
[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of ... Full Alert
See the MedWatch notification at the beginning of the monograph.
Ramelteon is used to help patients who have sleep-onset insomnia (difficulty falling asleep) fall asleep more quickly. Ramelteon is in a class of medications called melatonin receptor agonists. It works similarly to melatonin, a natural substance in the brain that is needed for sleep.
See the MedWatch notification at the beginning of the monograph.
Ramelteon comes as a tablet to take by mouth. It is usually taken once a day, no earlier than 30 minutes before bedtime. Do not take ramelteon with or shortly after a high fat meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ramelteon exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You may become sleepy soon after you take ramelteon. After you take ramelteon, you should complete any necessary bedtime preparations and go to bed. Do not plan any other activities for this time.
Your insomnia should improve after you begin treatment with ramelteon. Call your doctor if your insomnia does not improve at the beginning of your treatment. Also call your doctor if your insomnia gets worse or you notice unusual changes in your behavior at any time during your treatment.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
- Rozerem®
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