NCT05597020

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

A Multi-center, Double-blind, Randomized, Placebo-controlled, 2-way Cross-over Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia

Conditions

• Insomnia Disorder
• Nocturia

Interventions

Type	Name	Description
DRUG	Daridorexant	Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
DRUG	Placebo	Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.

Timeline

• Start date: 2023-02-16
• Primary completion: 2024-04-12
• Completion: 2024-04-18
• First posted: 2022-10-27
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

16 sites across 3 countries: United States, Germany, Spain

Regulatory

• FDA-regulated drug study