Pharmacy Editor: Jay W. Marks, MD

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 that, in turn, 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: Store at room temperature, between 15-30°C (59-86°F).

PRESCRIBED FOR: Ramelteon is used for improving sleep in individuals who have 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: Fluvoxamine, ketoconazole and fluconazole 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.

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, diarrhea and depression.

Reference: FDA Prescribing Information