ramelteon (Rozerem)

What is Rozerem, and how does it work (mechanism of action)?

Ramelteon is an oral drug that promotes falling asleep and is used for treating insomnia. It acts by stimulating receptors for melatonin in the brain. Melatonin and its receptors control the circadian rhythm of the body which controls the sleep/wake cycle. Unlike many drugs used for treating insomnia, ramelteon is not addictive, and it is not a controlled substance. Ramelteon also does not cause withdrawal symptoms or rebound insomnia when it is stopped. Ramelteon was approved by the FDA in July 1995.

What brand names are available for Rozerem?


Is Rozerem available as a generic drug?


Do I need a prescription for Rozerem?


What are the side effects of Rozerem?

Side effects associated with ramelteon include:

Rare cases of severe allergic reactions involving swelling of the tongue and closure of the throat have been reported.

Other important side effects include:

What is the dosage for Rozerem?

The recommended dose of ramelteon is 8 mg taken 30 minutes before bedtime. Ramelteon should not be taken with or immediately after a high fat meal because fat increases its absorption from the intestine.


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Which drugs or supplements interact with Rozerem?

Doxepin (Sinequan, Adapin), donepezil (Aricept), fluvoxamine (Luvox, Luvox CR), ketoconazole (Nizoral, Extina, Xolegel, Kuric), and fluconazole (Sporanox) increase blood levels of ramelteon, possibly increasing side effects of ramelteon. Rifampin may decrease blood levels of ramelteon, possibly reducing the effect of ramelteon. Alcohol increases the sedative effects ramelteon.

Is Rozerem safe to take if I'm pregnant or breastfeeding?

Ramelteon has not been evaluated in pregnant women. Animal studies show that it may cause harm. Therefore, ramelteon should not be used in pregnant women unless it is absolutely necessary.

Ramelteon has not been evaluated in nursing mothers.

What else should I know about Rozerem?

What preparations of Rozerem are available?

How should I keep Rozerem stored?

Ramelteon should be store at room temperature, between 15 C - 30 C (59 F - 86 F).


Ramelteon (Rozerem) is a medication prescribed for improving sleep in individuals who have insomnia that involves difficulty falling asleep. Side effects, drug interactions, warnings and precautions, and pregnancy safety should be reviewed prior to taking this medication.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

See more info: Rozerem on RxList
Medically reviewed by John P. Cunha, DO, FACOEP; Board Certified Emergency Medicine


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