On Jan. 10, 2022, Idorsia announced that the FDA approved QUVIVIQ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
About QUVIVIQ
QUVIVIQ is a prescription medication indicated for the treatment of adult patients with insomnia. It is a tablet taken orally once per night within 30 minutes before going to bed with at least seven hours remaining before planned awakening.
QUVIVIQ is a dual orexin receptor antagonist (DORA), which blocks the binding of the wake-promoting neuropeptides orexins. DORAs are thought to turn down overactive wakefulness, as opposed to sedating the brain.
According to Idorsia’s press release, the FDA approval of QUVIVIQ is based on an extensive clinical program that demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, as well as patient reported total sleep time.
The FDA has recommended that QUVIVIQ be classified as a controlled substance. It is expected to be available to patients in May 2022 following scheduling by the U.S. Drug Enforcement Administration.
About chronic insomnia
Chronic insomnia is a sleep disorder characterized by persistent difficulties in falling or staying asleep, resulting in disrupted sleep patterns and daytime symptoms. It significantly impacts various aspects of life, affecting work performance, decision-making, relationships, mood and overall quality of life. Approximately 10% of individuals experience chronic insomnia, defined by sleep disturbances occurring at least three times a week and lasting for a minimum of three months.
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