What assures me about my sleep aid is that it is non–habit-forming, it won't leave me feeling groggy the next day,* it works with my body's internal clock, it is gentle, so I won't feel sedated, and it is not likely to affect middle-of-the-night balance.**

Indication

Rozerem is approved for adults having trouble falling asleep.

Important Safety Information

If you have an allergic reaction, such as swelling of the tongue or throat, trouble breathing, and nausea and vomiting, contact your doctor immediately, as an airway obstruction due to this reaction could be fatal.

Don't take Rozerem if you're taking LUVOX^® (fluvoxamine) or have severe liver problems.

Talk with your healthcare provider if you have a history of depression, mental illness, or suicidal thoughts. Call your healthcare provider if your insomnia worsens or is not better within 7-10 days.

Worsening of depression, including suicidal thoughts and completed suicides, hallucinations, and nightmares can occur with Rozerem.

If you experience sleepwalking, driving, eating, or other behaviors while not fully awake, without remembering the event, contact your doctor immediately. There is a higher chance of these behaviors if you drink alcohol with Rozerem.

Don't drive or operate machinery until you know how you'll react to Rozerem.

Take Rozerem right before bed.

Do not drink alcohol or take other medicines that can make you sleepy when using Rozerem.

Rozerem may affect testosterone and prolactin. Consult your doctor if you experience changes in your period, libido, or problems with fertility.

Side effects may include somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.

For more information, please see the complete Prescribing Information, including the Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

LUVOX^® is a registered trademark of Solvay Pharmaceuticals, Inc.

*As with other sleep products, until you know how you'll react to Rozerem, you should avoid engaging in hazardous activities that require concentration, such as driving or operating heavy machinery.

**According to a recent study in older adults, Rozerem has not been shown to affect middle-of-the-night balance, mobility, or memory. However, the results of this study cannot be generalized across the entire older adult population.

Rozerem^® is a registered trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals America, Inc.

© 2009 Takeda Pharmaceuticals North America, Inc.
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