FDA Approves Novel Drug to Treat Insomnia

The U.S. Food and Drug Administration (FDA)has approved Quviviq (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia.The FDA has recommended that Quviviq be classified as a controlled substance, and it is expected to be available to patients in May 2022, following scheduling by the U.S Drug Enforcement Administration, according to amedia release by Idorsia Ltd, maker of Quviviq.Unlike many insomnia medications that act to sedate the brain, Quviviq is a dual orexin receptor antagonist, which works to reduce overactive wakefulness.The efficacy of Quviviq was evaluated in two multicenter, randomized, double-blind, placebo-controlled studies. A total of 1,854 adults with insomnia (as defined byDSM-5) were randomized to receive Quviviq or placebo once daily in the evening for three months. Thefirst study included 930 adults randomized to Quviviq (50 mg or 25 mg) or placebo. Thesecond study included 924 adults randomized to Quviviq (25 mg or 10 mg) or placebo.In both trials, the researchers compared changes in Latency to Persistent Sleep (a measure of how long it takes to fall asleep) and Wake After Sleep Onset (a measure of sleep maintenance), as indicated by polysomnography in a sleep laboratory. The study participants also reported their total sleep times, based on their recordings in a sleep diary throughout the trial. Study participants who took Quviviq (25 and 50 mg) showed a statistically significant improvement over placebo on sleep maintenance a...
Source: Psychiatr News - Category: Psychiatry Tags: DEA falling asleep FDA Idorsia Ltd insomnia Philip Muskin Quviviq wake after sleep Source Type: research