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SLEEP: Rozerem (ramelteon) Found Safe and Effective In Transient Insomnia

Michael Smith
Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of Pennsylvania School of Medicine. | June 21, 2006
SALT LAKE CITY — Rozerem (ramelteon), a melatonin agonist, was found both safe and effective in a laboratory model of transient insomnia.

MedPage Today Action Points
    • Explain to interested patients that this study suggests that Rozerem (ramelteon), approved for the treatment of insomnia, can be taken without residual effects to cope with occasional difficulty falling asleep.

    • This study was published as an abstract and presented orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.

SALT LAKE CITY, June 21 — Rozerem (ramelteon), a melatonin(Drug information on melatonin) agonist approved a year ago as an unscheduled agent for insomnia, was found both safe and effective in a laboratory model of transient insomnia, a New York researcher said here.

The medication reduced the time it took for participants to fall asleep, increased the quality of sleep, and had no residual psychomotor or memory effects the following day, said Gary Zammit, Ph.D., of St. Luke's-Roosevelt Hospital in New York.

The finding is valuable because it gives physicians and patients a medication that can be taken on an unscheduled basis to cope with occasional insomnia, Dr. Zammit reported in a poster at Sleep 2006, the joint meeting of the Sleep Research Society and the American Academy of Sleep Medicine.

Dr. Zammit and colleagues enrolled 289 healthy adults in a randomized, placebo-controlled parallel-group study of two different doses of Rozerem, 8 mg and 16 mg. The study was supported by Takeda Pharmaceuticals of Lincolnshire, Ill., the developer of Rozerem, a melatonin agonist that binds to the MT1 and MT2 receptors in the brain.

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