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This page is an AI-assisted Turkish summary of the study presented at the 26th World Congress of Psychiatry. The study belongs to the presenting authors; please refer to the original source when citing it.

EV1267

Effect of daridorexant on wakefulness throughout the night: a post hoc analysis of a randomized, double-blind, active-reference (zolpidem) study in patients with insomnia disorder

EFFECT OF DARIDOREXANT ON WAKEFULNESS THROUGHOUT THE NIGHT: POST-HOC ANALYSIS OF A RANDOMISED, DOUBLE-BLIND, ACTIVE REFERENCE (ZOLPIDEM) STUDY IN PATIENTS WITH INSOMNIA DISORDER

Daridorexant reduced wake time after sleep onset throughout the night in a dose-dependent manner in insomnia disorder, with the 50 mg dose producing a numerically greater reduction than zolpidem 10 mg in the second half of the night.

The objective was to compare the dose–response effects of daridorexant (5, 10, 25, and 50 mg) on wake time after sleep onset (WASO), measured by polysomnography (PSG), by quarter of the night (QoN), against placebo and the GABA receptor agonist zolpidem. This study is a post hoc analysis of a double-blind, randomized, placebo-controlled, parallel-group, phase 2 dose–response study (NCT02839200) conducted in adults aged 18–64 years with insomnia disorder. Group sizes were 60 for daridorexant 5 mg, 58 for 10 mg, 60 for 25 mg, 61 for 50 mg, 60 for placebo, and 60 for zolpidem 10 mg; mean baseline WASO ranged from 94.0 to 99.6 minutes across groups. WASO was evaluated using descriptive statistics in two-hour intervals (Q1–Q4) over an eight-hour period on Days 1 and 2 (primary endpoint), Days 15 and 16, and Days 28 and 29, with baseline values derived from two PSG nights during the run-in period. In Q1 and Q2, daridorexant produced a response similar to that of zolpidem 10 mg. In Q3, mean reductions in WASO were numerically greater with daridorexant 25 mg and 50 mg than with zolpidem 10 mg (−16.15 minutes and −13.49 minutes, respectively, versus −9.73 minutes). In Q4, the mean reduction in WASO was −17.51 minutes with daridorexant 50 mg and −7.81 minutes with zolpidem 10 mg; the most pronounced effect of the 50 mg dose on WASO occurred in this quarter, and similar effects were also observed on Days 15 and 16 and Days 28 and 29. In conclusion, daridorexant produces a dose-dependent reduction in wakefulness throughout the night, beginning on the first night of treatment and sustained over 30 days.

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