Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.

INTRODUCTION: The purpose of this systematic review is to provide supporting evidence for a clinical practice guideline on the use of behavioral and psychological treatments for chronic insomnia disorder in adult populations. METHODS: The American Academy of Sleep Medicine commissioned a task force of 9 experts in sleep medicine and sleep psychology. A systematic review was conducted to identify randomized controlled trials that addressed behavioral and psychological interventions for the treatment of chronic insomnia disorder in adults. Statistical analyses were performed to determine if the treatments produced clinically significant improvements in a range of critical and important outcomes. Finally, the Grading of Recommendations Assessment, Development, and Evaluation process was used to evaluate the evidence for making specific treatment recommendations. RESULTS: The literature search identified 1,244 studies; 124 studies met the inclusion criteria, and 89 studies provided data suitable for statistical analyses. Evidence for the following interventions is presented in this review: cognitive-behavioral therapy for insomnia, brief therapies for insomnia, stimulus control, sleep restriction therapy, relaxation training, sleep hygiene, biofeedback, paradoxical intention, intensive sleep retraining, and mindfulness. This review provides a detailed summary of the evidence along with the quality of evidence, the balance of benefits vs harms, patient values and preferences, and resource use considerations.

Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline.

INTRODUCTION: This guideline establishes clinical practice recommendations for the use of behavioral and psychological treatments for chronic insomnia disorder in adults. METHODS: The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine and sleep psychology to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. The task force evaluated a summary of the relevant literature and the quality of evidence, the balance of clinically relevant benefits and harms, patient values and preferences, and resource use considerations that underpin the recommendations. The AASM Board of Directors approved the final recommendations. RECOMMENDATIONS: The following recommendations are intended as a guide for clinicians in choosing a specific behavioral and psychological therapy for the treatment of chronic insomnia disorder in adult patients. Each recommendation statement is assigned a strength ("strong" or "conditional"). A "strong" recommendation (ie, "We recommend…") is one that clinicians should follow under most circumstances. A "conditional" recommendation is one that requires that the clinician use clinical knowledge and experience, and to strongly consider the patient's values and preferences to determine the best course of action. 1. We recommend that clinicians use multicomponent cognitive behavioral therapy for insomnia for the treatment of chronic insomnia disorder in adults. (STRONG). 2. We suggest that clinicians use multicomponent brief therapies for insomnia for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 3. We suggest that clinicians use stimulus control as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 4. We suggest that clinicians use sleep restriction therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 5. We suggest that clinicians use relaxation therapy as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL). 6. We suggest that clinicians not use sleep hygiene as a single-component therapy for the treatment of chronic insomnia disorder in adults. (CONDITIONAL).

Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.

