The FDA has approved a New Drug Application for ramelton 8-mg tablets (Rozerem™, Takeda), indicated for the treatment of insomnia characterized by difficulty with sleep onset.
This is the first prescription sleep medication that has shown no evidence of abuse and dependence. As a result, it has not been designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). All other prescription drugs for insomnia are classified as Schedule IV controlled substances by the DEA. Ramelton is also the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years. It will be available by late September.
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Ramelton can be prescribed for long-term use, but patients should see their health care providers if insomnia does not remit or if it worsens.
Ramelton has been associated with decreased testosterone levels and elevated prolactin levels. It has not been studied in children or adolescents.