65 and older, any sex, with Insomnia Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2Primary· Baseline to Day 1 and Day 2 of each treatment period
WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Group
Value
95% CI
ACT-541468 5 mg
-18.9
± 4.44
ACT-541468 10 mg
-32.0
± 4.50
ACT-541468 25 mg
-45.1
± 4.47
ACT-541468 50 mg
-61.4
± 4.44
Placebo
-13.6
± 4.50
Change in Mean Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2Secondary· Baseline to Day 1 and Day 2 of each treatment period
LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Group
Value
95% CI
ACT-541468 5 mg
-37.92
± 48.76
ACT-541468 10 mg
-44.61
± 41.28
ACT-541468 25 mg
-44.81
± 41.56
ACT-541468 50 mg
-44.88
± 44.22
Placebo
-33.88
± 41.74
Adverse events — posted to ClinicalTrials.gov
Time frame: Start of screening until the end of the safety follow-up period..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluates the dose response of ACT-541468 on the change of wake after sleep onset (WASO) assessed by polysomnography (PSG) on the first 2 days of each treatment period.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04024332 — Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Co
· Phase 1
· completed
NCT03892902 — A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderl
· Phase 1
· completed
NCT03765294 — A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obs
· Phase 1
· completed
NCT03799978 — A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
· Phase 1
· completed
NCT03646864 — A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Dis
· Phase 1
· completed
Other recruiting trials for Insomnia Disorder
Currently open trials in the same condition.
NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia
· NA
· recruiting
NCT06626048 — Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study
· NA
· active not recruiting
NCT06669507 — The Sleep Clinic Outcome and Practice Study
· NA
· recruiting
NCT06335784 — Mental Imagery and Targeted Memory Reactivation in Insomnia
· NA
· recruiting
NCT05924425 — Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
· Phase 4
· recruiting
Other Idorsia Pharmaceuticals Ltd. trials
Trials by the same sponsor.
NCT06799884 — A Drug-drug Interaction Trial in Healthy Female Participants to Investigate the Effect of Aprocitentan on Combined Hormo
· Phase 1
· completed
NCT05877222 — A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in
· Phase 1
· completed
NCT05597020 — A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia
· Phase 4
· completed
NCT05632393 — A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
· Phase 1
· completed
NCT05702177 — A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Idorsia Pharmaceuticals Ltd.
Last refreshed: 24 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02841709.