(305) Daridorexant and sleeping disorders: comparative study with sleeping medication (zopiclone, oxazepam).

Background: Daridorexant is indicated in the treatment of adults patients with insomnia with impact on day time for a duration of least 3 months. Daridorexant is a novel dual orexin receptor antagonist with the equipotent binding of the orexin type 1 and 2 receptor. In recent years, the orexin system has been discovered as a target for sleep medication. To treat insomnia, the pharmacological treatments recommended are benzodiazepine receptor agonist such as zopiclone and benzodiazepines such as oxazepam.

Objectives: The aim of this study was to investigate the impact on the quality of sleep of the different pharmacological treatments used in insomnia (zopiclone, oxazepam) compared to daridorexant.

Methods: We performed a disproportionality analysis with the World Health Organization global individual case safety report database (Vigibase®) from January 1967 to February 2024. To identify relevant cases, we used MedDRA preferred terms (PT) « nightmare » and « abnormal dreams ». We compared daridorexant with zopiclone and oxazepam. The information component (IC) and reporting odds ratio (ROR) were calculated. A positive 95% lower end of the IC (IC025) value >0 and lower end of the ROR 95% confidence interval (ROR025) ≥ 1 were defined as the adverse drug reaction signal detection.

Results: In the database, with the following MedDRA terms « nightmare » and « abnormal dreams », 50928 and 37082 notifications were identified respectively. Daridorexant was associated with an overreporting of nightmare (IC025= 6.2, ROR025= 108.7) versus zopiclone (IC025= 3.2, ROR025= 9.6) and oxazepam (IC025= 2.0, ROR025= 4.1). A higher signal of abnormal dreams was noted with daridorexant (IC025= 5.5, ROR025= 62.3) compared to zopiclone (IC025= 0.2, ROR025= 1.2). Contrary to daridorexant, no signal for abnormal dream was identified for oxazepam (IC025= -1.1, ROR025= 0.5).

Conclusions: Daridorexant might increase the risk of reporting sleep disorders compared to the pharmacological treatments classically used. Sleep disturbances can lead to personal and social complications. Today, we have no data comparing daridorexant to the pharmacological medications used in the treatment of insomnia. More studies on daridorexant are needed to further determine the efficacy/adverse effects ratio, comparatively with the other treatment used in insomnia.