Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients
Key facts
- Who runs it
- Mayo Clinic
- Where
- Rochester, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 4
- Started
- 26 Feb 2025
- Ended
- 24 Apr 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Best Practice
- Electronic Health Record Review
- Interview
- Questionnaire Administration
- Suvorexant
- Record updated
- 1 May 2025
- Why it stopped
- low/slow accrual
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Presence of advanced active malignancy and insomnia despite nonpharmacologic management
- Anticipated hospital course of at least 3 days post randomization as judged by the patient's primary inpatient team
- One or more of the following risk factors of delirium:; Age 75 or above; Hearing impairment; Vision impairment; Initiation of 8 or new medications since start of hospitalization; Chronic kidney disease III or greater; Congestive heart failure; Hospitalization for 14 or more days; Dehydration requiring ongoing use of intravenous (IV) hydration; Electrolyte imbalance requiring ongoing correction
Who cannot take part
- Current or prior delirium in the active hospitalization
- Concurrent use of strong/moderate CYP3A4 inducers and inhibitors (including but not limited to -azole antifungals, amiodarone, phenytoin, carbamazepine, etc.)
- Use of any benzodiazepine, benzodiazepine receptor modulator, or first generation antihistamine class medication within 72 hours prior to enrollment
- Personal history of narcolepsy
- Personal history of other primary sleep disorders including obstructive sleep apnea
- Personal history of alcohol use disorder
- Personal history of substance use disorder
- Personal history of cirrhosis
- History of obstructive lung disease other than asthma
- Women of childbearing potential (defined as women under age 55 without a personal history of surgical or chemotherapy-induced sterility)
- Inability to consent
- Current pregnancy
- Transaminitis more than 3 times the upper limit of normal
Where in United States
- Mayo Clinic in RochesterRochester, United StatesNo longer taking part
About the trial
What the trial wants to find out
This phase IV trial compares suvorexant with standard of care to standard of care alone for improving difficulty sleeping (insomnia) and reducing confusion (delirium) in hospitalized cancer patients. Delirium can lengthen hospitalization, increase the delay of cancer treatment and can even increase the risk of premature death. Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness. Giving suvorexant with standard of care to treat insomnia may be more effective compared to standard of care alone in reducing the development of delirium in hospitalized cancer patients.
The 2 groups in the trial
- Arm I (suvorexant, standard of care)Treatment being tested
Patients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
Treatment: Best Practice, Electronic Health Record Review, Interview, Questionnaire Administration, and Suvorexant
- Arm II (standard of care)Existing treatment, for comparison
Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
Treatment: Best Practice, Electronic Health Record Review, Interview, and Questionnaire Administration
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Pilot Randomized, Open Label Trial of Orexin Receptor Antagonist for Insomnia in Hospitalized Patients With Cancer to Prevent Delirium
- Record updated
- 1 May 2025