Rozerem, a prescription medicine, is licensed to treat insomnia for people who have difficulty falling asleep. The sleep medication, which works by stimulating melatonin receptors in the body, is not a controlled substance and is not habit-forming. Rozerem comes in the form of a tablet and is only available in an 8 mg strength. Potential side effects may include drowsiness, fatigue, and dizziness.
What Is Rozerem?
Rozerem® (ramelteon) is a prescription sleep medication that has been licensed as an insomnia treatment for people with difficulty falling asleep. While many other sleep medications are only approved for short-term use (usually 7 to 10 days), Rozerem has been shown to be effective for treating insomnia for at least six months.
The drug is manufactured by Takeda Pharmaceuticals.
How Does It Work?
Rozerem works by stimulating melatonin receptors in the body. This helps people to fall asleep. Unlike many other insomnia medications, it is not habit-forming and is not a controlled substance.
The medication has been evaluated in several clinical studies for insomnia. In studies of Rozerem for chronic insomnia, people who took it fell asleep faster than people who did not take it. Similar results were seen in a study in people with transient insomnia (insomnia that comes and goes).
Studies have shown that it does not cause a "hangover" effect in the morning and does not cause rebound insomnia (worsening of insomnia after stopping a medication).
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed January 11, 2007.
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