Efficacy and Safety of Lemborexant for Patients With Cirrhosis and Sleep Problems

NCT07480096 | Completed Phase 2

• 1 other identifier: 24-11-1690
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Liver Cirrhosis; Sleep Quality; Insomnia; Hepatic Encephalopathy

Keywords

cirrhosis; liver; sleep; orexin; lemborexant; insomnia; sleep quality; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  PSQI score

  From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (3)

• Hepatic Encephalopathy - Stroop Test

  From enrollment to the end of treatment at 2 weeks

• Liver function tests

  From enrollment to the end of treatment at 2 weeks

• Persistence of effects (sleep quality)

  PSQI changes post-crossover at week 2 - week 4

Study Arms (3)

5 mg lemborexant

EXPERIMENTAL

Lemborexant 5 mg orally once nightly before bedtime

Drug: Lemborexant

10 mg lemborexant

EXPERIMENTAL

Lemborexant 10 mg orally once nightly before bedtime

Drug: Lemborexant

Placebo

PLACEBO COMPARATOR

Placebo orally once nightly before bedtime

Drug: Placebo

Interventions

Lemborexant DRUG

Lemborexant 5 mg orally once nightly before bedtime/ Lemborexant 10 mg orally once nightly before bedtime,

10 mg lemborexant; 5 mg lemborexant

Placebo DRUG

Matching placebo taken orally once nightly before bedtime.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged 18 years or older;
• willingness to participate in the clinical trial as evidenced by written informed consent; documented diagnosis of liver cirrhosis in the medical record, with disease severity assessed using the Child-Pugh score and supported by imaging findings consistent with cirrhosis on FibroScan or ultrasonography;
• presence of sleep disturbance defined by a Pittsburgh Sleep Quality Index (PSQI) score greater than 5;
• patients receiving inpatient or outpatient care at Cipto Mangunkusumo National General Hospital;
• ability to take oral medication;
• willingness of the patient or caregiver to maintain a sleep diary throughout the study period;
• ability of the patient or caregiver to comply with the clinical trial protocol and complete scheduled serial assessments.

You may not qualify if:

• advanced liver cirrhosis defined as Child-Pugh class C;
• current use of medications with significant interactions affecting the metabolism of Lemborexant, including itraconazole, clarithromycin, fluconazole, verapamil, tramadol, rifampicin, carbamazepine, bosentan, efavirenz, etravirine, and modafinil;
• ongoing alcohol consumption or intake of grapefruit juice during the study period;
• pregnancy, breastfeeding, or plans to become pregnant during the study;
• presence of significant comorbid conditions such as autoimmune disease,
• stage V chronic kidney disease, HIV/AIDS, or known or suspected hypersensitivity to the investigational drug;
• concurrent participation in another clinical trial at the time of screening.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (3)

• Marjot T, Ray DW, Williams FR, Tomlinson JW, Armstrong MJ. Sleep and liver disease: a bidirectional relationship. Lancet Gastroenterol Hepatol. 2021 Oct;6(10):850-863. doi: 10.1016/S2468-1253(21)00169-2. Epub 2021 Jul 15.

  PMID: 34273289 BACKGROUND

• Karppa M, Yardley J, Pinner K, Filippov G, Zammit G, Moline M, Perdomo C, Inoue Y, Ishikawa K, Kubota N. Long-term efficacy and tolerability of lemborexant compared with placebo in adults with insomnia disorder: results from the phase 3 randomized clinical trial SUNRISE 2. Sleep. 2020 Sep 14;43(9):zsaa123. doi: 10.1093/sleep/zsaa123.

  PMID: 32585700 BACKGROUND

• Rosenberg R, Murphy P, Zammit G, Mayleben D, Kumar D, Dhadda S, Filippov G, LoPresti A, Moline M. Comparison of Lemborexant With Placebo and Zolpidem Tartrate Extended Release for the Treatment of Older Adults With Insomnia Disorder: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1918254. doi: 10.1001/jamanetworkopen.2019.18254.

  PMID: 31880796 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Liver Cirrhosis; Sleep Initiation and Maintenance Disorders; Hepatic Encephalopathy

Interventions

lemborexant

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Liver Failure; Hepatic Insufficiency; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rino Alvani Gani, Professor, Internist, MD

  Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta

  PRINCIPAL INVESTIGATOR

• Pitt Akbar, MD, Internist

  Hepatobiliary Division, Internal Medicine Department, Dr Cipto Mangunkusumo National General Hospital, Faculty of Medicine Universitas Indonesia, Jakarta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Hepatologist, Internist

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: October 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: Data will be available to investigators whose proposed use of the data has been approved by the study investigators following submission of a methodologically sound research proposal and completion of a data-sharing agreement.

Locations

ID (1)