The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Spine Fusion; Lumbar Spine Degeneration; Lumbar Spine Spondylosis
• Intervention / Treatment: Drug: Zolpidem Tartrate 10 mg; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pui Yan, MS; Phone Number: 323-442-6984; Email: puiyan@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Keck Medical Center of USC
      • Contact: Pui Yan, MS; Phone Number: 323-442-6984; Email: puiyan@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; two days preoperatively and five days postoperatively
Experimental: Zolpidem	Drug: Zolpidem Tartrate 10 mg; two days preoperatively and five days postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS)	Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)	Postoperative day five

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	Patient reported outcome with regard to low back pain and function; score range: 0-100%, higher scores = higher disability from low back pain (worse outcome)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Morphine Equivalents	values that represent the potency of an opioid dose relative to morphine	Postoperative day one, two, three, four, five, and two weeks
Quality of Recovery - 40 (QoR-40) questionnaire	Patient Reported Outcome; score range: 40-200, higher score = greater recovery (better outcome)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Epworth Sleepiness Score (ESS)	Patient Reported Outcome; score range: 0-24; higher score = greater daytime sleepiness (worse outcome)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Pain Catastrophizing Scale (PCS)	Patient Reported Outcome; scale range: 0-24, higher score = higher pain catastrophizing (worse outcome)	Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Hospital Length of Stay		Postoperative two-weeks
Postoperative complications		Postoperative two-years
Visual analog scale (VAS)	Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)	preoperative, postoperative day one, three, as well as two weeks and six weeks

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Zolpidem; Lumbar Spine Fusion; Postoperative Outcomes
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Zolpidem
• Other Study ID Numbers: HS-22-00529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No