Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients

Inclusion Criteria:

• Presence of advanced active malignancy and insomnia despite nonpharmacologicmanagement

• Anticipated hospital course of at least 3 days post randomization as judged by thepatient'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 personalhistory 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 notlimited to -azole antifungals, amiodarone, phenytoin, carbamazepine, etc.)

• Use of any benzodiazepine, benzodiazepine receptor modulator, or first generationantihistamine 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