FDA approves Takeda’s non-addictive sleeping pill

The new drug is the first prescription insomnia treatment that has not been classified as a controlled substance by the US Drug Enforcement Administration.

Rozerem has avoided the controlled substance designation because studies have shown it is the first and only prescription sleep medication that has shown no evidence of abuse and dependence; and this could give Rozerem an edge over its insomnia treatment rivals when it goes to market.

Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years. The drug has a unique therapeutic mechanism of action that selectively targets two receptors located in the brain’s suprachiasmatic nucleus (SCN). The SCN is known as the body’s “master clock” because it regulates 24-hour, or circadian, rhythms including the sleep-wake cycle.

“People with insomnia are not only affected by their sleeplessness at night; insomnia’s impact is also in how they feel and function the next day,” said Dr Thomas Roth, director of the Sleep Disorders and Research Center, Detroit, Mich.

“Current therapies often used for insomnia work by broadly inhibiting the activity of neurons in the brain,” added Dr Roth. “Ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process, and has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day ‘hangover’ effects.”

Takeda Pharmaceuticals says Rozerem will be available for patients by late September.