Important Safety Information about Rozerem^® (ramelteon)

Rozerem is approved for adults having trouble falling asleep.

Don’t take Rozerem if you’re taking LUVOX^® (fluvoxamine) or have severe liver problems. Avoid taking it with alcohol. Don’t drive or operate machinery until you know how you’ll react to Rozerem. Rozerem may affect testosterone and prolactin. Consult your doctor if you have concerns about a change in your period, libido, fertility, or if your insomnia doesn’t improve. Take Rozerem right before bed. Side effects may include drowsiness, fatigue, and dizziness.

You are encouraged to report negative side effects of prescription drugs to the U.S. Food and Drug Administration (FDA). Visit www.FDA.gov/medwatch, or call 1-800-FDA-1088.

For complete prescribing information, please visit www.rozerem.com or view the Rozerem Complete Prescribing Information.