Management of Insomnia Disorder [Entered Retrospectively]

Project Summary Title and Description

Title
Management of Insomnia Disorder [Entered Retrospectively]
Description
Objective. To assess the efficacy, comparative effectiveness, and harms of treatments for insomnia disorder in the general adult population and older adults. Data sources. Ovid MEDLINE®, the Cochrane Central Register of Controlled Trials, Embase®, and PsycINFO®SYCINFO bibliographic databases; hand searches of references of relevant studies. Review methods. Two investigators screened abstracts and full-text articles of identified references for eligibility. Eligible studies included systematic reviews, randomized controlled trials (RCTs), and long-term observational pharmacologic studies enrolling participants with insomnia disorder. We analyzed data for global outcomes (measures that assess both sleep and daytime functioning associated with sleep), sleep parameters, and harms. We assessed risk of bias for RCTs, extracted data, assessed quality of relevant systematic reviews, and evaluated strength of evidence for comparisons and outcomes. Pooled estimates were analyzed to assess the efficacy and comparative effectiveness of treatments. Results. We searched bibliographic databases through January 2015 for studies evaluating psychological, pharmacologic, and complementary, and alternative medicine interventions for insomnia disorder. We synthesized evidence from 181 unique studies (data from 128 unique RCTs and 3 systematic reviews that( synthesizeing data from 42 unique RCTs) and 12 observational studies. Sample sizes and enrollment criteria varied; most trials were short in duration. Outcome reporting and intervention effect sizes varied, and a large placebo response was often observed. Cognitive behavioral therapy for insomnia (CBT-I) improved global outcomes and nearly all sleep parameters in the general adult population, older adults, and adults with pain. We found insufficient evidence on adverse effects of these interventions. Evidence was less robust for psychological interventions other than CBT-I, but low -strength evidence shows that some interventions improve some sleep outcomes. Low- to moderate -strength evidence indicated that the nonbenzodiazepine hypnotics, eszopiclone and zolpidem, and the orexin receptor antagonist, suvorexant, improved short-term global and sleep outcomes in general adult populations. Doxepin improved sleep outcomes. The absolute mean effect was small. Evidence for benzodiazepine hypnotics, melatonin agonists, and antidepressants in general populations and for most pharmacologic interventions in older adults was generally insufficient. Evidence on adverse effects from RCT data was generally insufficient or low strength. Observational studies suggest that hypnotics may be associated with dementia, fractures, and major injury. Food and Drug Administration (FDA) labels warn about cognitive and behavioral changes, including driving impairment, and other harms, and advise lower doses reduction in for females and older/debilitated adults. Evidence on complementary and alternative medicine was insufficient. Evidence was insufficient to compare hypnotic medications within or across classes or versus CBT-I. Conclusions. CBT-I or medical therapy with eszopiclone, zolpidem, and suvorexant improve global and sleep outcomes for insomnia disorder. Clinical significance, applicability, comparative effectiveness, and long-term efficacy, especially among older adults, are less well known. Effect sizes vary, and a large placebo response is sometimes observed. Observational studies suggest an association of hypnotics with infrequent but serious, harms. FDA labels provide specific warnings and precautions for drugs approved for insomnia.
Attribution
N/A
Authors of Report
N/A
Methodology description
N/A
PROSPERO
N/A
DOI
10.7301/Z0PC308S
Notes
Web address not yet available. Data entered retrospectively. Excel files include basic study information, participant characteristics, and risk of bias assessments.
Funding Source
AHRQ

Key Questions

1. What are the efficacy and comparative effectiveness of treatments for insomnia disorder in adults? a) What are the efficacy and comparative effectiveness of treatments for insomnia disorder in specific subgroups of adults? b) What are the efficacy and comparative effectiveness of combined treatments (e.g., cognitive behavioral therapy and drug therapy) for the treatment of insomnia disorder in adults? c) What are the long-term efficacy and comparative effectiveness of treatments for insomnia disorder in adults?
2. What are the harms of treatments for insomnia disorder in adults? a) What are the harms of treatments for insomnia disorder in specific subgroups of adults? b) What are the harms of combined treatments (e.g., cognitive behavioral therapy and drug therapy) for insomnia disorder in adults? c) What are the long-term harms of treatments for insomnia disorder in adults?

