Suvorexant for Postoperative Delirium
(REPOSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called suvorexant (Belsomra) to determine if it can improve sleep and reduce confusion after surgery. The study targets adults aged 65 and older undergoing non-heart-related surgeries with an overnight hospital stay. Participants must speak English and not regularly use sleep aids before surgery. The trial includes two groups: one receiving suvorexant and the other a placebo (a harmless pill with no active drug). As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires you to stop taking certain medications, such as sedating sleep aids and moderate or strong CYP3A inhibitors or inducers, at least one week before surgery. If you are taking any of these, you may need to stop or adjust them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that suvorexant is generally safe for use. In a study with 203 participants, those who took suvorexant experienced less delirium (serious confusion) than those who did not. Specifically, only 17% of the suvorexant group experienced delirium, compared to 26% of the placebo group.
Other studies, including those from Japan, support these findings. They suggest that suvorexant may help prevent delirium in hospitalized patients. These studies also found that suvorexant is well-tolerated, with no major safety issues reported during the treatment period.
Overall, this evidence suggests that suvorexant is safe for older adults and can effectively reduce delirium.12345Why do researchers think this study treatment might be promising for delirium?
Suvorexant is unique because it works by targeting orexin receptors in the brain, which play a key role in regulating sleep and wakefulness. Unlike other treatments for postoperative delirium, which often rely on antipsychotics or benzodiazepines that can have undesirable side effects, suvorexant offers a different approach by promoting natural sleep cycles. Researchers are excited about its potential to reduce delirium by improving sleep quality without the sedative effects associated with more traditional medications. This novel mechanism could provide a safer and more effective option for managing postoperative delirium.
What evidence suggests that suvorexant might be an effective treatment for postoperative delirium?
Research has shown that suvorexant, which participants in this trial may receive, might help reduce serious confusion, known as delirium, after surgery, especially in older adults. One study found that 17% of patients who took suvorexant experienced delirium, compared to 26% who took a placebo, a substance with no active ingredients. Another analysis indicated that suvorexant could lower the risk of delirium in hospitalized patients. Additionally, drugs like suvorexant that help regulate sleep have demonstrated a 40%–46% decrease in the occurrence of delirium in some studies. These findings suggest that suvorexant could improve sleep and reduce the risk of delirium for those recovering from surgery.15678
Who Is on the Research Team?
Michael Devinney Jr, MD, PhD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for adults aged 65 and older who are English-speaking, scheduled for non-cardiac surgery with an overnight stay, and can consent to participate. Excluded are those with a BMI over 40, severe sleep apnea, certain psychotic disorders, liver failure, or using specific medications that affect suvorexant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Assessment
Participants complete questionnaires, thinking and memory tests, attention tests, and pupil size measurements. A blood sample is collected.
Treatment
Participants receive either suvorexant or placebo for the first three nights after surgery. Sleep quality and delirium tests are conducted.
Postoperative Monitoring
Participants' sleep quality and delirium severity are assessed daily until postoperative day 5 or hospital discharge.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including hospital length of stay and follow-up visit.
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Suvorexant
Suvorexant is already approved in United States, Japan for the following indications:
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance
- Insomnia characterized by difficulties with sleep onset and/or sleep maintenance
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University