Phase 4
N=100
Suvorexant and Sleep/Delirium in ICU Patients
Insomnia · Sleep Fragmentation · Sleep Initiation and Maintenance Disorders · Postoperative Delirium
Bottom Line
View on ClinicalTrials.gov: NCT04092894 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Nighttime Wakefulness After Persistent Sleep Onset (WASO) — 200.7; 184.2 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Suvorexant 20 mg (Drug); Placebo oral tablet (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nighttime Wakefulness After Persistent Sleep Onset (WASO) |
200.7; 184.2 | — |
| SECONDARY Total Sleep Time (TST) |
224; 253 | — |
Summary
Investigators will evaluate the efficacy of postoperative oral suvorexant treatment on nighttime wakefulness after persistent sleep onset (WASO) among adult cardiac surgical patients recovering in the cardiac intensive care unit (ICU). The study include patients ≥ 60 years old undergoing coronary artery bypass graft surgery (CABG), with or without valve surgery (aortic or mitral). Patients will receive either oral suvorexant or placebo for 7 nights starting the night after extubation. The primary hypothesis is that suvorexant compared with placebo decreases WASO, as measured by a specialized electroencephalogram (EEG), the SedLine monitor, during the first night in the cardiac ICU. Investigators will also assess total sleep time (TST), time to sleep onset (TSO), and postoperative delirium and delirium-free days.
Eligibility Criteria
Inclusion criteria
- Age 60 years or older
- Undergoing elective coronary artery bypass graft surgery with or without aortic and/or mitral valve replacement, who are expected to be transferred to the ICU postoperatively
Exclusion criteria
- Preoperative left ventricular ejection fraction of less than 30%
- Renal failure (creatinine >2 mg/dl or dialysis dependence)
- Liver failure (CHILD-Pugh>4)
- Coma (RASS 40)
- Known or suspected pregnancy (there are no adequate and well-controlled studies of suvorexant in pregnant women. Based on animal data, Suvorexant may cause fetal harm).
- Patients with known hypersensitivity to study medications
- English language limitations (Sleep assessment and delirium assessment tools are only validated in English)
- Patients enrolled in other interventional studies which could confound the primary endpoint.
Data sourced from ClinicalTrials.gov (NCT04092894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.