Recruiting

Zolpidem

Sponsor:

University of Southern California

Code:

NCT05746143

Conditions

Spine Fusion

Lumbar Spine Degeneration

Pain, Postoperative

Lumbar Spine Spondylosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Zolpidem Tartrate 10 mg

Placebo

Study Details

Brief summary:

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

Conditions

Spine Fusion

Lumbar Spine Degeneration

Pain, Postoperative

Lumbar Spine Spondylosis

Study ID

NCT05746143

Start date

Feb 1, 2022

Status verified date

Apr, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Zolpidem

placebo comparator: Placebo

Interventions

Zolpidem Tartrate 10 mg

two days preoperatively and five days postoperatively

Placebo

two days preoperatively and five days postoperatively

Primary outcome measure

  • Visual analog scale (VAS) [ Time Frame: Postoperative day five ]

Central Contacts and Locations

Central contacts

Pui Yan, MS

323-442-6984puiyan@med.usc.edu

Locations

Keck Medical Center of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Pui Yan, MS

323-442-6984puiyan@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Lumbar Spine Fusion
  • Zolpidem
  • Postoperative Outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-05-01.