Spine FusionPhase 4NCT05746143
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
A Phase 4 study testing Zolpidem Tartrate 10 mg in people with Spine Fusion and Lumbar Spine Degeneration, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spine Fusion, Lumbar Spine Degeneration, Pain, Postoperative
- What is being tested?
- Zolpidem Tartrate 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- degenerative lumbar disease
- age of 18-75
- undergoing open primary one- to three-level lumbar fusion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Keck Medical Center of USC
Los Angeles, California, 90033
Pui Yan, MS, 323-442-6984, puiyan@med.usc.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Zolpidem Tartrate 10 mg, Placebo
- Keywords
- Lumbar Spine Fusion, Zolpidem, Postoperative Outcomes
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolpidem Tartrate 10 mgDrug
two days preoperatively and five days postoperatively
PlaceboDrug
two days preoperatively and five days postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem | Experimental | Not described Receives: Drug: Zolpidem Tartrate 10 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)
Measured: Postoperative day five
Secondary outcomes (8)
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Hospital Length of Stay
Measured: Postoperative two-weeks
Postoperative complications
Measured: 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)
Measured: preoperative, postoperative day one, three, as well as two weeks and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Feb 2022
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Hah, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746143
- Sponsor's protocol ID
- HS-22-00529
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2023
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05746143
- Acronym / sponsor ID
- HS-22-00529
- Keywords
- Lumbar Spine Fusion, Zolpidem, Postoperative Outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zolpidem | Experimental | Drug: Zolpidem Tartrate 10 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- degenerative lumbar disease
- age of 18-75
- undergoing open primary one- to three-level lumbar fusion
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolpidem Tartrate 10 mgtwo days preoperatively and five days postoperatively | Drug | Zolpidem |
| Placebotwo days preoperatively and five days postoperatively | Drug | Placebo |
Primary outcome
Visual analog scale (VAS)
Time frame: Postoperative day five
Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)
8 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Morphine Equivalents
Time frame: Postoperative day one, two, three, four, five, and two weeks
Quality of Recovery - 40 (QoR-40) questionnaire
Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Epworth Sleepiness Score (ESS)
Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Pain Catastrophizing Scale (PCS)
Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks
Hospital Length of Stay
Time frame: Postoperative two-weeks
Postoperative complications
Time frame: Postoperative two-years
Visual analog scale (VAS)
Time frame: preoperative, postoperative day one, three, as well as two weeks and six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zolpidem Tartrate 10 mg in people with Spine Fusion and Lumbar Spine Degeneration, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pui Yan, MS (323-442-6984, puiyan@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: Postoperative day five). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.