Zolpidem for Spinal Fusion Recovery

Phase 4

Recruiting

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Age of 18-75

Patients with degenerative lumbar disease

Must not have

Allergic to opiates or zolpidem

Undergoing minimally invasive lumbar fusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preoperative, postoperative day one, three, as well as two weeks and six weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test if a drug (zolpidem) helps improve recovery after spinal fusion surgery. #medicine

Who is the study for?

This trial is for adults aged 18-75 with degenerative lumbar disease who are having a one- to three-level open primary lumbar fusion surgery. It's not for those with lumbar issues due to fracture, infection, tumor, or inflammatory conditions; current nightly sleep aid users; people with insomnia or sleep apnea; history of delirium from opiates or zolpidem; allergies to these drugs; previous lumbar spine surgeries; or undergoing minimally invasive surgery.

What is being tested?

The study tests if Zolpidem Tartrate (10 mg), taken around the time of posterior lumbar spinal fusion surgery, can improve patient outcomes compared to a placebo. Patients' reported postoperative pain and recovery quality will be measured.

What are the potential side effects?

Zolpidem may cause drowsiness, dizziness, weakness, feeling 'drugged' or light-headedness the day after use. Some might experience confusion, agitation, hallucinations especially in older adults.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have a degenerative condition in my lower back.

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I am having surgery to fuse 1-3 bones in my lower back.

Exclusion Criteria

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

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I am allergic to opiates or zolpidem.

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I am scheduled for a minimally invasive surgery to fuse vertebrae in my lower back.

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I have had surgery on my lower back before.

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I am having spine surgery due to a fracture, infection, cancer, or inflammation.

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I have been diagnosed with insomnia or sleep apnea.

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I use sleep medication every night.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative, postoperative day three, five, as well as two weeks and six weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative, postoperative day three, five, as well as two weeks and six weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative, postoperative day three, five, as well as two weeks and six weeks for reporting.