Associated Extraction Forms

Associated Studies (each link opens a new tab)

TitleAuthorsYear
Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia.2007
Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia.2004
Trazodone improves the results of cognitive behaviour therapy of primary insomnia in non-depressed patients.2008
Mindfulness-based stress reduction for chronic insomnia in adults older than 75 years: a randomized, controlled, single-blind clinical trial.-- Not Found --
Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.2011
Comparison of sleep condition and sleep-related psychological activity after cognitive-behavior and pharmacological therapy for chronic insomnia.2006
Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations.2007
Psychological treatment of insomnia in hypnotic-dependant older adults.2008
Internet-based treatment for insomnia: a controlled evaluation.
A systematic review of valerian as a sleep aid: safe but not effective.2007
A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms.2013
A comparison between acupuncture versus zolpidem in the treatment of primary insomnia.2012
Efficacy and safety of ramelteon in Japanese adults with chronic insomnia: a randomized, double-blind, placebo-controlled study.2011
Self-help treatment for insomnia through television and book: a randomized trial.2009
Guided Internet-delivered cognitive behavioural treatment for insomnia: a randomized trial.2014
Logging on for better sleep: RCT of the effectiveness of online treatment for insomnia.2009
Cognitive-behavioral treatment for comorbid insomnia and osteoarthritis pain in primary care: the lifestyles randomized controlled trial.2013
Cognitive behavioral therapy for insomnia improves sleep and decreases pain in older adults with co-morbid insomnia and osteoarthritis.2009
Prolonged release melatonin in the treatment of primary insomnia: evaluation of the age cut-off for short- and long-term response.
Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety.2010
Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial.2006
Novel sublingual low-dose zolpidem tablet reduces latency to sleep onset following spontaneous middle-of-the-night awakening in insomnia in a randomized, double-blind, placebo-controlled, outpatient study.2013
Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia.2006
Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle-of-the-night awakening in insomnia.2014
Testing two types of self-help CBT-I for insomnia in older adults with arthritis or coronary artery disease.2011
A placebo-controlled test of cognitive-behavioral therapy for comorbid insomnia in older adults.
A computer device to deliver behavioral interventions for insomnia.2010
Efficacy of an Internet-based behavioral intervention for adults with insomnia.2009
Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study.2012
Effects of moderate aerobic exercise training on chronic primary insomnia.2011
Long-term, non-nightly administration of zolpidem in the treatment of patients with primary insomnia.2004
Comparative effectiveness of CBT interventions for co-morbid chronic pain & insomnia: a pilot study.2012
Chronic primary insomnia: efficacy of homeopathic simillimum.2010
Adverse effects of temazepam in older adults with chronic insomnia.2003
Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial.2005
Cognitive-behavior therapy for late-life insomnia.1993
Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial.2009
Self-help treatment for insomnia symptoms associated with chronic conditions in older adults: a randomized controlled trial.2012
Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness.2007
Who benefits from CBT for insomnia in primary care? Important patient selection and trial design lessons from longitudinal results of the Lifestyles trial.
Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial.2014
Self-help treatment for insomnia: bibliotherapy with and without professional guidance.1999
Efficacy and safety of Wuling capsule, a single herbal formula, in Chinese subjects with insomnia: a multicenter, randomized, double-blind, placebo-controlled trial.2013
Evaluation of a brief treatment program of cognitive behavior therapy for insomnia in older adults.
Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia.2009
Motivational support provided via email improves the effectiveness of internet-delivered self-help treatment for insomnia: a randomized trial.2013
Internet-delivered or mailed self-help treatment for insomnia?: a randomized waiting-list controlled trial.2012
Efficacy and safety of doxepin 6 mg in a four-week outpatient trial of elderly adults with chronic primary insomnia.2012
Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia.2010
Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: a 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study.2008
Efficacy and safety of doxepin 3 and 6 mg in a 35-day sleep laboratory trial in adults with chronic primary insomnia.2011
Cognitive-behavioral group therapy as an early intervention for insomnia: a randomized controlled trial.2005
Don't worry, be constructive: a randomized controlled feasibility study comparing behaviour therapy singly and combined with constructive worry for insomnia.2012
Cognitive-behavioral therapy for insomnia co-morbid with hearing impairment: a randomized controlled trial.2012
The efficacy of cognitive-behavioral therapy for insomnia in patients with chronic pain.2010
The durability of cognitive behavioral therapy for insomnia in patients with chronic pain.2012
Twenty minutes versus forty-five minutes morning bright light treatment on sleep onset insomnia in elderly subjects.2004
Effects of acupuncture with meridian acupoints and three Anmian acupoints on insomnia and related depression and anxiety state.2013
Cognitive behavior therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison.2004
Web- vs. telehealth-based delivery of cognitive behavioral therapy for insomnia: a randomized controlled trial.2014
The needle-rolling therapy for treatment of non-organic chronic insomnia in 90 cases.2009
Neurofeedback for insomnia: a pilot study of Z-score SMR and individualized protocols.2011
A randomized controlled trial of intensive sleep retraining (ISR): a brief conditioning treatment for chronic insomnia.2012
The effect of a homeopathic complex on psychophysiological onset insomnia in males: a randomized pilot study.-- Not Found --
A randomized, double-blind, placebo-controlled trial of eszopiclone for the treatment of insomnia in patients with chronic low back pain.2014
Mindfulness-based stress reduction versus pharmacotherapy for chronic primary insomnia: a randomized controlled clinical trial.-- Not Found --
Isoflavones decrease insomnia in postmenopause.2011
Zolpidem extended-release improves sleep and next-day symptoms in comorbid insomnia and generalized anxiety disorder.2009
A double-blind randomised controlled study of a brief intervention of bedtime restriction for adult patients with primary insomnia.2013
Scheduled bright light for treatment of insomnia in older adults.2009
Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial.
Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial.2009
Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.2007
Cognitive-behavioral therapy for insomnia: comparison of individual therapy, group therapy, and telephone consultations.
A self-help book is better than sleep hygiene advice for insomnia: a randomized controlled comparative study.2011
Manual-guided cognitive-behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial.2013
Acupuncture for insomnia.2012
Homeopathy for insomnia: summary of additional RCT published since systematic review.2010
Homeopathy for insomnia: a systematic review of research evidence.2010
An exploratory study on the effects of tele-neurofeedback and tele-biofeedback on objective and subjective sleep in patients with primary insomnia.2010
A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia.2010
Randomized controlled trial of telephone-delivered cognitive behavioral therapy for chronic insomnia.2013
Yoga decreases insomnia in postmenopausal women: a randomized clinical trial.2012
Hybrid cognitive-behaviour therapy for individuals with insomnia and chronic pain: a pilot randomised controlled trial.2012
A pilot randomized controlled trial of the effects of cognitive-behavioral therapy for insomnia on sleep and daytime functioning in college students.2014
Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia.2012
Zolpidem is not superior to temazepam with respect to rebound insomnia: a controlled study.2004
Paroxetine treatment of primary insomnia in older adults.2006
A randomized controlled trial of problem-solving therapy compared to cognitive therapy for the treatment of insomnia in adults.2013
A randomized controlled trial of mindfulness meditation for chronic insomnia.
The effect of support on internet-delivered treatment for insomnia: does baseline depression severity matter?2014
Efficacy of a behavioral self-help treatment with or without therapist guidance for co-morbid and primary insomnia--a randomized controlled trial.
Guided internet cognitive behavioral therapy for insomnia compared to a control treatment - A randomized trial.2015
Cognitive behavioral therapy vs. Tai Chi for late life insomnia and inflammatory risk: a randomized controlled comparative efficacy trial.2014
Weekly brief phone support in self-help cognitive behavioral therapy for insomnia disorder: Relevance to adherence and efficacy.2014
Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: a randomized controlled trial.2014
Effects of a brief behavioral treatment for late-life insomnia: preliminary findings.2006
Efficacy of acupuncture for primary insomnia: a randomized controlled clinical trial.
Acupuncture improves sleep in postmenopause in a randomized, double-blind, placebo-controlled study.2013
Simplified sleep restriction for insomnia in general practice: a randomised controlled trial.2015
Attribution, cognition and psychopathology in persistent insomnia disorder: outcome and mediation analysis from a randomized placebo-controlled trial of online cognitive behavioural therapy.2014
A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application.2012
Internet-vs. group-delivered cognitive behavior therapy for insomnia: A randomized controlled non-inferiority trial.2015
Efficacy of brief behavioral treatment for chronic insomnia in older adults.
Prefrontal hypoactivation and recovery in insomnia.2008
The effect of magnesium supplementation on primary insomnia in elderly: A double-blind placebo-controlled clinical trial.2012
Efficacy and safety of zolpidem administered as needed in primary insomnia: results of a double-blind, placebo-controlled study.2001
Zolpidem for persistent insomnia in SSRI-treated depressed patients.1999
A primary care "friendly" cognitive behavioral insomnia therapy2003
Cognitive Behavioral Therapy for Treatment of Chronic Primary InsomniaA Randomized Controlled Trial2001
Sleep latency is shortened during 4 weeks of treatment with zaleplon, a novel nonbenzodiazepine hypnotic. Zaleplon Clinical Study Group.1999
A controlled comparative investigation of psychological treatments for chronic sleep-onset insomnia1989
The clinical effectiveness of cognitive behaviour therapy for chronic insomnia: implementation and evaluation of a sleep clinic in general medical practice2001
Randomized Clinical Effectiveness Trial of Nurse-Administered Small-Group Cognitive Behavior Therapy for Persistent Insomnia in General Practice2007
Zaleplon improves sleep without producing rebound effects in outpatients with insomnia. Zaleplon Clinical Study Group.2000
Doxepin in the treatment of primary insomnia: a placebo-controlled, double-blind, polysomnographic study.2001
Suvorexant in Patients with Insomnia: Results from Two 3-Month Randomized Controlled Clinical Trials.2014
Multifactor behavioral treatment of chronic sleep-onset insomnia using stimulus control and the relaxation response. A preliminary study.1993
Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia.2003
Ramelteon for the treatment of insomnia in adults: a systematic review and meta-analysis.2014
Relaxation and sleep compression for late-life insomnia: a placebo-controlled trial.2001
Efficacy of behavioral versus triazolam treatment in persistent sleep-onset insomnia.1991
Comparative hypnotic effects of flurazepam, triazolam, and placebo: a long-term simultaneous nighttime and daytime study.1984
Psychological treatment for insomnia in the management of long-term hypnotic drug use: a pragmatic randomised controlled trial.2003
Behavioral and pharmacological therapies for late-life insomnia: a randomized controlled trial.1999
Stimulus control and imagery training in treating sleep-maintenance insomnia.1987
Behavioral and cognitive treatments of geriatric insomnia.1988
Behavioral treatment of insomnia in older adults: an open clinical trial comparing two interventions.
Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder.2008
Comparison of triazolam, flurazepam, and placebo as hypnotics in geriatric patients with insomnia.-- Not Found --
Psychophysiological insomnia: combined effects of pharmacotherapy and relaxation-based treatments.2000
A multicenter, placebo-controlled study evaluating zolpidem in the treatment of chronic insomnia.1994
Cognitive-behavioral therapy for insomnia in knee osteoarthritis: a randomized, double-blind, active placebo-controlled clinical trial.2015
Zolpidem "as needed" for the treatment of primary insomnia: a double-blind, placebo-controlled study.2002
Low Resistance Thought Induction Sleep-regulating Technique (TIP3-2) combined with medication for primary insomnia: a randomized controlled trial.2014
Electroacupuncture for primary insomnia: a randomized controlled trial.2009
Subjective Efficacy of Zolpidem in Outpatients with Chronic Insomnia: A Double-Blind Comparison with Placebo1997
Double-blind, placebo-controlled comparison of zolpidem, triazolam, and temazepam in elderly patients with insomnia1998
A double-blind study comparing the efficacy and safety of quazepam with flunitrazepam and placebo in patients with chronic insomnia1988

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