Quviviq (daridorexant) is now available for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Quviviq contains daridorexant, an orexin receptor antagonist. Approval was based on data from a comprehensive development program that included two phase 3 studies (ClinicalTrials.gov Identifier: NCT03545191 [Study 1] and NCT03575104 [Study 2]). The double-blind studies compared the efficacy and safety of daridorexant to placebo in 1854 patients 18 years of age and older with insomnia for 3 months. 

Findings from Study 1 and Study 2 showed that daridorexant demonstrated statistically significant and clinically meaningful improvements in sleep onset, sleep maintenance, and patient reported total sleep time. Patients treated with daridorexant also had a significant reduction in daytime sleepiness, as assessed by a validated sleep diary questionnaire.

The most common adverse reactions reported were headache and somnolence or fatigue.  Daridorexant was not associated with next morning residual effects, rebound insomnia, or withdrawal symptoms upon discontinuation.

As with other hypnotics, there is a risk of CNS depressant effects, worsening of depression or suicidal ideation, sleep paralysis, hypnagogic/hypnopompic hallucinations, cataplexy-like symptoms, and complex sleep behaviors. Quviviq is contraindicated in patients with narcolepsy. Additionally, the treatment has not been studied in patients with moderate obstructive sleep apnea (OSA) requiring CPAP, severe OSA, or severe COPD; the effects of Quviviq on respiratory function should be considered if prescribed to patients with compromised respiratory function.

Quviviq tablets are available in 2 dosage strengths: 25mg and 50mg. Coadministration with strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers should be avoided. Patients taking moderate CYP3A4 inhibitors or those with moderate hepatic impairment should not take more than 25mg once per night. Quviviq is not recommended for patients with severe hepatic impairment.

Treatment should be administered within 30 minutes of going to bed, with at least 7 hours remaining prior to planned awakening, as the risk of daytime impairment is increased if the drug is taken with less than a full night of sleep remaining. Time to sleep onset may be delayed if Quviviq is take with or soon after a meal.

References

  1. Idorsia’s new treatment Quviviq (daridorexant) is now available in the US for adults living with insomnia. News release. Idorsia Pharmaceuticals Ltd. Accessed May 2, 2022. https://www.globenewswire.com/news-release/2022/05/02/2433104/0/en/Idorsia-s-new-treatment-QUVIVIQ-daridorexant-is-now-available-in-the-US-for-adults-living-with-insomnia.html
  2. Quviviq. Package insert. Idorsia Pharmaceuticals Ltd; 2021. Accessed January 10, 2022. https://www.idorsia.us/documents/us/label/Quviviq_PI.pdf