Concomitant use with strong CYP3A4 inhibitors should be avoided. The use of daridorexant is contraindicated in patients with severe hepatic impairment a maximum daily dose of 25 mg is recommended in those with moderate impairment. Patients should be cautioned about next-day driving impairment when initiating treatment. However, the mean effect after 4 days of treatment was not significant. The difference in performance after the first dose, measured by change in standard deviation of lateral position, was significant compared with placebo for both dose groups. Rare occurrences of sleep paralysis were reported in the 25-mg and 50-mg groups, and hypnagogic/hypnopompic hallucinations were reported in the 25-mg group.Ī randomized, double-blind, placebo- and active-controlled 4-way crossover study assessed the next-day effects of the medication on driving after doses of 50 mg and 100 mg. The most common adverse events in the 25-mg, 50-mg, and placebo groups, respectively, were headache (6%, 7%, 5%), somnolence/fatigue (6%, 5%, 4%), dizziness (2%, 3%, 2%), and nausea (0%, 3%, 2%). In the extension study, 804 participants were randomly assigned to receive daridorexant 50 mg, 25 mg, or 10 mg placebo or daridorexant 25 mg/ex-placebo. The safety profile of daridorexant was established through 3 placebo-controlled studies: study 1, study 2, and a phase 3, 9-month extension study of eligible patients from the first 2 studies (NCT03679884). No statistically significant improvement was noted in the 10 mg group. Secondary end points included patient-reported subjective total sleep time (sTST), recorded using a validated sleep diary questionnaire.Īt months 1 and 3, study 1 participants who received 25 mg or 50 mg demonstrated statistically significant improvements in LPS, WASO, and sTST study 2 results showed that 25 mg led to a statistically significant improvement vs placebo in WASO and sTST. The primary efficacy end point was change from baseline in latency to persistent sleep (LPS)Īnd wake after sleep onset (WASO), measured by polysomnography at months 1 and 3. Study 2 participants received daridorexant 25 mg, 10 mg, or placebo (n = 309, 307, and 308, respectively). Study 1 included 930 participants who received daridorexant 50 mg, 25 mg, or placebo (n = 310 for all). Investigators randomly assigned 1854 patients to receive daridorexant or placebo once in the evening for 3 months. Two multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 trials (study 1, NCT03545191 study 2, NCT03575104) evaluated efficacy. 1 The approval was based on findings from a phase 3 clinical trial program in which the drug successfully demonstrated significant improvement in sleep onset, sleep maintenance, and patient- reported total sleep time. On January 7, 2022, the FDA approved daridorexant (Quviviq) for the treatment of adults with insomnia.
0 Comments
Leave a Reply. |