Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

Description

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

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Study Overview

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Study Details

Study overview

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.

A Pilot Randomized, Open Label Trial of Orexin Receptor Antagonist for Insomnia in Hospitalized Patients With Cancer to Prevent Delirium

Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

Condition
Advanced Malignant Solid Neoplasm
Intervention / Treatment

-

Contacts and Locations

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Regina M. Mackey, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2026-05-06