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Orexin Receptor Antagonist

Suvorexant for Sleep Disturbance

Phase 4

Recruiting

Led By Paul S. Garcia, MD PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 50 years to 90 years old

Patients getting elective surgeries for orthopedic reasons (e.g., hip or knee replacement), abdominal surgery (e.g., hernia repair, renal cancer), urologic or gynecologic surgery, and spine surgery with a projected inpatient stay of 24 hours or longer

Must not have

Chronic pain (i.e., patients on opioid medications as an outpatient)

Intra-cranial surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 5 post-surgery

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests a drug to help people sleep during hospital stays. It is double-blind and randomized to see if the drug is effective.

Who is the study for?

This trial is for people aged 50-90 who are having elective surgeries like hip replacement or hernia repair and have had trouble sleeping at least three times a week over the last three months. It's not for those with severe sleep apnea, chronic pain, certain heart surgeries, mental health issues, dementia, or taking drugs that affect Suvorexant.

What is being tested?

The study tests if Suvorexant helps with sleep problems after surgery compared to a placebo. Participants will be randomly assigned to either get Suvorexant (20 mg reducing to 10 mg if needed) or placebo pills during their hospital stay.

What are the potential side effects?

Possible side effects of Suvorexant include daytime sleepiness which may lead to a lower dose being administered. Other potential side effects aren't specified but could align with common sleep aid reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 90 years old.

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I am scheduled for surgery (like hip replacement or hernia repair) with a hospital stay of at least 24 hours.

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I have had trouble falling asleep or staying asleep at least 3 nights a week for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take opioid medication for ongoing pain.

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I have had brain surgery.

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I have severe sleep apnea.

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I have had heart surgery, such as a bypass.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 5 post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 5 post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 5 post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total sleep time on day 0 (TST)

Secondary study objectives

Incidence of Delirium

Longitudinal trend of TST

Rate of attrition

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Suvorexant administrationExperimental Treatment1 Intervention

Subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes, each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).

Group II: Placebo administrationPlacebo Group1 Intervention

Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Suvorexant

2016

Completed Phase 4

~2200

0 / 7Eligibility criteria met