Insomnia Drugs

FDA grants approval to insomnia drug

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The FDA granted approval to Quviviq to treat adults with insomnia.

Quviviq (daridorexant, Idorsia) is a dual orexin receptor antagonist that blocks the binding of wake-promoting neuropeptides orexins and is thought to minimize overactive wakefulness, as opposed to sedative treatments.

FDA approval stamp
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“After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and of the potential of orexin receptor antagonism, we designed daridorexant to help address several issues people with insomnia face,” Martine Clozel, MD, chief scientific officer of Idorsia, said in a company release. “Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects.”

Daridorexant was cleared for doses of 25 mg and 50 mg on the heels of two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies during a phase 3 clinical program, which included 1,854 patients encompassing 160 clinical trial sites in 18 countries.

Participants received daridorexant or placebo once a day, in the evening, for 3 months. Researchers on the first study randomly assigned 930 participants to a 50-mg dose, while 924 participants received the 25-mg dose in the second study. Both studies included a 7-day placebo run-out period, after which patients could enter a 9-month, double-blind, placebo-controlled extension study. A total of 600 participants were treated for at least 6 months of cumulative therapy, including 373 treated for at least 12 months.

The drug produced effective boosts to patients’ sleep onset, maintenance and time. The 50-mg dose produced measurable easing of patients’ daytime somnolence.

The FDA recommended daridorexant be classified as a controlled substance. It is scheduled to be released to the public in May 2022.

Insomnia Drugs Linked to Increased Mortality.

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But confounding could partly explain the findings in this observational study.

Hypnotic drugs, which many adults take for insomnia, have been associated with increased risks for cancer and death. Investigators clarified the extent of those risks by analyzing the medical records of 10,531 case patients (mean age, 54) who received prescriptions for hypnotic drugs and records of 23,674 matched controls who did not receive such prescriptions. Mortality data were acquired using the Social Security Death Index.

After a mean follow-up of 2.5 years, 6.1% of patients who received hypnotic drug prescriptions and 1.2% of patients who did not receive such prescriptions had died. Adjusted for multiple variables (e.g., age, tobacco use, body-mass index) and stratified by multiple comorbidities, the hazard ratios (HRs) for all-cause death were 3.6 for patients prescribed 1 to 18 doses yearly, 4.4 for patients prescribed 18 to 132 doses yearly, and 5.3 for patients prescribed >132 doses yearly compared with nonusers — a dose–response relation. The results were similar when the analysis was restricted to zolpidem (Ambien) or temazepam (Restoril), the most commonly prescribed hypnotic drugs. Patients who were prescribed >132 doses yearly of any hypnotic drug were also at significantly increased risk for cancer (HR, 1.4 compared with nonusers).

Comment: In this study, receiving a prescription for a hypnotic drug — even for 18 doses yearly — was associated with increased all-cause mortality risk, and receiving a prescription for many doses (>132 doses yearly) was associated with increased cancer risk. Given its design, this study does not prove that hypnotic drugs cause death or cancer. In addition, the authors were unable to control for psychiatric diagnoses such as depression or anxiety; therefore, residual confounding is possible. Nevertheless, the authors appropriately question the safety of these commonly prescribed drugs.

Source:Journal Watch General Medicine