to develop new clinical measures with a broader scope on insomnia and more targeted treatments that take into account the patient’s experience of insomnia. Greater use of qualitative approaches in future research may produce novel and more contextualized

  13. Sleep spindles may predict response to cognitive-behavioral therapy for chronic insomnia.

    Science.gov (United States)

    Dang-Vu, Thien Thanh; Hatch, Benjamin; Salimi, Ali; Mograss, Melodee; Boucetta, Soufiane; O'Byrne, Jordan; Brandewinder, Marie; Berthomier, Christian; Gouin, Jean-Philippe

    2017-11-01

    While cognitive-behavioral therapy for insomnia constitutes the first-line treatment for chronic insomnia, only few reports have investigated how sleep architecture relates to response to this treatment. In this pilot study, we aimed to determine whether pre-treatment sleep spindle density predicts treatment response to cognitive-behavioral therapy for insomnia. Twenty-four participants with chronic primary insomnia participated in a 6-week cognitive-behavioral therapy for insomnia performed in groups of 4-6 participants. Treatment response was assessed using the Pittsburgh Sleep Quality Index and the Insomnia Severity Index measured at pre- and post-treatment, and at 3- and 12-months' follow-up assessments. Secondary outcome measures were extracted from sleep diaries over 7 days and overnight polysomnography, obtained at pre- and post-treatment. Spindle density during stage N2-N3 sleep was extracted from polysomnography at pre-treatment. Hierarchical linear modeling analysis assessed whether sleep spindle density predicted response to cognitive-behavioral therapy. After adjusting for age, sex, and education level, lower spindle density at pre-treatment predicted poorer response over the 12-month follow-up, as reflected by a smaller reduction in Pittsburgh Sleep Quality Index over time. Reduced spindle density also predicted lower improvements in sleep diary sleep efficiency and wake after sleep onset immediately after treatment. There were no significant associations between spindle density and changes in the Insomnia Severity Index or polysomnography variables over time. These preliminary results suggest that inter-individual differences in sleep spindle density in insomnia may represent an endogenous biomarker predicting responsiveness to cognitive-behavioral therapy. Insomnia with altered spindle activity might constitute an insomnia subtype characterized by a neurophysiological vulnerability to sleep disruption associated with impaired responsiveness to

  14. Reduced spontaneous neuronal activity in the insular cortex and thalamus in healthy adults with insomnia symptoms.

    Science.gov (United States)

    Liu, Chun-Hong; Liu, Cun-Zhi; Zhang, Jihui; Yuan, Zhen; Tang, Li-Rong; Tie, Chang-Le; Fan, Jin; Liu, Qing-Quan

    2016-10-01

    Poor sleep and insomnia have been recognized to be strongly correlated with the development of depression. The exploration of the basic mechanism of sleep disturbance could provide the basis for improved understanding and treatment of insomnia and prevention of depression. In this study, 31 subjects with insomnia symptoms as measured by the Hamilton Rating Scale for Depression (HAMD-17) and 71 age- and gender-matched subjects without insomnia symptoms were recruited to participate in a clinical trial. Using resting-state functional magnetic resonance imaging (rs-fMRI), we examined the alterations in spontaneous brain activity between the two groups. Correlations between the fractional amplitude of low frequency fluctuations (fALFF) and clinical measurements (e.g., insomnia severity and Hamilton Depression Rating Scale [HAMD] scores) were also tested in all subjects. Compared to healthy participants without insomnia symptoms, participants with insomnia symptoms showed a decreased fALFF in the left ventral anterior insula, bilateral posterior insula, left thalamus, and pons but an increased fALFF in the bilateral middle occipital gyrus and right precentral gyrus. More specifically, a significant, negative correlation of fALFF in the left thalamus with early morning awakening scores and HAMD scores in the overall sample was identified. These results suggest that insomnia symptoms are associated with altered spontaneous activity in the brain regions of several important functional networks, including the insular cortex of the salience and the thalamus of the hyperarousal network. The altered fALFF in the left thalamus supports the "hyperarousal theory" of insomnia symptoms, which could serve as a biomarker for insomnia. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Cognitive-emotional hyperarousal in the offspring of parents vulnerable to insomnia: a nuclear family study.