INTRODUCTION: The purpose of this guideline is to establish clinical practice recommendations for the pharmacologic treatment of chronic insomnia in adults, when such treatment is clinically indicated. Unlike previous meta-analyses, which focused on broad classes of drugs, this guideline focuses on individual drugs commonly used to treat insomnia. It includes drugs that are FDA-approved for the treatment of insomnia, as well as several drugs commonly used to treat insomnia without an FDA indication for this condition. This guideline should be used in conjunction with other AASM guidelines on the evaluation and treatment of chronic insomnia in adults. METHODS: The American Academy of Sleep Medicine commissioned a task force of four experts in sleep medicine. A systematic review was conducted to identify randomized controlled trials, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence. The task force developed recommendations and assigned strengths based on the quality of evidence, the balance of benefits and harms, and patient values and preferences. Literature reviews are provided for those pharmacologic agents for which sufficient evidence was available to establish recommendations. The AASM Board of Directors approved the final recommendations. RECOMMENDATIONS: The following recommendations are intended as a guideline for clinicians in choosing a specific pharmacological agent for treatment of chronic insomnia in adults, when such treatment is indicated. Under GRADE, a STRONG recommendation is one that clinicians should, under most circumstances, follow. A WEAK recommendation reflects a lower degree of certainty in the outcome and appropriateness of the patient-care strategy for all patients, but should not be construed as an indication of ineffectiveness. GRADE recommendation strengths do not refer to the magnitude of treatment effects in a particular patient, but rather, to the strength of evidence in published data. Downgrading the quality of evidence for these treatments is predictable in GRADE, due to the funding source for most pharmacological clinical trials and the attendant risk of publication bias; the relatively small number of eligible trials for each individual agent; and the observed heterogeneity in the data. The ultimate judgment regarding propriety of any specific care must be made by the clinician in light of the individual circumstances presented by the patient, available diagnostic tools, accessible treatment options, and resources. We suggest that clinicians use suvorexant as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians use eszopiclone as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians use zaleplon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians use zolpidem as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians use triazolam as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians use temazepam as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians use ramelteon as a treatment for sleep onset insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians use doxepin as a treatment for sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians not use trazodone as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians not use tiagabine as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians not use diphenhydramine as a treatment for sleep onset and sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians not use melatonin as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians not use tryptophan as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK). We suggest that clinicians not use valerian as a treatment for sleep onset or sleep maintenance insomnia (versus no treatment) in adults. (WEAK).

International classification of sleep disorders-third edition: highlights and modifications.

The recently released third edition of the International Classification of Sleep Disorders (ICSD) is a fully revised version of the American Academy of Sleep Medicine's manual of sleep disorders nosology, published in cooperation with international sleep societies. It is the key reference work for the diagnosis of sleep disorders. The ICSD-3 is built on the same basic outline as the ICSD-2, identifying seven major categories that include insomnia disorders, sleep-related breathing disorders, central disorders of hypersomnolence, circadian rhythm sleep-wake disorders, sleep-related movement disorders, parasomnias, and other sleep disorders. Significant modifications have been made to the nosology of insomnia, narcolepsy, and parasomnias. Major features and changes of the manual are reviewed in this article. The rationales for these changes are also discussed.

Development and growth of a large multispecialty certification examination: sleep medicine certification--results of the first three examinations.

This paper summarizes the results of the first three examinations (2007, 2009, and 2011) of the Sleep Medicine Certification Examination, administered by its six sponsoring American Board of Medical Specialty Boards. There were 2,913 candidates who took the 2011 examination through one of three pathways-self-attested practice experience, previous certification by the American Board of Sleep Medicine, or formal Sleep Medicine fellowship training. The 2011 exam was the last administration in which candidates who had not previously been admitted could take it without completion of formal Sleep Medicine fellowship training. As expected, the number of candidates admitted to the 2011 examination through the practice experience pathway increased, and the overall scores of these candidates were on average lower than the other candidates. Consequently, the pass rate for all first takers of the 2011 examination (65%) was lower than that observed from the 2009 examination (78%) and the 2007 examination (73%). For each administration, candidates admitted through the fellowship training pathway scored the highest; over 90% of them passed the 2011 and 2009 examinations.

Update on sleep and psychiatric disorders.

Current data demonstrate a high rate of comorbidity between sleep disorders and various psychiatric illnesses, especially mood and anxiety disorders. The disturbance of sleep quality and continuity that is associated with many sleep disorders predisposes to the development or exacerbation of psychological distress and mental illness. Likewise, the presence of psychiatric illness may complicate the diagnosis and treatment of sleep disorders. This focused review examines the literature concerning the interaction between major International Classification of Sleep Disorders, 2nd edition, diagnoses and psychiatric conditions with respect to sleep findings in various psychiatric conditions, psychiatric comorbidity in sleep disorders, and reciprocal interactions, including treatment effects. The data not only underscore the high frequency of psychopathology and psychological distress in sleep disorders, and vice versa, but also suggest that combined treatment of both the mental disorder and the sleep disorder should become the standard for effective therapy for all patients.

