# Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

> **NCT03545191** · PHASE3 · COMPLETED · sponsor: **Idorsia Pharmaceuticals Ltd.** · enrollment: 930 (actual)

## Conditions studied

- Insomnia Disorder

## Interventions

- **DRUG:** Daridorexant 25 mg
- **DRUG:** Daridorexant 50 mg
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT03545191
- **Lead sponsor:** Idorsia Pharmaceuticals Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-06-04
- **Primary completion:** 2020-01-25
- **Final completion:** 2020-02-25
- **Target enrollment:** 930 (ACTUAL)
- **Last updated:** 2022-03-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03545191

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03545191, "Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT03545191. Licensed CC0.

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