Objective To evaluate the effectiveness and safety of ramelteon for chronic insomnia in adults. Methods The following databases as CENTRAL, PubMed, EMbase, ISI, CNKI, CBMdisc, VIP and WanFang Data were searched from the date of their establishment to November 2010. The randomized controlled trials (RCTs) meeting the inclusion criteria were included. The data extraction and quality assessment were conducted according to the methods of Cochrane Reviewers’ Handbook recommend by The Cochrane Collaboration, and meta-analysis was performed with RevMan5.0 software. Results A total of 5 RCTs involving 1 772 patients were included. The results of meta-analyses showed that: a) Effectiveness: In the effectiveness, ramelteon was superior to placebo in latency to persistent sleep (MD=18.36, 95%CI 11.55 to 25.18, Plt;0.000 01), total sleep time (MD= –15.47, 95%CI –22.50 to –8.43, Plt;0.000 1), sleep efficiency (MD= –3.39, 95%CI –5.32 to –1.46, P=0.000 6), sleep quality (MD=0.14, 95%CI 0.03 to 0.25, P=0.01) after one week treatment and latency to persistent sleep (MD=13.02, 95%CI 6.01 to 20.03, P=0.000 3) except for wake after sleep onset (MD= –8.79, 95%CI –17.24 to –0.35, P=0.04) after one month treatment. b) Safety: significant differences were only found in the female prolactin (MD=5.50, 95%CI 2.02 to 8.98, P=0.002) and male free testosterone (MD=15.30, 95%CI 0.62 to 29.98, P=0.04) between the two groups, rather than in all the other hormones concentration, rebound insomnia, withdrawal syndrome, next-day residual effects and incidence rate of adverse reactions. Conclusion Ramelteon has marked effects on adults’ chronic insomnia after 1-week treatment, but its effect is not obvious after 1-month treatment. The adverse reactions are mostly the somnolence, rising of male free testosterone and female prolactin concentration.