FDA Approves Daridorexant for Treatment of Insomnia

Daridorexant (Quviviq, Idorsia Pharmaceuticals) is indicated for adults who have difficulty falling asleep and / or maintaining sleep.

The FDA has approved daridorexant (Quviviq, Idorsia Pharmaceuticals) for the treatment of people with insomnia characterized by difficulty falling asleep and / or maintaining sleep.

The FDA approval of daridorexant in doses of 25 mg and 50 mg is based on an extensive clinical program that included 1,854 people with insomnia in more than 160 clinical trial sites in 18 countries.

“As mentioned in the definition of insomnia, the disorder is not only a nocturnal problem but also affects the patient’s ability to function during the day. Although the personal and societal burden of insomnia is well known, amplifying the effects of insomnia, both night and day, remains critical to meeting patient needs, ”said Thomas Roth, PhD, Director of Sleep Disorder and Research Center at Henry Ford Hospital, in a press release.

Daridorexant is a dual orexin receptor antagonist that blocks the binding of neuropeptides orexins, which are associated with sleep-wake regulation. According to Idorsia Pharmaceuticals, the drug is said to reduce an overactive wakefulness instead of sedating the brain.

During the Phase 3 clinical program, daridorexant showed a significant improvement in objective measurements of falling asleep and sleep maintenance, as well as individually reported total sleep time, compared to placebo, according to Idorsia Pharmaceuticals.

The 50 mg dose of daridorexant investigated in either study demonstrated a significant reduction in patient-reported daytime sleepiness using a valid instrument and is consistent with United States prescribing information.

“The properties of daridorexant include a strong inhibition of both orexin receptors, rapid absorption for the onset of sleep and a pharmacokinetic profile such that about 80% of the daridorexant is eliminated after a night of sleep to minimize residual effects,” said Martine Clozel, MD, Idorsia’s Chief Scientific Officer, in the press release.

In the clinical trials, people with insomnia were randomized to receive daridorexant or placebo once a day in the evening for 3 months. One study randomized 930 people randomized to 50 mg, 25 mg daridorexant, or placebo, while study 2,924 people randomized 25 mg, 10 mg daridorexant, or placebo.

At the end of the 3-month treatment period, both studies included a 7-day placebo run-out phase, after which participants could participate in a 9-month, double-blind, placebo-controlled extension study. Approximately 600 people received cumulative treatment for at least 6 months, including 373 who received treatment for at least 12 months.

The primary efficacy endpoints for both studies were change from baseline at month 1 and month 3 in latency to sustained sleep – a measure of sleep induction – and wake after sleep onset (WASO) – a measure of sleep maintenance – as measured objectively by polysomnography in a sleep laboratory.

The secondary endpoints of the Type I error control statistical test hierarchy were patient reported total sleep time (sTST), which was evaluated at home each morning using a validated sleep diary questionnaire.

In Study 1, doses of 25 mg and 50 mg showed a statistically significant improvement in all 3 measurements over placebo, in both Months 1 and 3. In Study 2, the 25 mg dose showed a statistically significant improvement in WASO and sTST in Months 1 and 3 versus placebo. The 10 mg dose showed no significant improvement in the 3 measurements.

The 50 mg dose also showed a significant reduction in daytime sleepiness compared to placebo, as measured by the sleepiness domain score from the Insomnia Daytime Symptoms and Impacts Questionnaire in months 1 and 3. The results on this endpoint for the 25 mg Dose did not reach statistical significance in either study at either time point.

The most common side effects were headache and drowsiness or fatigue.

The 10 mg dose is not an FDA approved dose.

The FDA recommended that daridorexant be classified as a controlled substance, and the drug is expected to be available in May 2022, according to planning by the US Drug Enforcement Administration.


Idorsia receives US FDA approval for Quviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. Idorsie. Press release. January 10, 2022. Accessed January 10, 2022. https://www.idorsia.us/documents/us/media-releases/2201_us-fda-approval-quviviq-announcement.pdf

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