drugset

drugset / Trial / NCT05458193

A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep

NCT05458193 ↗

Phase 1 Completed 20 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedCrossoverQuadruple-blindOther

Summary

A study on the effects of daridorexant on nighttime respiratory function in patients with severe obstructive sleep apnea (OSA).

Timeline

Start: 2022-08-17
Primary completion: 2023-02-28
Completion: 2023-02-28

Outcome

Met primary endpoint

paper Treatment differences were -3.7 events/h (one-sided 95% CI≤+4.2) PMID 42171662 ↗

paper No clinically meaningful effect of daridorexant on AHI or SpO2 during TST was detected. PMID 42171662 ↗

Publications

Fietze I, Boof ML, Lederer K, Lemoine V, Vaillant C, Pepin JL. Daridorexant in severe obstructive sleep apnea: Effects on sleep-disordered breathing and sleep. Sleep. 2026 May 22:zsag145. doi: 10.1093/sleep/zsag145. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daridorexant	Small molecule	50 mg	Oral

Indications