Meta-analyses are mixed on whether ramelteon increases total sleep time. Ramelteon also improves sleep quality (SMD –0.074, 95% CI –0.13 to –0.02) and sleep efficiency. The clinical improvement in insomnia with ramelteon is small and of questionable benefit.Ramelteon is approved in the United States but was not approved in the European Union owing to concerns that it lacked effectiveness. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) noted that ramelteon had only been found to improve sleep onset and not other sleep outcomes, only one of three clinical trials actually found that it improved sleep onset, and that the improvement in sleep onset was too small to be clinically meaningful. The CHMP also noted that the long-term effectiveness of ramelteon had not been demonstrated.The American Academy of Sleep Medicines 2017 clinical practice guidelines recommended the use of ramelteon in the treatment of sleep-onset insomnia. It rated the recommendation as weak and the quality of evidence as very low but concluded that the potential benefits outweighed the potential harms. The guidelines found that ramelteon reduces sleep latency by 9 minutes (95% CI 6–12 minutes) but does not improve sleep quality. In contrast to ramelteon, the guidelines did not recommend the use of melatonin. Circadian rhythm sleep disorders
Melatonin receptor agonists like melatonin and tasimelteon are considered to be effective in regulating sleep–wake cycles and in the treatment of circadian rhythm sleep disorders like delayed sleep phase disorder.
Society and culture
Legal status
Ramelteon has no potential for abuse or drug dependence and is not a controlled substance. Research
Psychiatry
Ramelteon, along with other melatonin receptor agonists like melatonin, has been repurposed in clinical trials as an adjunctive treatment for acute manic episodes in subjects with bipolar disorder. Nonetheless, meta-analytic evidence is based on very few trials and does not allow supporting the use of melatonin receptor agonists as adjunctive options for mania in clinical practice, although the small sample size do not allow ruling out their beneficial effect. References
External links
"Ramelteon". Drug Information Portal. U.S. National Library of Medicine.