Development and results of the first ABMS subspecialty Certification Examination in Sleep Medicine.

In November 2007, the first Certification Examination in Sleep Medicine was administered to 1,882 candidates under the cosponsorship of five member boards of the American Board of Medical Specialties (ABMS)--the American Board of Internal Medicine, the American Board of Family Medicine, the American Board of Otolaryngology, the American Board of Pediatrics, and the American Board of Psychiatry and Neurology. The pass rate was 73%. This paper chronicles the history of a certification examination in Sleep Medicine and the development of this new ABMS examination.

Sleep and cancer: recent developments.

During the past decade, the critical role of sleep in health and disease has been underscored by research that further defines the relationship between sleep and myriad physiologic and psychological functions as well as quality of life. For many years, there was little exploration of the significance of sleep and sleep disorders in cancer patients; however, the past decade has seen a steady growth of inquiry in this area. These investigations have demonstrated the high frequency and significance of sleep disturbance as a symptom in cancer patients. They have also explored the complex interaction between sleep and other common cancer symptoms, most notably fatigue, depression, and pain, and have identified risk factors associated with the development of sleep problems in this population. Although treatment studies lag behind, reports of effective psychological and behavioral interventions for insomnia in cancer patients are increasing. Several studies are addressing pharmacotherapeutic intervention for hot flashes as a potential source of sleep disturbance. Other sleep disorders, most notably obstructive sleep apnea, also occur with some regularity in cancer patients.

Efficacy and clinical safety of ramelteon: an evidence-based review.

Ramelteon is a novel hypnotic compound that is FDA-approved for the treatment of sleep-onset difficulty. It is a melatonin 1/2 receptor agonist with rapid absorption, extensive first-pass metabolism and an elimination half-life of just over 1h. Clinical efficacy data indicate moderate efficacy in reduction of sleep latency in adults of all ages with chronic insomnia, with estimated effect sizes roughly comparable to other standard hypnotic agents. Objective studies show minimal increases in total sleep time and no significant impact on wake after sleep-onset or sleep-stage distribution. Subjective reports demonstrate comparable, if slightly smaller, improvements. The recommended dosage is 8mg but studies suggest a flat response across dosage ranges from 4 to 32mg. Safety data indicate no evidence of clinically significant next-day performance effects and a reasonably low side effect profile. Animal studies, and a single human study suggest low abuse potential. Single-blind run-out from clinical trials have demonstrated no evidence of rebound insomnia.

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

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

The Dartmouth sleep knowledge and attitude survey: development and validation.

OBJECTIVES: To construct and validate an instrument for the purpose of assessing effectiveness of curriculum development and educational interventions in sleep medicine. BACKGROUND: Medical school and graduate medical curricula have historically contained quite limited instruction in sleep physiology and sleep medicine. Recent initiatives, particularly the Sleep Academic Award program, have attempted to address this issue through support of programs designed to develop educational resources and implement curriculum change. Effective measures for assessment of educational outcome are an essential component of these interventions. METHODS: A panel of sleep experts, other medical professionals, and education consultants developed a knowledge and attitude survey, designed to address a broad range of topics in sleep physiology and medicine. The instrument was modified in response to pilot testing, and a final 24-item survey has been administered to two cohorts of college undergraduates before and immediately following a ten-week course of instruction and to a single cohort of first-year medical students. A group of sleep medicine experts served as the comparison population. Results were analyzed for item difficulty, item discrimination, and instructional sensitivity. RESULTS: Analyses of item difficulty, item discrimination, and instructional sensitivity were in line with acceptable norms for criterion-referenced tests. There was evidence of discriminative validity, as shown by scores on the measure and acknowledged expertise. CONCLUSION: This instrument demonstrates both logical and empirical evidence of validity and may serve as a useful tool in assessing outcome of educational interventions in sleep medicine.

Insomnia.

