The effects of ramelteon in a first-night model of transient insomnia
Received 2 January 2008; received in revised form 7 April 2008; accepted 9 April 2008.
Abstract
Objective
To evaluate the efficacy and safety of ramelteon, a highly selective MT1/MT2 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.
ABSTRACT