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

So Just What Is "Prescribing Information"?

Prescribing Information is just what it says it is: information that is used by healthcare providers to determine if the medication is right for you. But you probably know it as that thin piece of paper that comes with your prescription and is folded more intricately than the map in your glove box.

Actually, this piece of paper tells a lot about the drug and its use, including:

How the drug works in your body
What the clinical trials found in terms of safety and efficacy
How the drug tested in certain populations, like the elderly
How to properly use the drug
If there are any precautions and warnings associated with the drug
What side effects are commonly reported
How to store the drug

If you are interested in seeing this information, click below for a downloadable copy of the Rozerem Prescribing Information including the Medication Guide.

PDF, 65K, 2p Prescribing Information

About PDF Files

Portable Document Format (PDF) files are electronic files that you can print. PDF files require Adobe Acrobat Reader, which can be downloaded at no cost from the Adobe website at www.adobe.com.

NEXT: Tools to Help You Sleep

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

Prescribing Information | Contact Us | Privacy Policy | Terms & Conditions of Use | Healthcare Professionals

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.

*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.