Saturday, 10 Jun 2023

EMA Panel Backs Daridorexant (Quviviq) for Insomnia

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended approval of daridorexant (Quviviq, Idorsia Pharmaceuticals) for the treatment of insomnia.

Daridorexant is a dual orexin receptor antagonist that has been shown to increase sleep induction, improve sleep maintenance, and improve daytime functioning.

The drug is indicated for the treatment of adults with insomnia characterized by symptoms present for at least 3 months and that affect daytime functioning considerably, the EMA panel said.  

The most common side effects are headache and somnolence.

If approved by the European Commission (EC), daridorexant will be available in 25 mg and 50 mg film-coated tablets.

US Approval

As reported by Medscape Medical News, the US Food and Drug Administration (FDA) approved daridorexant for the treatment of insomnia in adults in January.

The FDA’s decision was based partly on a phase 3 trial of adults with moderate-to-severe insomnia who were randomly assigned to receive 25 mg or 50 mg of daridorexant or a matching placebo.

The active drug was associated with dose-dependent improvements in wake after sleep onset, total sleep time, and latency to persistent sleep.

Insomnia is a common disorder characterized by difficulty falling asleep or staying asleep and by early morning awakenings. Patients with insomnia often report fatigue, irritability, and difficulty with concentration. The condition can also result in significant problems with work and social activities, thus contributing to anxiety or depression.

As with other dual orexin receptor antagonists, daridorexant competitively binds with both orexin receptors in the lateral hypothalamus to block the activity of orexin in a reversible way. This approach decreases the downstream action of the wake-promoting neurotransmitters that are overactive in patients with insomnia.

Detailed recommendations for daridorexant will be given in the summary of product characteristics, which will be published in the European public assessment report. It will also be made available in all official European Union languages if marketing authorization is granted by the EC.

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