Clinical trial · Interventional
Suvorexant for Insomnia to Prevent 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low/slow accrual
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Delirium | — | UNRESOLVED | — |
| Hematopoietic and Lymphatic System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Suvorexant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (suvorexant, standard of care)
- description
- 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.
- interventionNames
- Other: Best Practice
- Other: Electronic Health Record Review
- Other: Interview
- Other: Questionnaire Administration
- Drug: Suvorexant
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard of care)
- description
- Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
- interventionNames
- Other: Best Practice
- Other: Electronic Health Record Review
- Other: Interview
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available