Effective management of insomnia begins with recognition and adequate assessment. Family doctors and other health care providers such as practice nurses and psychologists should routinely enquire about sleep habits as a component of overall health assessment. Identification and treatment of primary psychiatric disorders, medical conditions, circadian disorders, or specific physiological sleep disorders--eg, sleep apnoea and periodic limb movement disorder--are essential steps in management of insomnia. Conditioned aspects of insomnia can be primary (psychophysiological insomnia) or may complicate sleep disturbance owing to other causes. Approved hypnotic drugs have clearly been shown to improve subjective and objective sleep measures in various short-term situations. Despite widespread use of standard hypnotics and sedating antidepressants for chronic insomnia, their role for this indication still remains to be further defined by research evidence. Non-pharmacological treatments, particularly stimulus control and sleep restriction, are effective for conditioned aspects of insomnia and are associated with durable long-term improvement in sleep.

Neuropsychological impairment and quality of life in obstructive sleep apnea.

Although clinical experience has suggested for more than two decades that OSA is associated with impairment of cognition, emotional state, and quality of life and that treatment with nasal CPAP produces significant improvements in these areas, sound empirical evidence to support this view, especially regarding treatment outcome, has been lacking. More recent investigations have begun to provide this support from randomized, adequately controlled studies. These assessments suggest that some degree of cognitive dysfunction is associated with OSA. The effects are most apparent in the severe cases, whereas results in mild cases are more equivocal. Reported impairments include global intellectual dysfunction and deficits in vigilance, alertness, concentration, short- and long-term memory, and executive and motor function. Considerable discrepancy exists across studies with respect to type and degree of dysfunction, however. Disturbances in general intellectual function and executive function show strongest correlations with measures of hypoxemia. Not unexpectedly, alterations in vigilance, alertness, and, to some extent, memory seem to correlate more with measures of sleep disruption. Although many inadequately controlled investigations have demonstrated reversibility of most or all of these deficits with effective treatment, more recent placebo-controlled studies have raised doubts regarding whether the observed changes are truly a function of treatment. This issue requires further systematic exploration with adequate controls and step-wise analysis of treatment duration effects. A similar set of considerations exists with respect to the relationship between psychological disturbance, primarily depression, and OSA. Although several studies suggest significant depression in these patients, the results are mixed. Placebo-controlled treatment trials fail to demonstrate consistently a difference in mood improvement between active treatment groups and controls, although several methodologic considerations suggest that these results should be interpreted with caution. Numerous investigations leave little doubt about the issue of quality of life impairment among persons with OSA. Further characterization of impairment, particularly in areas specific to this population, will provide clearer understanding of the problem. Preliminary investigations of treatment response in controlled studies indicate significantly greater improvement of quality of life in response to CPAP. Although patients with OSA commonly report disturbances in cognitive and psychological function and general quality of life, the increased rates of obesity, hypertension, diabetes, cardiovascular disease, medication use, and related psychosocial complications present a host of potential etiologies that might explain the impairments noted. There can be little doubt that these covariants do, in some cases, contribute to neuropsychological dysfunctions. It is essential that future studies continue to define those disturbances that are specific to OSA, the relationship between levels of severity and impairment, the role of treatment in reversing these dysfunctions, and the correlation between test results and significant day-to-day social and occupational functional impairment.

Cardiovascular abnormalities in sleep-disordered breathing.

The role of sleep-disordered breathing (SDB) in the development of persistent daytime pulmonary hypertension (PH) and cor pulmonale is controversial and has not been extensively studied. In this review we discuss the physiological changes that occur during SDB in the cardiovascular system, as well as review the most recent literature examining the relationship between SDB and PH/cor pulmonale. The literature suggests that much of the PH and right heart dysfunction seen in SDB is related to concurrent obesity and underlying lung disease, although it does appear that isolated SDB (in the form of obstructive sleep apnea) may be responsible for a small but significant degree of PH. The clinical consequences of this, however, remain unclear.