The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Last updated: June 20, 2024
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

4

Condition

Spondylolisthesis

Treatment

Placebo

Zolpidem Tartrate 10 mg

Clinical Study ID

NCT05746143
HS-22-00529
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • degenerative lumbar disease

  • age of 18-75

  • undergoing open primary one- to three-level lumbar fusion

Exclusion

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 inflammatoryspondyloarthropathy

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
February 01, 2022
Estimated Completion Date:
December 31, 2027

Study Description

Patients who are undergoing one- to three-level spinal fusion for degenerative lumbar disease will be recruited. They will be randomized to either receive zolpidem or placebo two days preoperatively and five days postoperatively.

Connect with a study center

  • Keck Medical Center of USC

    Los Angeles, California 90033
    United States

    Active - Recruiting

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