Rozerem (ramelteon) by Takeda Pharmaceuticals North America in July received FDA approval for the treatment of insomnia characterized by difficulty with sleep onset, according to a company news release. Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years. It will be available to patients by late September.
Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence. It has not been designated as a controlled substance. All other prescription medications indicated for insomnia are classified as schedule IV controlled substances, according to the release.
Rozerem should be taken within 30 minutes before going to bed, and activities should be confined to those necessary to prepare for bed, according to the release. Patients should not take Rozerem with or immediately after a high-fat meal. Patients should not engage in hazardous activities that require concentration after taking Rozerem.
The most common adverse events associated with Rozerem were somnolence, dizziness and fatigue.
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