Sleep Medicine
Volume 10, Issue 1 , Pages 55-59, January 2009

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

  • Gary Zammit

      Affiliations

    • Clinilabs Sleep Disorder Institute, 423 West 55th Street, New York, NY 10019, USA
    • Corresponding Author InformationCorresponding author. Tel.: +1 212 994 5100; fax: +1 212 994 5101.
    • ,
  • Howard Schwartz

      Affiliations

    • Miami Research Associates, 6141 Sunset Drive, Ste. 301, Miami, FL 33143, USA
    • ,
  • Thomas Roth

      Affiliations

    • Henry Ford Hospital, Sleep Disorders and Research Center, 2799 West Grand Boulevard, CFP-3 Detroit, MI 48202, USA
    • ,
  • Sherry Wang-Weigand

      Affiliations

    • Takeda Global Research and Development Center, 1 Takeda Parkway, Deerfield, IL 60015, USA
    • ,
  • Steve Sainati

      Affiliations

    • Takeda Global Research and Development Center, 1 Takeda Parkway, Deerfield, IL 60015, USA
    • ,
  • Jeff Zhang

      Affiliations

    • Takeda Global Research and Development Center, 1 Takeda Parkway, Deerfield, IL 60015, USA

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.

Keywords: Melatonin receptor agonist, Insomnia, Polysomnography, Sleep environment, Latency to persistent sleep, Total sleep time

To access this article, please choose from the options below

Login to an existing account or Register a new account.

  • Purchase this article for 31.50 USD (You must login/register to purchase this article)

    Online access for 24 hours. The PDF version can be downloaded as your permanent record.

  • Subscribe to this title

    Get unlimited online access to this article and all other articles in this title 24/7 for one year.

  • Claim access now

    For current subscribers with Society Membership or Account Number.

  • Visit SciVerse ScienceDirect to see if you have access via your institution.
 

PII: S1389-9457(08)00145-7

doi:10.1016/j.sleep.2008.04.010

Sleep Medicine
Volume 10, Issue 1 , Pages 55-59, January 2009

Article Tools