Quviviq improves sleep and daytime functioning in sufferers with insomnia

January 21, 2022

3 minutes read

Source/Disclosures

Disclosure:
Mignot reports receiving research or clinical trial funding from Apple, Avadel, Axsome, Huami, Jazz Pharmaceuticals, Sunovion, and Takeda, as well as consulting fees or speaker conference reimbursements from Avadel, Centessa Pharmaceuticals, Dreem, Idorsia, Jazz Pharmaceuticals, and Takeda. The relevant financial information of all other authors can be found in the study.

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Quviviq 25 mg and 50 mg improved sleep in patients with insomnia, according to results from two phase 3 randomized, double-blind, placebo-controlled studies published in The Lancet Neurology.

Quviviq (daridorexant, Idorsia), which recently received FDA approval to treat adults with insomnia, also improved daytime when taken at its 50 mg dose. The treatment showed a favorable safety profile.

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“The novel dual orexin receptor antagonist daridorexant was developed as an anti-insomnia drug that promotes the sleep onset process and sleep maintenance, but without morning after-effects that could impair daytime .” Emmanuel mignotMD, PhD, the Craig Reynolds Professor of Sleep Medicine at Stanford University and Director of the Stanford Center for Narcolepsy and colleagues. “In phase 2 dose-ranging studies, daridorexant improved sleep variables in adults and older adults (aged 65-85 years) with insomnia without inducing residual sleepiness the next morning.

“Hence, we hypothesized that daridorexant might also improve daytime ,” they added. “Here we present the results of two placebo-controlled phase 3 studies (Study 1 and Study 2) in which we aimed to evaluate the safety and efficacy of daridorexant in people with insomnia.”

Researchers conducted the multicenter studies at 156 sites in 17 countries in adults with insomnia. Between June 4, 2018 and February 25, 2020, in the first study, they randomly assigned 930 participants in a 1:1:1 ratio to daridorexant 50 mg, 25 mg, or placebo. Between May 29, 2018 and May 14, 2020, in the second study, they randomly assigned 924 participants in a 1:1:1 ratio to receive daridorexant 25 mg, 10 mg, or placebo. In both studies, participants received the intervention every evening for 3 months, with participants, investigators, and on-site staff masked to treatment assignment. The primary endpoints at months 1 and 3 were change from baseline in wake time after sleep onset (WASO) and latency to sustained sleep (LPS) as assessed by polysomnography. Secondary endpoints were change from baseline in self-reported total sleep time and the sleepiness domain score of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) at months 1 and 3.

In the first study, results showed a significant reduction in WASO and LPS in participants who received daridorexant 50 mg vs. placebo at Month 1, and those who received daridorexant 25 mg vs. placebo at Months 1 and 3 a significant improvement in self-reported total sleep time at months 1 and 3 and IDSIQ scores for sleepiness area at months 1 and 3 compared to those receiving placebo. In addition, those who received daridorexant 25 mg showed a significant improvement in self-reported total sleep time at months 1 and 3, but not IDSIQ scores for sleepiness area, compared to those who received placebo.

In the second study, the daridorexant 25 mg group showed a significant reduction in WASO compared to the placebo group at months 1 and 3; However, Mignot and colleagues observed no significant differences in LPS at months 1 or 3. The daridorexant 25 mg group had a significant improvement in self-reported total sleep time at months 1 and 3 compared to the placebo group, but not the IDSIQ scores for the drowsiness zone. The researchers observed no significant differences between participants in the daridorexant 10 mg group in terms of WASO, LPS, self-reported total sleep time, or IDSIQ scores in the sleepiness range compared to the placebo group.

The treatment groups had a comparable overall incidence of adverse events. In all groups, the most side effects were nasopharyngitis and headache. In the first study, there was a total of one death in the daridorexant 25 mg group; however, this was not considered treatment related.

“These two studies demonstrate the efficacy of daridorexant on objective sleep induction and maintenance, patient-reported sleep quantity and quality, and (at a 50 mg dose) daytime functioning as measured by the IDSIQ sleepiness domain,” Mignot said colleagues wrote. “The highest dose (daridorexant 50 mg) was most effective on night and day variables, followed by 25 mg, which showed efficacy only on sleep variables; the 10 mg dose was not effective. Daridorexant was well tolerated at all doses and was safe.”

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