Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

NCT06834386 | Withdrawn Phase 4 FDA Drug

• 2 other identifiers: 24-005893NCI-2025-00771
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Solid Neoplasm; Delirium; Hematopoietic and Lymphatic System Neoplasm; Insomnia

Outcome Measures

Primary Outcomes (1)

• Recruitment

  Feasibility will be defined as the ability to recruit 14 patients to the study with 20% or less study attrition.

  Up to 1 year

Secondary Outcomes (2)

• Adherence to standard of care

  Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first

• Change in Insomnia Severity Index score

  Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first

Study Arms (2)

Arm I (suvorexant, standard of care)

EXPERIMENTAL

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.

Other: Best Practice; Other: Electronic Health Record Review; Other: Interview; Other: Questionnaire Administration; Drug: Suvorexant

Arm II (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.

Other: Best Practice; Other: Electronic Health Record Review; Other: Interview; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm I (suvorexant, standard of care); Arm II (standard of care)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (suvorexant, standard of care); Arm II (standard of care)

Interview OTHER

Ancillary studies

Arm I (suvorexant, standard of care); Arm II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (suvorexant, standard of care); Arm II (standard of care)

Suvorexant DRUG

Given PO

Also known as: Belsomra, MK-4305

Arm I (suvorexant, standard of care)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Inability to consent
• Current pregnancy
• Women of childbearing potential (defined as women under age 55 without a personal history of surgical or chemotherapy-induced sterility)
• 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
• Transaminitis more than 3 times the upper limit of normal
• History of obstructive lung disease other than asthma

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Delirium; Sleep Initiation and Maintenance Disorders

Interventions

Practice Guidelines as Topic; Standard of Care; Interviews as Topic; suvorexant

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Regina M. Mackey, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: February 26, 2025
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (1)