Clinical Trial

Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems

Completed Phase 2
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Summary
Sleep disturbance poses significant in patients with liver cirrhosis and is associated with impaired quality of life and worsening clinical status. Current pharmacological options remain limited and often have safety concerns due to altered hepatic metabolism. Lemborexant, a dual orexin receptor antagonist, promotes physiological sleep by inhibiting orexin-mediated wakefulness pathways. This study aims to evaluate the efficacy and safety of lemborexant for improving sleep in patients with liver cirrhosis.
Trial Details
NCT Number NCT07480096
Lead Sponsor Indonesia University
Conditions Cirrhosis, Liver Cirrhosis, Sleep Quality, Insomnia, Hepatic Encephalopathy
Enrollment 82 participants
Start Date 2024-10-01
Primary Completion 2025-10-30 (estimated)
Study Completion 2025-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-18