Daridorexant for Sleep Disturbance in Adults With Liver Cirrhosis
Key facts
- Phase
- Phase 4
This trial has no sites in United States.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07830303, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Wang Fengmei
- Trial code
- NCT07830303
- Record updated
- 16 October 2026
- Original description
This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy. Sleep disturbance is common in people with liver cirrhosis and may affect quality of life and cognitive function. Participants will be randomly assigned to receive either daridorexant or a matching placebo for 30 days. Neither participants nor study investigators will know which treatment is assigned during the study, except when unblinding is medically necessary. Sleep and cognitive function will be assessed during the study using sleep monitoring, the Psychometric Hepatic Encephalopathy Score (PHES), and the Stroop EncephalApp, together with other clinical and laboratory assessments. The main purpose of the study is to determine whether daridorexant improves sleep efficiency compared with placebo after 30 days. The study will also evaluate changes in sleep quality, sleep structure, cognitive function, the occurrence or improvement of covert hepatic encephalopathy, and the safety of daridorexant. A total of 180 participants are planned to be enrolled at multiple participating hospitals and will be randomly assigned in a 1:1 ratio to daridorexant or placebo.Read full original descriptionShow less
Efficacy and Safety of a Novel Dual Orexin Receptor Antagonist in Patients With Sleep Disturbance and Hepatic Encephalopathy
This study will evaluate the efficacy and safety of daridorexant, a dual orexin receptor antagonist, in adults with liver cirrhosis and sleep disturbance, including participants with or without covert hepatic encephalopathy. Sleep disturbance is common in people with liver cirrhosis and may affect quality of life and cognitive function. Participants will be randomly assigned to receive either daridorexant or a matching placebo for 30 days. Neither participants nor study investigators will know which treatment is assigned during the study, except when unblinding is medically necessary. Sleep and cognitive function will be assessed during the study using sleep monitoring, the Psychometric Hepatic Encephalopathy Score (PHES), and the Stroop EncephalApp, together with other clinical and laboratory assessments. The main purpose of the study is to determine whether daridorexant improves sleep efficiency compared with placebo after 30 days. The study will also evaluate changes in sleep quality, sleep structure, cognitive function, the occurrence or improvement of covert hepatic encephalopathy, and the safety of daridorexant. A total of 180 participants are planned to be enrolled at multiple participating hospitals and will be randomly assigned in a 1:1 ratio to daridorexant or placebo.
Inclusion: Age 18-60 years; Confirmed liver cirrhosis based on imaging, pathology, or clinical diagnosis; Child-Pugh class A or B liver function; participants with hepatic encephalopathy must have covert hepatic encephalopathy (minimal hepatic encephalopathy [MHE]) or West-Haven grade I hepatic encephalopathy; Insomnia supported by both subjective and objective evidence, including a Pittsburgh Sleep Quality Index (PSQI) total score >5 and objective polysomnography (PSG) or actigraphy findings; Provision of written informed consent.
Exclusion: Concomitant use of strong CYP3A4 inhibitors, such as itraconazole or ketoconazole, or strong CYP3A4 inducers, such as carbamazepine or rifampin; Concomitant use of central nervous system depressants, including alcohol, benzodiazepines, or opioids, that may increase sedation or somnolence; Severe respiratory insufficiency or uncontrolled severe obstructive sleep apnea; Known hypersensitivity to daridorexant or any of its excipients; Active severe psychiatric disorders, such as depression with suicidal ideation or a history of suicidal ideation, or a history of substance abuse; Age <18 years or >60 years; Child-Pugh class C liver function; Overt hepatic encephalopathy of West-Haven grade II or higher; Pregnancy or breastfeeding; Narcolepsy; Any contraindication to daridorexant.