FDA Approves Daridorexant for Insomnia

The Food and Drug Administration (FDA) approved daridorexant (Quviviq; Idorsia, Radnor, PA) for insomnia treatment. In the phase 3 clinical program, daridorexant demonstrated significant improvement in insomnia compared with placebo based on objective measures of sleep onset, sleep maintenance, reported total sleep time.

Clinical studies observed change from baseline to month 1 and month 3 in Latency to Persistent Sleep (LPS) and Wake After Sleep Onset (WASO) measured objectively by polysomnography. 
 There was also statistically significant improvement in participant-reported Total Sleep Time (sTST).

In Study 1 (NCT03545191), doses of 25 mg and 50 mg daridorexant showed a statistically significant improvement vs placebo on polysomnography (LPS, WASO) and sTST, at month 1 and month 3. In Study 2 (NCT03575104), daridorexant 25 mg showed a improvement on WASO and sTST. Daridorexant 10 mg did not show improvement in any measurement throughout the period. The efficacy of daridorexant was similar across subgroups (n=1,236) based on age, sex, race, and region.

 Guy Braunstein, MD and Head of Global Clinical Development of Idorsia, commented:
“In our investigation of daridorexant we were able to demonstrate an improvement on objective sleep parameters, as well as improvement in patient-reported outcomes. What is truly impressive, we have shown a dose response in the efficacy of daridorexant, with no increase in the rate of somnolence or fatigue with increasing doses.”

Daridorexant is a dual orexin receptor antagonist as opposed to treatments that commonly sedate the brain. The FDA recommended scheduling of daridorexant as a controlled substance by the Drug Enforcement Agency (DEA).

The most common adverse events were headache (placebo, 5%, 25 mg; 6%, 50 mg; 7%,) and fatigue or somnolence (placebo, 50 mg; 5%; 4%, 25 mg; 6%).