    Science.gov (United States)

    Fernandez-Mendoza, Julio; Shaffer, Michele L; Olavarrieta-Bernardino, Sara; Vgontzas, Alexandros N; Calhoun, Susan L; Bixler, Edward O; Vela-Bueno, Antonio

    2014-10-01

    Cognitive-emotional hyperarousal is believed to be a predisposing factor for insomnia; however, there is limited information on the association of familial vulnerability to insomnia and cognitive-emotional hyperarousal. The aim of this study was to estimate the heritability of stress-related insomnia and examine whether parental vulnerability to stress-related insomnia is associated with cognitive-emotional hyperarousal in their offspring. We studied a volunteer sample of 135 nuclear families comprised of 270 middle-aged (51.5 ± 5.4 years) fathers and mothers and one of their biological offspring (n = 135, 20.2 ± 1.1 years). We measured vulnerability to stress-related insomnia (i.e. Ford Insomnia Response to Stress Test: FIRST), perceived stress, depression and anxiety in all participants, and arousability, presleep cognitive and somatic arousal, coping and personality in the offspring. We found a heritability estimate of 29% for FIRST scores. High FIRST parents had three to seven times the odds of having offspring highly vulnerable to stress-related insomnia. Offspring of high FIRST parents showed higher arousability, presleep cognitive arousal and emotion-oriented coping. Furthermore, high FIRST mothers contributed to offspring's higher anxiety and lower task-oriented coping, while high FIRST fathers contributed to offspring's higher presleep somatic arousal and conscientiousness. Vulnerability to stress-related insomnia is significantly heritable. Parents vulnerable to stress-related insomnia have offspring with cognitive-emotional hyperarousal who rely upon emotion-oriented coping. These data give support to the notion that arousability and maladaptive coping are key factors in the aetiology of insomnia. © 2014 European Sleep Research Society.

  16. Insomnia and incident depression: role of objective sleep duration and natural history.

    Science.gov (United States)

    Fernandez-Mendoza, Julio; Shea, Sarah; Vgontzas, Alexandros N; Calhoun, Susan L; Liao, Duanping; Bixler, Edward O

    2015-08-01

    Longitudinal studies that have examined the association of insomnia with incident depression using objective sleep measures are very limited. The aim of this study was to examine the predictive role of the severity of insomnia for incident depression in a general population sample using psychometric and polysomnographic data. From a random, general population sample of 1741 individuals of the Penn State Adult Cohort, 1137 adults without depression were followed up with a structured telephone interview after 7.5 years. All subjects completed a full medical evaluation, 1-night polysomnogram and Multiphasic Minnesota Personality Inventory at baseline. The incidence of depression was 15%. Poor sleep (odds ratio = 1.5, P = 0.001) and insomnia (odds ratio = 1.9, P = 0.031) were significantly associated with incident depression. The odds of incident depression were highest (odds ratio = 2.2, P = 0.019) in insomnia with objective short sleep duration and independent of Multiphasic Minnesota Personality Inventory Ego Strength scores, an index of poor coping resources. The persistence of insomnia and worsening of poor sleep into insomnia significantly increased the odds of incident depression (odds ratios ranged from 1.8 to 6.3), whereas their full remission did not (odds ratio ranged from 1.2 to 1.8). Insomnia with short sleep duration is associated with incident depression independent of poor coping resources, whereas the association of insomnia with normal sleep duration with incident depression was mediated by poor coping resources. Persistence and worsening of poor sleep or insomnia, but not their full remission, are significant predictors of incident depression. These data suggest that there is a significant relationship between the severity of insomnia and incident depression. © 2015 European Sleep Research Society.

  17. Joint associations of sleep duration and insomnia symptoms with subsequent sickness absence: the Helsinki Health Study.

    Science.gov (United States)

    Lallukka, Tea; Haaramo, Peija; Rahkonen, Ossi; Sivertsen, Børge

    2013-07-01

    We aimed to examine the joint associations of sleep duration and insomnia symptoms with subsequent sickness absence of various lengths while considering several covariates. Baseline surveys among 40-60-year-old employees of the City of Helsinki, Finland, (N = 6535) were prospectively linked with employer's personnel register data comprising short self-certified (1-3 days), medically-certified intermediate (4-14 days) and long (15 days or more) sickness absence spells. Average follow-up time was 4.1 years. Sleep duration, insomnia symptoms, sociodemographics, working conditions, health behaviours and health were self-reported in the surveys. Poisson regression analysis was used. Insomnia symptoms were associated with sickness absence at all levels of sleep duration. Adjusting for gender and age, U-shaped associations regarding sleep hours were found. Thus, those reporting short or long sleep and reporting insomnia symptoms had a higher risk for medically-certified intermediate and long sickness absence as compared to those reporting 7 hours of sleep without insomnia symptoms. Also, those reporting 6, 7, and 8 hours of sleep had a higher risk for such sickness absence, if they reported insomnia. Weak associations were also found for self-certified sickness absence, and for those reporting short and long sleep without insomnia. Adjustments attenuated the associations, but they mainly remained. These results suggest primacy of the effects of insomnia symptoms over sleep duration on sickness absence. Although insomnia dominated the joint association, U-shaped associations suggest that both sleep duration and insomnia symptoms need to be considered to promote work ability.

