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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
Lemborexant 5 mg orally once nightly before bedtime/ Lemborexant 10 mg orally once nightly before bedtime,
Matching placebo taken orally once nightly before bedtime.
Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta
Jakarta, DKI Jakarta, Indonesia
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
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