Content area
Full text
Clinical Question
How safe and effective are melatonin receptor agonists for treating insomnia in older adults?
Evidence-Based Answer
Melatonin preparations reduce sleep-onset latency, increase total sleep time, and slightly improve sleep efficiency. (Strength of Recommendation [SOR]: B, based on meta-analysis of primarily small randomized crossover trials.) Prolonged-release melatonin reduces sleep-onset latency in older adults and has rates of adverse effects similar to those of placebo. (SOR: B, based on randomized controlled trials [RCTs] from a single research team.) Ramelteon (Rozerem; a melatonin receptor agonist) also reduces sleep-onset latency and may increase total sleep time. (SOR: B, based on large RCTs from a single research team.) Ramelteon use is not associated with severe traumatic accidents (e.g., falls, head injuries, motor vehicle crashes). (SOR: B, based on a retrospective cohort study.)
Evidence Summary
MELATONIN
A systematic review and meta-analysis included 15 primarily randomized crossover trials (N = 284) using objective measures to assess the effect of melatonin on sleep.1 Healthy young adults (six trials; n = 71) and adults older than 50 years (seven trials; n = 195) with insomnia comprised most of the participants. Eleven trials used oral immediate-release melatonin (0.1 to 80 mg nightly, with most patients receiving 1 to 5 mg nightly), and four used prolonged-release melatonin (0.5 to 2.5 mg nightly). Overall, melatonin treatment reduced sleep-onset latency (mean difference [MD] = −7.5 minutes; 95% CI, −9.9 to −5.2), increased total sleep time (MD = 12.8 minutes; 95% CI, 2.9 to 22.8), and improved sleep efficiency (MD = 2%; 95% CI, 0.2% to 4.2%) compared with placebo. Authors performed no subanalyses of older adults or various types of melatonin and did not address possible adverse effects. Most studies were crossover trials, enrolled fewer than 30 patients, and...