The effects of ramelteon in a first-night model of transient insomnia
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 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.
Keywords: Melatonin receptor agonist, Insomnia, Polysomnography, Sleep environment, Latency to persistent sleep, Total sleep time
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PII: S1389-9457(08)00145-7
doi:10.1016/j.sleep.2008.04.010
© 2008 Elsevier B.V. All rights reserved.