  18. [A contemporary conception of insomnia syndrome and its treatments in view of International classification of sleep disorders].

    Science.gov (United States)

    Poluektov, M G; Tsenteradze, S L

    2014-01-01

    Insomnia is one of the most common and wide-spread sleep disorders. It includes difficulties of sleep initiation, sustaining and daytime impairment. A condition of cerebral hyperarousal plays the most important role in the genesis of insomnia. Cognitive, electrophysiological and metabolic parameters are correlated with hyperarousal state. According to the International classification of sleep disorders (ICSD-3), insomnia is divided into acute, chronic and unclassified. Treatment of insomnia includes specific and nonspecific approaches. Regardless of the origin of insomnia, sleep hygiene and behavioral therapy remain the methods of choice for the treatment.

  19. Study on insomnia and sleep quality in adolescents and their correlation analysis

    Directory of Open Access Journals (Sweden)

    Xian LUO

    2017-09-01

    Full Text Available Objective To investigate the correlation between insomnia and sleep quality in adolescents. Methods According to Insomnia Severity Index (ISI Chinese Version, 3342 students technician training in school were divided into non insomnia group (N = 2345 and insomnia group (N = 997. Sleep and emotional state were assessed by ISI Chinese Version, Pittsburgh Sleep Quality Index (PSQI, Epworth Sleepiness Scale (ESS, Self?Rating Anxiety Scale (SAS and Beck Depression Inventory (BDI. The social demographic data were collected simultaneously. Results The number of insomnia, daytime sleepiness, anxiety and depression in the population was 997 (29.83%, 568 (17.00%, 243 (7.27% and 1287 (38.51%, respectively. The comparison of social demographic data between 2 groups showed that the proportion of female (P = 0.000, poor physical condition (P = 0.000, non?only child (P = 0.006, high learning pressure (P = 0.000 and smoking (P = 0.027 in insomnia group were significantly higher than those in non insomnia group. The total scores of ISI Chinese Version (P = 0.000, ESS (P = 0.000, SAS (P = 0.000 and BDI (P = 0.000 in insomnia group were significantly higher than those in non insomnia group. Pearson correlation analysis showed that ISI Chinese Version and PSQI scores were positively correlated with ESS score (r = 0.361, P = 0.000; r = 0.064, P = 0.000, SAS score (r = 0.326, P = 0.000; r = 0.069, P = 0.000 and BDI score (r = 0.529, P = 0.000; r = 0.067, P = 0.000, and ISI Chinese Version had higher correlation (r = 0.300-0.600 with the above scores than PSQI (r < 0.100. Further partial correlation analysis showed that ISI Chinese Version score was negatively correlated with PSQI score (r = - 0.056, P = 0.001. Conclusions Higher proportion of female, worse physical condition, more non?only child, greater learning pressure and higher smoking rate were observed in insomnia group. Daytime sleepiness, anxiety and depression in insomnia group were more serious than those

  20. Sleep-Related Safety Behaviors and Dysfunctional Beliefs Mediate the Efficacy of Online CBT for Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Lancee, Jaap; Eisma, Maarten C; van Straten, Annemieke; Kamphuis, Jan H

