Ramelteon
Rozerem (ramelteon) is a prescription sleep medication that works by targeting the body's natural sleep-wake cycle. It is specifically used to treat insomnia characterized by difficulty falling asleep. Unlike many other sleep aids, Rozerem is not classified as a controlled substance.
Rozerem is a melatonin receptor agonist prescription medication used to help people fall asleep faster for the treatment of insomnia.
Key facts at a glance
- RxNorm
- 603159
- Generic
- Rozerem
- Class
- brand-name
- Brands
- —
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- —
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Rozerem is FDA-approved for the treatment of insomnia characterized by difficulty with sleep onset (trouble falling asleep). It is indicated for adult use and is particularly considered for patients who may have concerns about dependence with other sleep medications.
Rozerem is a melatonin receptor agonist that works by selectively binding to melatonin MT1 and MT2 receptors in the brain's suprachiasmatic nucleus (the body's master clock). This action helps regulate the sleep-wake cycle and promotes the natural onset of sleep.
Rozerem should be taken within 30 minutes of bedtime. It is not recommended for use with fluvoxamine or in patients with severe liver impairment. Common side effects may include drowsiness, dizziness, and fatigue. Patients should avoid driving or operating machinery until they know how the medication affects them. As a non-benzodiazepine hypnotic, it has a lower risk of dependence compared to some other sleep medications.
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 9, 2026. · Read our editorial policy