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

What to Expect With Rozerem

Do you think ...

That overcoming your sleep issue is something you will never check off your list?
That falling asleep quickly is a myth?
You will have to put up with possible dependence on a sleep aid and feeling groggy the next morning?

See, there are different kinds of prescription medications that are indicated for use in people with insomnia: sedative hypnotic drugs and non-sedative hypnotic drugs. Sedative hypnotic drugs can help your symptoms of insomnia, but they may also affect parts of the brain that may be associated with balance and memory. And controlled substances can lead to abuse and dependence.

Rozerem Is Different

Rozerem is the only prescription melatonin receptor agonist medication. Rozerem is thought to promote sleep by working with your normal sleep-wake cycle, which is regulated by the body's internal clock.

Rozerem may have side effects, including somnolence, dizziness, fatigue, nausea, and exacerbated insomnia. Rozerem may also affect testosterone and prolactin. Talk to your healthcare provider about how this may affect you.

Studies show that Rozerem is non–habit-forming.
Rozerem helps you fall asleep fast and wake up without feeling groggy.**
Rozerem can be used for as long as your healthcare provider recommends it.

Knowing what to expect with your sleep medication can make all the difference. If you still have more questions about Rozerem, read our FAQs and ask your doctor if Rozerem is right for you.

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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,** 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.