    2015-01-01

    Several trials have demonstrated the efficacy of online cognitive behavioral therapy (CBT) for insomnia. However, few studies have examined putative mechanisms of change based on the cognitive model of insomnia. Identification of modifiable mechanisms by which the treatment works may guide efforts to further improve the efficacy of insomnia treatment. The current study therefore has two aims: (1) to replicate the finding that online CBT is effective for insomnia and (2) to test putative mechanism of change (i.e., safety behaviors and dysfunctional beliefs). Accordingly, we conducted a randomized controlled trial in which individuals with insomnia were randomized to either online CBT for insomnia (n = 36) or a waiting-list control group (n = 27). Baseline and posttest assessments included questionnaires assessing insomnia severity, safety behaviors, dysfunctional beliefs, anxiety and depression, and a sleep diary. Three- and six-month assessments were administered to the CBT group only. Results show moderate to large statistically significant effects of the online treatment compared to the waiting list on insomnia severity, sleep measures, sleep safety behaviors, and dysfunctional beliefs. Furthermore, dysfunctional beliefs and safety behaviors mediated the effects of treatment on insomnia severity and sleep efficiency. Together, these findings corroborate the efficacy of online CBT for insomnia, and suggest that these effects were produced by changing maladaptive beliefs, as well as safety behaviors. Treatment protocols for insomnia may specifically be enhanced by more focused attention on the comprehensive fading of sleep safety behaviors, for instance through behavioral experiments.

  1. Regional homogeneity changes in patients with primary insomnia

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    Wang, Tianyue [Guangdong No. 2 Provincial People' s Hospital of Southern Medical University, The Third Clinical Medical College of Southern Medical University, Guangzhou (China); Li, Shumei; Jiang, Guihua; Lin, Chulan; Li, Meng; Ma, Xiaofen; Zhan, Wenfeng; Fang, Jin; Li, Liming; Li, Cheng; Tian, Junzhang [Guangdong No. 2 Provincial People' s Hospital of Southern Medical University, Guangzhou (China)

    2016-05-15

    The study aimed to explore the regional spontaneous activity changes in primary insomnia (PI) patients. Based on the resting-state fMRI datasets acquired from 59 PI patients and 47 healthy controls, a two-sample t-test was performed on individual normalized regional homogeneity (ReHo) maps. Relationships between abnormal ReHo values and the Pittsburgh Sleep Quality Index (PSQI), the self-rating anxiety scale (SAS) and the self-rating depression scale (SDS) were investigated with Pearson correlation analysis. In PI patients, we found increased ReHo in the left insula, right anterior cingulate gyrus, bilateral precentral gyrus and left cuneus, as well as decreased ReHo in the right middle cingulate cortex and left fusiform (p < 0.05, AlphaSim-corrected). We also found a significant positive correlation between increased ReHo in the left insula and SAS scores, decreased ReHo in the right middle cingulated cortex and SDS, SAS scores as well as a negative correlation between increased ReHo in the right precentral gyrus and SDS scores (p < 0.05). Our study found abnormal spontaneous activities in multiple brain regions, especially in emotion-related areas in PI patients. Alterative activities in these regions might contribute to an understanding the intrinsic functional architecture of insomnia and its clinical features. (orig.)

  2. Regional homogeneity changes in patients with primary insomnia

    International Nuclear Information System (INIS)

    Wang, Tianyue; Li, Shumei; Jiang, Guihua; Lin, Chulan; Li, Meng; Ma, Xiaofen; Zhan, Wenfeng; Fang, Jin; Li, Liming; Li, Cheng; Tian, Junzhang

    2016-01-01

    The study aimed to explore the regional spontaneous activity changes in primary insomnia (PI) patients. Based on the resting-state fMRI datasets acquired from 59 PI patients and 47 healthy controls, a two-sample t-test was performed on individual normalized regional homogeneity (ReHo) maps. Relationships between abnormal ReHo values and the Pittsburgh Sleep Quality Index (PSQI), the self-rating anxiety scale (SAS) and the self-rating depression scale (SDS) were investigated with Pearson correlation analysis. In PI patients, we found increased ReHo in the left insula, right anterior cingulate gyrus, bilateral precentral gyrus and left cuneus, as well as decreased ReHo in the right middle cingulate cortex and left fusiform (p < 0.05, AlphaSim-corrected). We also found a significant positive correlation between increased ReHo in the left insula and SAS scores, decreased ReHo in the right middle cingulated cortex and SDS, SAS scores as well as a negative correlation between increased ReHo in the right precentral gyrus and SDS scores (p < 0.05). Our study found abnormal spontaneous activities in multiple brain regions, especially in emotion-related areas in PI patients. Alterative activities in these regions might contribute to an understanding the intrinsic functional architecture of insomnia and its clinical features. (orig.)

  3. Insomnia management for ageing employees with job stress

    Directory of Open Access Journals (Sweden)

    Roja I.

    2014-01-01

    Full Text Available In Latvia, the number of aging employees suffering from sleep disorders caused by job stress and poor sleep hygiene is increasing. The non-pharmacologic and pharmacologic treatment is prescribed for these employees in the sleep management. The a