title: Ramelteon for the treatment of insomnia in adults: a systematic review and meta-analysis.
abstract: Ramelteon is the first selective melatonin receptor agonist and currently is approved in the United States and Japan for the treatment of insomnia. Our meta-analysis assessed the efficacy and safety of ramelteon for the treatment of insomnia in adults. We included both published and unpublished data from randomized placebo-controlled trials evaluating the efficacy of ramelteon in adults with insomnia in the analysis. Our primary outcomes were sleep quality, subjective sleep latency (sSL), and subjective total sleep time (sTST). Secondary outcomes included latency to persistent sleep (LPS), total sleep time (TST), sleep efficiency (SE), proportion of rapid eye movement (REM) sleep, wakefulness after sleep onset (WASO), subjective WASO, number of nighttime awakenings (NAW), subjective NAW, and adverse events. Thirteen trials involving 5812 patients with insomnia or insomnia symptoms with a mean study duration of 38 days were pooled. Ramelteon was associated with reduced sSL (weighted mean difference [WMD], -4.30 min [95% confidence interval {CI}, -7.01 to -1.58]) and improved sleep quality (standardized mean differences, -0.074 [95% CI, -0.13 to -0.02]) but was not associated with increased sTST. Ramelteon also was associated with improvement in LPS, SE, and TST. The only significant adverse event was somnolence. Short-term use of ramelteon was associated with improvement in some sleep parameters in patients with insomnia, but its clinical impact is small. Long-term trials are needed before solid conclusions can be established.
authors.affiliation: Department of General Medicine, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan. Electronic address: nrk40448@nifty.com.
authors.forename: Akira
authors.initials: A
authors.lastname: Kuriyama
authors.affiliation: Department of Gastroenterological Surgery, Cancer Institute Ariake Hospital, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan.
authors.forename: Michitaka
authors.initials: M
authors.lastname: Honda
authors.affiliation: Department of Endocrinology, Tenri Hospital, 200 Mishima-cho, Tenri, Nara 632-8552, Japan.
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Hayashino
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007192:Indenes / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D044094:Receptors, Melatonin / Q000819:agonists*; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007192:Indenes; D044094:Receptors, Melatonin; C495910:ramelteon
keywords: Insomnia; Melatonin receptor agonist; Meta-analysis; Primary insomnia; Ramelteon; Systematic review