Doxepin had the strongest evidence of effectiveness for global and sleep outcomes among adults 55 years and older. Eszopiclone, zolpidem, and suvorexant had the strongest evidence of effectiveness in the general adult population for global and sleep outcomes. Most of these studies were of short duration and had a small sample size. There were 38 randomized controlled trials identified that evaluated pharmacologic therapies, including nonbenzodiazepine hypnotics (eszopiclone, zaleplon, zolpidem), an orexin receptor antagonist (suvorexant), melatonin agonists (prolonged-release melatonin, ramelteon), an antidepressant (doxepin), and a benzodiazepine hypnotic (temazepam). Potential addictive effects when combined with central nervous system depressants or sedating antihistamines Possible adverse effects in persons with severe sleep apneaĭrowsiness, nausea, upper respiratory tract infectionĬentral nervous system depressant effects, with impaired alertness and motor coordination that may persist the next day Potential impairment of activities requiring complete mental alertness after drug ingestionĭecreased testosterone and increased prolactin levels Somnolence, fatigue, headache, dizziness, worsened insomnia, nausea Sleep paralysis, hypnagogic or hypnopompic hallucinations, cataplexy-like symptoms Possible adverse effects in persons with severe lung disease or sleep apnea Possible profound sedation, respiratory depression, coma, and death with concomitant opioid use Worsening depression or suicidal thoughts in persons with primary depression Headache, drowsiness, dizziness, paresthesias, difficulty with coordinationĭrowsiness, dizziness, headache, nervousness, nauseaĪbnormal thinking, behavior changes, complex behaviors (including sleep-driving, hallucinations) Somnolence, headache, malaise, vertigo, dizziness, diarrhea Withdrawal symptoms if abrupt dose reduction or discontinuation Possible respiratory depression in persons with severe lung disease or sleep apnea Severe anaphylactic or anaphylactoid reactions Worsening depression or suicidal thoughtsįalls and severe injuries because of drowsiness Sleep-driving and other complex behaviors while not fully awake Increased central nervous system effects in older adults Somnolence, unpleasant taste in the mouth, headache, dizziness, dry mouth, rash, anxiety, hallucinations, respiratory infectionĬentral nervous system depressant effects and next-day psychomotor impairment Over-the-counter sleep medications and supplements Probably has no effect on other outcomes Probably has no effect on total sleep time Improves sleep onset latency, total sleep time, and sleep quality Improves sleep onset latency and total sleep time Data were insufficient to evaluate the effectiveness of benzodiazepines or over-the-counter sleep aids such as diphenhydramine, doxylamine, or melatonin. (SOR: A, based on consistent, good-quality patient-oriented evidence.) There was limited evidence for the long-term safety of pharmacotherapy for insomnia ( eTable A), although observational studies suggest possible associations with head injuries, cancer, and dementia. Food and Drug Administration–approved prescription drugs for insomnia, eszopiclone, zolpidem, and suvorexant improved some outcomes among the general adult population in primarily short-term studies of three months or less. (SOR: B, based on inconsistent or limited-quality patient-oriented evidence.) There was insufficient evidence to report on the adverse effects of CBT for insomnia. (Strength of Recommendation : A, based on consistent, good-quality patient-oriented evidence.) The effectiveness of CBT for insomnia was consistent across different delivery modes (i.e., in person as an individual or with a group, by telephone, through the web, or using a self-help book) and was sustained in the long term, which was defined as at least six months. Cognitive behavior therapy (CBT) for insomnia improves sleep outcomes in the general adult population.
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