![]() 6 The 8-mg ramelteon dose reduced subjective sleep-onset latency at one week (MD = −15.7 minutes P =. A subgroup analysis of the study evaluated 8-mg ramelteon in 327 patients (mean age = 73 years) with subjective sleep-onset latency greater than 60 minutes. Presumed drug-related adverse effects occurred in 11% of patients taking 4-mg ramelteon, 5% of those taking 8-mg ramelteon, and 7% of those taking placebo (no P value given). There was a small increase in total sleep time at week 1 with 4 mg (MD = 10.7 minutes P =. 008) and five weeks (MD = −12.9 minutes P <. With 8-mg ramelteon, sleep-onset latency also decreased at one week (MD = −8.3 minutes P =. 008) and five weeks (MD = −7.2 minutes P =. 5 With 4-mg ramelteon, sleep-onset latency decreased at one week (MD = −8.3 minutes P =. In the largest trial, researchers randomized 829 patients 64 to 93 years of age (mean age = 72 years) with primary insomnia (baseline sleep-onset latency of at least 45 minutes) to ramelteon in a dosage of 4 mg or 8 mg or placebo for five weeks, followed by a one-week wash-out period. Three industry-sponsored trials evaluated the melatonin receptor agonist, ramelteon, for treatment of insomnia in older adults. Most studies were crossover trials, enrolled fewer than 30 patients, and gave medication for two weeks or less. Authors performed no subanalyses of older adults or various types of melatonin and did not address possible adverse effects. ![]() Overall, melatonin treatment reduced sleep-onset latency (mean difference = −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. 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). 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. This story was provided by MyHealthNewsDaily, a sister site to LiveScience.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.
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