ramelteon, Rozerem (cont.)

Pharmacy Author:
Medical and Pharmacy Editor:

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