Medications and Drugs
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
Last Editorial Review: 4/18/2006
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.
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