FDA Approves Quviviq, New DORA for Treatment of Insomnia in Adults

The dual orexin receptor antagonist (DORA) from a Swiss drugmaker will be available in May 2022.

The FDA has approved Quviviq (daridorexant) tablets to treat adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. This is the first FDA-approved drug for Swiss biopharmaceutical company Idorsia. Quviviq is scheduled to be available in pharmacies in May 2022 pending controlled substance scheduling by the Drug Enforcement Agency.

Quviviq is a dual orexin receptor antagonist (DORA) that blocks neuropeptides orexin A and orexin B from binding to receptor sites. Other drugs in this class include Belsomra (suvorexant), approved in 2014, and Dayvigo (lemborexant), which was approved in 2019.

Orexins play a vital role in various physiological functions, including promoting wakefulness. By blocking orexin action, Quviviq and other DORA drugs are thought to suppress wakefulness, setting them apart from traditional sleep agents that act by sedating the brain.

Insomnia is the most common sleep disorder, affecting more than 30% of adults in the U.S. Chronic insomnia is associated with several health conditions, including cardiovascular disease, depression, and diabetes. Quviviq offers an option for patients for whom existing insomnia treatment has failed or is not advisable.

The approval of Quviviq is based on results from two pivotal randomized phase 3 clinical studies that evaluated the safety and efficacy of Quviviq versus placebo in 1,854 adults with insomnia disorder. Participants in Study 1 were randomized to receive Quviviq 50 mg, 25 mg, or placebo. Those in Study 2 received Quviviq 25 mg, 10 mg, or placebo. After three months, patients taking Quviviq 25 mg or 50 mg showed significant improvement versus placebo in sleep onset, sleep maintenance, and patient-reported total sleep time.

Quviviq is the only DORA that has evaluated drug’s effect on daytime sleepiness in clinical trials. Participants taking the 50-mg Quviviq dose reported significantly less daytime sleepiness than those in the placebo group. Adverse reactions in the Quviviq groups were comparable to those iin the placebo group.