OBJECTIVE: To evaluate the efficacy and safety of ramelteon, a highly selective MT(1)/MT(2) melatonin receptor agonist, for the treatment of transient insomnia in adults. METHODS: In a randomized, double-blind, placebo-controlled, multi-center study, 289 adults naive to a sleep laboratory environment were randomized to receive a single nighttime dose of ramelteon 8 mg, 16 mg, or placebo. The primary variable was latency to persistent sleep measured by polysomnography. Additional objective and subjective sleep parameters as well as next-morning residual effects were assessed. RESULTS: Ramelteon 8 mg treatment significantly reduced latency to persistent sleep compared with placebo (12.2 min vs. 19.7 min, P=0.004). Total sleep time was significantly increased with both ramelteon 8 mg (436.8 min, P=0.009) and ramelteon 16 mg (433.1 min, P=0.043) compared with placebo (419.7 min). Ramelteon did not alter sleep architecture, and no significant next-morning residual effects were detected. The incidence of adverse events was similar for the ramelteon and placebo groups and most were considered mild or moderate. CONCLUSION: Ramelteon 8 mg significantly decreased latency to persistent sleep and increased total sleep time, with no significant next-morning psychomotor, memory, or cognitive effects in this first-night model of transient insomnia.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of ramelteon, a highly selective MT(1)/MT(2) melatonin receptor agonist, for the treatment of transient insomnia in adults. METHODS: In a randomized, double-blind, placebo-controlled, multi-center study, 289 adults naive to a sleep laboratory environment were randomized to receive a single nighttime dose of ramelteon 8 mg, 16 mg, or placebo. The primary variable was latency to persistent sleep measured by polysomnography. Additional objective and subjective sleep parameters as well as next-morning residual effects were assessed. RESULTS:Ramelteon 8 mg treatment significantly reduced latency to persistent sleep compared with placebo (12.2 min vs. 19.7 min, P=0.004). Total sleep time was significantly increased with both ramelteon 8 mg (436.8 min, P=0.009) and ramelteon 16 mg (433.1 min, P=0.043) compared with placebo (419.7 min). Ramelteon did not alter sleep architecture, and no significant next-morning residual effects were detected. The incidence of adverse events was similar for the ramelteon and placebo groups and most were considered mild or moderate. CONCLUSION:Ramelteon 8 mg significantly decreased latency to persistent sleep and increased total sleep time, with no significant next-morning psychomotor, memory, or cognitive effects in this first-night model of transient insomnia.
Authors: Andrew D Krystal; Gary K Zammit; James K Wyatt; Stuart F Quan; Jack D Edinger; David P White; Richard P Chiacchierini; Atul Malhotra Journal: J Clin Sleep Med Date: 2010-08-15 Impact factor: 4.062
Authors: Rachel E Fargason; Karen Gamble; Kristin T Avis; Rachel C Besing; Cherry W Jackson; Marshall E Cates; Roberta May Journal: Psychopharmacol Bull Date: 2011-05-15
Authors: Monique A J Mets; Juna M de Vries; Lieke M de Senerpont Domis; Edmund R Volkerts; Berend Olivier; Joris C Verster Journal: Sleep Date: 2011-10-01 Impact factor: 5.849
Authors: Seithikurippu R Pandi-Perumal; D Warren Spence; Joris C Verster; Venkatramanujam Srinivasan; Gregory M Brown; Daniel P Cardinali; Rüdiger Hardeland Journal: J Cent Nerv Syst Dis Date: 2011-04-12