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Quick Facts About Rozerem - Ramelteon


Updated August 16, 2011

by Kimberly Read

  • Rozerem –- generic name ramelteon -– is a hypnotic sedative.

  • Rozerem is approved by the American Food and Drug Administration (FDA) for the treatment of insomnia. In particular, it is prescribed for individuals who have trouble falling asleep.

  • Rozerem is a melatonin receptor agonist, the first in a new class of drugs. This means that it mimics the activity of the body’s naturally occurring melatonin, a hormone that controls sleep and wake cycles.

  • As with other hypnotics, Rozerem may induce sleep activities such as eating, driving, making telephone calls, or walking without the person having any memory the next morning of having done these things. If this occurs, it should be reported to your doctor right away.

  • The most common side effects are somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.

  • Rozerem should not be taken with Luvox (fluvoxamine).

  • Rozerem should be used with caution in those with liver problems.

  • This drug has not been tested or approved for the treatment of children or adolescents under the age of 18.


Harvard Health Publications. (2007, October). Improving Sleep: A Guide to a Good Night's Rest.

FDA. (2005, August 30). Patient Information Sheet: Ramelteon Tablets (marketed as Rozerem).

Takeda Pharmaceuticals North America, Inc. (2008). Rozerem.

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