A Phase 2 interventional study of Lemborexant and Placebo in Cirrhosis, Liver Cirrhosis and Sleep Quality, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Indonesia University · Phase 2, Interventional, and Treatment
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.
Patients with liver cirrhosis frequently experience sleep-wake disturbances such as insomnia, delayed sleep onset, or fragmented sleep. These disturbances may contribute to neurocognitive dysfunction and precipitate hepatic encephalopathy. However, conventional hypnotics such as benzodiazepines may worsen encephalopathy and are generally avoided.
Lemborexant selectively antagonizes orexin receptors OX1R and OX2R, modulating sleep without profound respiratory suppression or GABAergic effects. This randomized, three-armed, double-blind placebo-controlled trial aims to determine whether lemborexant improves sleep quality in patients with cirrhosis while maintaining acceptable neurocognitive and safety outcomes.
3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.
This study's enrollment of 82 is above the median of 50 across 2,130 interventional studies indexed under Fibrosis.
Browse Fibrosis studies →Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Lemborexant 5 mg orally once nightly before bedtime
Drug: Lemborexant
Lemborexant 10 mg orally once nightly before bedtime
Drug: Lemborexant
Placebo orally once nightly before bedtime
Drug: Placebo
Lemborexant 5 mg orally once nightly before bedtime/ Lemborexant 10 mg orally once nightly before bedtime,
Matching placebo taken orally once nightly before bedtime.
Sleep quality
PSQI score
Time frame: From enrollment to the end of treatment at 2 weeks
Hepatic Encephalopathy - Stroop Test
Stroop Test Score
Time frame: From enrollment to the end of treatment at 2 weeks
Liver function tests
Liver function tests including ALT, AST, and total bilirubin levels
Time frame: From enrollment to the end of treatment at 2 weeks
Persistence of effects (sleep quality)
PSQI score
Time frame: PSQI changes post-crossover at week 2 - week 4
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication, including baseline characteristics, as well as efficacy and safety outcome measures.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Indonesia University