FDA Approves Daridorexant for Adults With Insomnia

The treatment yielded significant improvements for sleep onset and sleep maintenance.

The US Food and Drug Administration (FDA) has approved daridorexant (QUVIVIQ) 25 mg and 50 mg for the treatment of adults with insomnia for sleep onset or sleep maintenance.

The approval, awarded to Idorsia Pharmaceuticals, was based on an 1854 patient study at 160 sites across 18 countries.

The Drug

The dual orexin receptor antagonist treatment blocks the binding of the wake-promoting neuropeptides orexins and potentially turns down overactive wakefulness.

"After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and of the potential of orexin receptor antagonism, we designed daridorexant to help address several issues people with insomnia face,” Martine Clozel, MD and Chief Scientific Officer of Idorsia, said in a statement. “Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects."

The Trial

In the phase 3 trial, the treatment resulted in significant improvement on objective measures of sleep onset and sleep maintenance, as well as total sleep time in comparison to placebo.

In addition, the 50 mg dosage showed a significant reduction in patient reported daytime sleepiness using a validated instrument.

Safety and the Future

For safety, common adverse reactions found in the trials included headache (placebo: 5%, 25 mg: 6%, 50 mg: 7%,) and fatigue (placebo: 4%, 25 mg: 6%, 50 mg: 5%).

The FDA is also classifying daridorexant as a controlled substance. The medication is expected to be available in May.