FDA Approves New Drug for Insomnia in Adults

The FDA has approved daridorexant (Quviviq) 25 mg and 50 mg for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Daridorexant is a dual orexin receptor antagonist that blocks the binding of the wake-promoting orexin neuropeptides, and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.

The FDA recommended that daridorexant be classified as a controlled substance.

The FDA’s approval of daridorexant was based on clinical trials including 1,854 adults with insomnia at over 160 clinical trial sites across 18 countries. The trials demonstrated that daridorexant was associated with significant improvement versus placebo on objective measures of sleep onset and sleep maintenance and patient-reported total sleep time. The 50-mg dose of daridorexant demonstrated a significant reduction in patient-reported daytime sleepiness.

The most common adverse reactions in clinical trials were headache, somnolence, or fatigue.

Daridorexant is a product of Idorsia Pharmaceuticals and is expected to be available in May 2022.