NCT07028697

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Nxera Pharma Korea Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	Daridorexant	Daridorexant will be taken orally, once daily in the evening as indicated by investigator.
DRUG	Placebo	Placebo will be taken orally, once daily in the evening as indicated by investigator.

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-09-23
• Completion: 2025-10-21
• First posted: 2025-06-19
• Last updated: 2026-01-21

Locations

17 sites across 1 country: South Korea