Wednesday, January 12, 2022

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 a media 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 by DSM-5) were randomized to receive Quviviq or placebo once daily in the evening for three months. The first study included 930 adults randomized to Quviviq (50 mg or 25 mg) or placebo. The second 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 and total time sleeping after taking the medication for one and three months. Study participants who took the 10 mg dose of did not show a statistically significant improvement over those who took placebo on either measure or on total sleep time.

According to the Quviviq label, several studies evaluated the abuse potential of the medication. One study of 63 recreational sedative drug users who were given a single dose of the medication revealed high “drug liking,” suggesting potential for abuse.

Philip R. Muskin, M.D., M.A., a professor of psychiatry at Columbia University Irving Medical Center and senior consultant in consultation-liaison psychiatry at New York-Presbyterian Hospital/Columbia University Irving Medical Center, said the new medication will be an effective addition to the tools available to treat patients with insomnia. “We certainly need new drugs for insomnia,” he told Psychiatric News. “It’s a very common problem, even among people who don’t meet DSM criteria for insomnia, and insomnia is a component of so many other psychiatric disorders—depression, anxiety, trauma, among others.”

He advised psychiatrists to be cautious about prescribing to patients with a history of addiction.

“No one drug works for everyone,” Muskin said. “Many of the existing drugs that sedate the brain help people fall asleep but don’t help them stay asleep. This new medication tunes down the biological signal in our brain to stay awake. There is a need for drugs that use a different mechanism of action than sedating the brain.”

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