The effects of ramelteon in a first-night model of transient insomnia.

Author(s): Zammit G, Schwartz H, Roth T, Wang-Weigand S, Sainati S, Zhang J

Affiliation(s): Clinilabs Sleep Disorder Institute, 423 West 55th Street, New York, NY 10019, USA.

Publication date & source: 2008-08-06, Sleep Med., [Epub ahead of print]

Publication type:

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 8mg, 16mg, 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 8mg treatment significantly reduced latency to persistent sleep compared with placebo (12.2min vs. 19.7min, P=0.004). Total sleep time was significantly increased with both ramelteon 8mg (436.8min, P=0.009) and ramelteon 16mg (433.1min, P=0.043) compared with placebo (419.7min). 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 8mg 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.