50-mg dose shows significant improvement versus placebo for sleep onset, sleep maintenance, and total sleep time<\/p>\n<\/h3>\n
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FRIDAY, Feb. 4, 2022 (HealthDay News) — Daridorexant (50 mg) improves both nighttime symptoms and daytime functioning in people with insomnia disorder, according to a study published in the Feb. 1 issue of The Lancet Neurology<\/em>.<\/p>\n Emmanuel Mignot, M.D., from the Stanford Center for Sleep Research and Medicine in Palo Alto, California, and colleagues conducted two phase 3 randomized controlled trials at 156 sites in 17 countries. The authors randomly assigned 930 adults with insomnia disorder (1:1:1) to receive either daridorexant (50 mg, 25 mg) or placebo in study 1 and 924 adults to receive either daridorexant (25 mg, 10 mg) or placebo in study 2 every evening for three months.<\/p>\n The researchers found that in study 1, wake time after sleep onset (WASO) and latency to persistent sleep (LPS) were significantly reduced among participants in the daridorexant 50-mg group versus participants in the placebo group at month 1 and month 3. Similar results for WASO and LPS were seen among those receiving daridorexant 25 mg versus the placebo group. The daridorexant 50-mg group also had significantly improved self-reported total sleep time and Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) scores at month 1 and month 3 compared with placebo. However, the daridorexant 25-mg group only saw significant improvements in self-reported total sleep, not IDSIQ sleepiness domain scores. In study 2, WASO was significantly reduced in the daridorexant 25-mg group versus placebo at month 1 and month 3, but there were no significant differences seen in LPS. The daridorexant 25-mg group saw significant improvement in self-reported total sleep time at month 1 and month 3, but not in IDSIQ sleepiness domain scores at either timepoint. No significant improvements for any measures were seen for the daridorexant 10-mg group versus placebo. The overall incidence of adverse events was similar between treatment groups across studies.<\/p>\n “It is exciting to see that insomnia is finally not solely viewed as a nighttime problem but as a cause of daytime suffering,” Mignot said in a statement.<\/p>\n Several authors disclosed financial ties to pharmaceutical companies, including Idorsia Pharmaceuticals, which manufactures daridorexant and funded the study.<\/p>\n Abstract\/Full Text (subscription or payment may be required)<\/a><\/p>\n <\/i><\/p>\n