ramelteon, Rozerem

Pharmacy Author:
Medical and Pharmacy Editor:

GENERIC NAME: ramelteon

BRAND NAME: Rozerem

DRUG CLASS AND MECHANISM: 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.

PRESCRIPTION: Yes.

GENERIC AVAILABLE: No.

PREPARATIONS:

Tablets: 8 mg

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

PRESCRIBED FOR: Ramelteon is used for improving sleep in individuals who have insomnia that involves difficulty falling asleep.

DOSING: 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.

DRUG INTERACTIONS: 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.

PREGNANCY: 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.

NURSING MOTHERS: Ramelteon has not been evaluated in nursing mothers.

SIDE EFFECTS: Side effects associated with ramelteon include headache, drowsiness, fatigue, dizziness, nausea, worsening of insomnia, and diarrhea. Rare cases of severe allergic reactions involving swelling of the tongue and closure of the throat have been reported. Abnormal thinking, behavior changes, depression, suicidal thoughts, manic episodes, and sleep driving have also been associated with ramelteon.

Reference: FDA Prescribing Information


Last Editorial Review: 3/19/2012




Report Problems to the Food and Drug Administration

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.

Pill Finder Tool

Need help identifying pills and medications?
Use the pill identifier tool on RxList.


Back to Medications Index