How Rozerem May Help You Get to Sleep Commonly Used Sleep Aids How to Take Rozerem What to Expect With Rozerem What if I Am Taking Other Medications? Frequently Asked Questions Prescribing Information

How to Take Rozerem

Take the recommended dose of Rozerem within 30 minutes of going to bed. You should avoid eating a meal with a high fat content immediately before taking Rozerem as this can interfere with the absorption of the drug. You should avoid taking Rozerem with alcohol.

You should avoid taking Rozerem if:

You have severe liver impairment. Rozerem should be used with caution in those with moderate liver impairment.
You are taking LUVOX^® (fluvoxamine). Rozerem should be used with caution in patients taking other less strong CYP1A2-inhibiting drugs.

Learn About How to Take Rozerem

In conjunction with your use of Rozerem, you may also want to try modifying your lifestyle habits associated with sleep. The Rozerem Sleep Support Program is designed to help you develop those good sleep habits through emails, articles, and newsletters. When you join this free program, you will receive:

A personalized, 14-day program to help get you back to sleep
Helpful tips and advice on how to improve your sleep habits
A way to track your progress

Sign up for the Rozerem Sleep Support Program here.

NEXT: What to Expect With Rozerem

Find out how well you're sleeping. Get Your Sleep Quality Score

During your next appointment, talk to your healthcare provider about your sleep. Create Your Sleep Discussion Guide

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What assures me about my sleep aid is that it is non–habit-forming, it won't leave me feeling groggy the next day,** I can take it as long as I need it, 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.

*You must meet eligibility requirements.

**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.