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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® 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 synthesize 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.