Suvorexant trial to evaluate reduced nighttime wakefulness and delirium in cardiac ICU patients

Postoperative insomnia and delirium are common and debilitating complications in cardiac intensive care unit (ICU) patients, particularly after major surgeries like coronary artery bypass graft (CABG). These conditions prolong hospital stays, increase morbidity, and negatively impact long-term cognitive function. Current management often involves sedatives that can paradoxically worsen delirium or suppress restorative sleep architecture. Orexins are neuropeptides crucial for wakefulness, and their inhibition promotes slow-wave sleep. Suvorexant, an orexin receptor antagonist, offers a targeted approach to improve sleep quality without broad sedative effects, potentially mitigating both insomnia and delirium in this vulnerable population.

This Phase 4, randomized, placebo-controlled trial will enroll 92 adult cardiac surgical patients (≥60 years old) undergoing CABG, with or without valve surgery. Participants receive either oral suvorexant or placebo for 7 nights, starting after extubation. Primary endpoint: nighttime wakefulness after persistent sleep onset (WASO), measured by EEG (SedLine monitor) during the first ICU night. Secondary outcomes include total sleep time (TST), time to sleep onset (TSO), postoperative delirium, and delirium-free days.

This record describes a study protocol (NCT05823844) for a Phase 4 clinical trial. As of the current date, the study status is "UNKNOWN" and results have not yet been published. Therefore, no findings or specific numerical outcomes are available from this abstract. The trial is estimated to complete in May 2025, at which point data on suvorexant's efficacy in reducing WASO, improving other sleep parameters, and impacting postoperative delirium in cardiac ICU patients will be assessed.