Can a sleep drug help cirrhosis patients rest and think clearer?

NCT ID NCT07830303

NEW Symptom relief Sponsor: Wang Fengmei Source: ClinicalTrials.gov ↗

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Many people with liver cirrhosis struggle with poor sleep, which can affect daily life and thinking. This trial tests daridorexant, a sleep medication, against placebo in 180 adults with cirrhosis and sleep disturbance, including some with mild hepatic encephalopathy. Participants take either daridorexant or placebo for 30 days while researchers measure sleep efficiency, sleep quality, and cognitive function. The goal is to see whether daridorexant improves sleep better than placebo and whether it is safe for this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: daridorexant, a dual orexin receptor antagonist sleep medication
What this could lead to: If it works, daridorexant could offer a targeted sleep treatment for people with cirrhosis, whose sleep problems often go unaddressed. Better sleep might also ease the mild thinking difficulties that can accompany liver disease.
What could go wrong: This is a 30-day study of 180 people, so it cannot show long-term benefits or rare side effects. Daridorexant may not improve sleep more than placebo in this group, and people with more advanced liver disease are not included.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-60 years. 2. Confirmed liver cirrhosis based on imaging, pathology, or clinical diagnosis. 3. 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. 4. 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. 5. Provision of written informed consent. Exclusion Criteria: 1. Age \<18 years or \>60 years. 2. Child-Pugh class C liver function. 3. Overt hepatic encephalopathy of West-Haven grade II or higher. 4. Concomitant use of strong CYP3A4 inhibitors, such as itraconazole or ketoconazole, or strong CYP3A4 inducers, such as carbamazepine or rifampin. 5. Severe respiratory insufficiency or uncontrolled severe obstructive sleep apnea. 6. Pregnancy or breastfeeding. 7. Narcolepsy. 8. Known hypersensitivity to daridorexant or any of its excipients. 9. Concomitant use of central nervous system depressants, including alcohol, benzodiazepines, or opioids, that may increase sedation or somnolence. 10. Active severe psychiatric disorders, such as depression with suicidal ideation or a history of suicidal ideation, or a history of substance abuse. 11. Any contraindication to daridorexant.

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver hepatic encephalopathy insomnia Parasomnias sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatic encephalopathy Liver cirrhosis Sleep disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can a sleep drug help cirrhosis patients rest and think clearer?

What the study statuses mean