Trial reportAlimentary pharmacology & therapeutics2026
Clinical Trial: Lemborexant Efficacy and Safety in Liver Cirrhosis-Randomized, Double-Blind, Crossover Clinical Trial.
Trial report in Alimentary pharmacology & therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07480096 (Safety and Efficacy of Lemborexant for Patients With Cirrhosis and Sleep Problems), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety and Efficacy of Lemborexant for Patients With Cirrhosis and Sleep Problems: a Randomized Clinical Trial
Who cites it
1 citing paper in PubMed.
- Clinical Trial: Lemborexant Efficacy and Safety in Liver Cirrhosis-Randomized, Double-Blind, Crossover Clinical Trial.Alimentary pharmacology & therapeutics · 2026Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
BACKGROUND AND
aimNo pharmacologic treatment has yet been approved for sleep disturbances in cirrhosis, a high-risk group with substantial prevalence and clinical consequences. Lemborexant has shown efficacy for insomnia, but evidence in cirrhosis is limited.
methodsRestoring Sleep in End-Stage Liver Disease (RESTORE) is a prospective, double-blind, placebo-controlled, crossover trial of Lemborexant for patients with cirrhosis in Cipto Mangunkusumo National Referral Hospital. We randomized 82 patients into three arms: Placebo (n = 28), 5 mg Lemborexant (n = 28), and 10 mg Lemborexant (n = 26). Efficacy was assessed via Pittsburgh Sleep Quality Index (PSQI) over a 2-week period. Safety was evaluated using the EncephalApp Stroop Test for hepatic encephalopathy and liver function tests including AST, ALT, and total bilirubin. PSQI was reevaluated post-crossover at week 4 to investigate rebound insomnia.
resultsLemborexant significantly reduced PSQI at week 2 in both 5 mg (MD: -7.0 ± 3.15; p < 0.001) and 10 mg groups (MD: -8.27 ± 2.68; p < 0.001), indicating better sleep quality. The 5 mg group showed improved Stroop Test reaction time (MD: -23.5 ± 31.3; p < 0.001), suggesting better cognitive function, whereas 10 mg showed a mild but significant increase in reaction time (MD: 16.7 ± 41.3; p = 0.048). Liver function was not different across treatment groups. Post-crossover analysis showed persistent low PSQI scores in active groups who were switched to placebo. Patients who initially received placebo demonstrated improved sleep after receiving Lemborexant.
conclusionOur study supported the efficacy and safety of Lemborexant, particularly at 5 mg, against sleep problems in cirrhosis. Larger studies with longer follow-up are warranted to strengthen evidence. CLINICALTRIALS: gov: NCT07480096.
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