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  • Title: The effects of ramelteon in a first-night model of transient insomnia.
    Author: Zammit G, Schwartz H, Roth T, Wang-Weigand S, Sainati S, Zhang J.
    Journal: Sleep Med; 2009 Jan; 10(1):55-9. PubMed ID: 18691937.
    Abstract:
    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.
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