September 16, 2025Open Access

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

Key Points

Daridorexant significantly reduces awakenings during the night in patients with insomnia disorder.
At the highest dose of 50mg, daridorexant outperformed zolpidem, especially in the latter half of the night.
The analysis utilized polysomnography to measure wake time after sleep onset across different treatment nights.
These findings support daridorexant's potential as a viable treatment for managing insomnia symptoms.

Abstract

Introduction Daridorexant, a dual orexin receptor antagonist DORA which works by selectively reducing the orexin-induced wake signalling, has been shown to induce a dose-dependent reduction in wake time after sleep onset WASO in patients with insomnia disorder (Dauvilliers et al. Ann Neurol 2020; 87 347–356). Objectives This exploratory analysis examined the efficacy of daridorexant in reducing the duration of awakenings in each quarter of the night, when compared to placebo and to the GABA-receptor agonist zolpidem, which induces sleep through widespread CNS sedation. Methods This was a multi-centre, double-blind trial (NCT02839200), including adult (18–64y) patients with insomnia randomized (1:1:1:1:1:1) to placebo, daridorexant (5, 10, 25, or 50mg), or zolpidem (10mg) for 30 days. Polysomnography PSG-determined WASO was evaluated using descriptive statistics by quarter of the night (Q1–Q4) i.e. every 2 hours over 8 hours at Days 1 Days 15 Q4: –17.51 min versus –7.81 min). Similar effects were seen at Days 15 & 16, and Days 28 & 29. Image 1: Conclusions In patients with insomnia disorder, daridorexant reduces the duration of awakenings throughout the entire night, including the last two quarters. Disclosure of Interest B. Steiniger-Brach Employee of: Idorsia Pharmaceuticals, O. Briasoulis Employee of: Idorsia Pharmaceuticals, A. Olivieri Employee of: Idorsia Pharmaceuticals, S. Pain Employee of: Idorsia Pharmaceuticals, L. Palagini Consultant of: Bruno, Fidia, Idorsia Pharmaceuticals, Pfizer, Sanofi, Pharmanutra, Neopharmed Gentili, D. Kunz Consultant of: Austrian Association of Skiing (ÖSV), Idorsia Pharmaceuticals, Speakers bureau of: AbbVie, Idorsia Pharmaceuticals, German Ministry for Economy (BMWi), Austrian Association of Skiing (ÖSV), P.-A. Geoffroy Consultant of: Apneal, Arrow, Biocodex, Dayvia, Di&Care, Idorsia Pharmaceuticals, Janssen-Cilag, Jazz pharmaceuticals, Myndblue, Mysommeil, Posos, ResilEyes, Withings, Speakers bureau of: Biocodex, Bioprojet, Ibsa, Idorsia Pharmaceuticals, Janssen-Cilag, Isis Medical, Jazz pharmaceuticals, Lundbeck, MySommeil, Withings.

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