Lemborexant to help Sleep and Delirium in older ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4, single-center trial will compare lemborexant to placebo in elderly surgical ICU patients who have at least 48 hours of expected stay. The study focuses on sleep quality and delirium outcomes, with safety monitored in a critically ill population. Eligible participants must be able to take medications by mouth or via a tube and meet specific health criteria. The trial aims to determine if this sleep drug can be safely used in the SICU to potentially improve recovery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 65 years or older.
* Admission to the Surgical Intensive Care Unit (SICU).
* Anticipated ICU stay of at least 48 hours, as assessed by the ICU consultant and responsible surgeon.
* Able to receive enteral medication via oral or nasogastric route.

Exclusion Criteria:

* Requirement for frequent neurological checks or scheduled awakening (e.g., acute stroke or neurosurgery).
* Deep sedation defined as Richmond Agitation-Sedation Scale (RASS) ≤ -3.
* Positive Confusion Assessment Method for the ICU (CAM-ICU) within 12 hours prior to randomization.
* Severe hemodynamic or respiratory instability requiring neuromuscular blockers or high-dose vasopressors (e.g., norepinephrine ≥ 0.1 µg/kg/min and titrating upward).
* High risk of aspiration, including ongoing vomiting, gastric residual volume \>250 mL, or intolerance to oral or enteral medications.
* Concomitant use of strong CYP3A inhibitors or inducers (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, rifampicin, carbamazepine, phenytoin, or St. John's wort).
* Severe hepatic impairment (Child-Pugh class C).
* End-stage kidney disease or chronic kidney disease stage 5.
* Concomitant use of sedative-hypnotic medications, including benzodiazepines, Z-drugs, trazodone, tricyclic antidepressants, melatonin, or other sleep-inducing agents.
* Known hypersensitivity to lemborexant or other dual orexin receptor antagonists.
* History of cataplexy-like symptoms or severe depression with suicidal ideation.

Where it's running

• Siriraj Hospital
  Bangkok, Thailand Recruiting

Study contacts

• Principal investigator: Nuanprae Kitisin — Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
• Study coordinator: Nuanprae Kitisin, MD
• Email: nuanprae.kit@mahidol.ac.th
• Phone: +66896767706

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.