Suvorexant Phase IV trial targets **delirium prevention** and **insomnia improvement** in hospitalized cancer patients.

Delirium is a severe neurocognitive dysfunction common in hospitalized cancer patients, leading to prolonged stays, delayed cancer treatments, and increased mortality risk. Current standard-of-care often falls short in preventing or managing this acute confusional state, particularly in vulnerable populations. Suvorexant, an orexin receptor antagonist, offers a novel approach by blocking wakefulness-promoting orexin signaling in the brain, thereby improving sleep architecture. This mechanism is hypothesized to mitigate sleep disturbances, a known instigator of delirium, addressing a critical unmet need in oncology supportive care.

This multi-site, parallel-group, randomized, double-blind, placebo-controlled Phase IV clinical trial is designed to assess the efficacy and safety of suvorexant in hospitalized cancer patients. Participants will receive either suvorexant or placebo. The treatment arm begins with 10mg suvorexant orally (po) at bedtime (qhs) for two nights, followed by an increase to 20mg for a 14-day active treatment period. The primary endpoints include improvements in difficulty sleeping (insomnia) and a reduction in the incidence of delirium, compared to standard of care alone.

This ongoing Phase IV trial aims to demonstrate that suvorexant significantly reduces the development of delirium and improves sleep quality in hospitalized cancer patients. Researchers hypothesize that blocking orexin signaling will lead to a measurable decrease in delirium incidence, potentially by improving sleep continuity and reducing sleep fragmentation. The trial seeks to show that patients receiving suvorexant will experience a lower rate of delirium compared to the placebo group, alongside reported improvements in subjective and objective sleep parameters. While specific numerical results are not yet available from this ongoing trial, the design targets statistically significant improvements in these key clinical outcomes.

The primary objective is to establish whether suvorexant can effectively prevent delirium, a critical complication that currently lacks targeted pharmacological prevention strategies, thereby improving overall patient outcomes. Secondary objectives include assessing the impact on hospitalization duration, the timeliness of cancer treatment initiation, and overall mortality rates, with the expectation of positive effects in these areas if delirium is successfully mitigated.