Evaluating the impact of zolpidem on recovery after lumbar spine fusion surgery
Official title: The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial
Run by University of Southern California · NCT05746143 · Data updated 2026-11-12
This study is testing if giving a sleep aid called zolpidem to patients having spine surgery can help them recover better and feel less pain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Status | Recruiting |
| Started | February 1, 2022 |
| Main results expected | January 31, 2029 |
| Study ends | December 31, 2030 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT05746143 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 with degenerative lumbar disease who are scheduled for open primary one- to three-level lumbar fusion.
✕Probably not a fit
Patients who regularly use sleep aids, have insomnia or sleep apnea, or have a history of complications with zolpidem or opiates may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess whether administering zolpidem, a sleep aid, around the time of lumbar spine fusion surgery can enhance patient-reported outcomes. Patients aged 18 to 75 with degenerative lumbar disease will be randomly assigned to receive either zolpidem or a placebo starting two days before surgery and continuing for five days post-surgery. The focus is on one- to three-level spinal fusion procedures, and the outcomes will be measured based on patient feedback regarding their recovery and pain levels.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery experiences and outcomes for patients undergoing lumbar spine fusion.
How similar studies have gone: While the use of zolpidem in this context is relatively novel, similar studies exploring the impact of sleep aids on postoperative outcomes have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * degenerative lumbar disease * age of 18-75 * undergoing open primary one- to three-level lumbar fusion Exclusion Criteria: * currently use a sleep aid nightly * diagnosed with insomnia or sleep apnea * history of delirium with opiates or zolpidem * allergic to opiates or zolpidem * had previous lumbar spine surgery * undergoing minimally invasive lumbar fusion, * undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy
Where it's running
-
Keck Medical Center of USC
Los Angeles, California, United States Recruiting
Study contacts
- Study coordinator: Pui Yan, MS
- Email: puiyan@med.usc.edu
- Phone: 323-442-6984
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.