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Sedative

Zolpidem for Spinal Fusion Recovery

N/A
Recruiting
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of 18-75
Patients with degenerative lumbar disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative two-years
Awards & highlights

Study Summary

This trial will test if a drug (zolpidem) helps improve recovery after spinal fusion surgery. #medicine

Who is the study for?
This trial is for adults aged 18-75 with degenerative lumbar disease who are having a one- to three-level open primary lumbar fusion surgery. It's not for those with lumbar issues due to fracture, infection, tumor, or inflammatory conditions; current nightly sleep aid users; people with insomnia or sleep apnea; history of delirium from opiates or zolpidem; allergies to these drugs; previous lumbar spine surgeries; or undergoing minimally invasive surgery.Check my eligibility
What is being tested?
The study tests if Zolpidem Tartrate (10 mg), taken around the time of posterior lumbar spinal fusion surgery, can improve patient outcomes compared to a placebo. Patients' reported postoperative pain and recovery quality will be measured.See study design
What are the potential side effects?
Zolpidem may cause drowsiness, dizziness, weakness, feeling 'drugged' or light-headedness the day after use. Some might experience confusion, agitation, hallucinations especially in older adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have a degenerative condition in my lower back.
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I am having surgery to fuse 1-3 bones in my lower back.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative two-years
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative two-years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Epworth Sleepiness Score (ESS)
Hospital Length of Stay
Morphine Equivalents
+5 more

Side effects data

From 2010 Phase 2 & 3 trial • 192 Patients • NCT00770510
4%
Dizziness
4%
Somnolence
1%
Dysgeusia
1%
Dermatitis Contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
Zolpidem Tartrate 10 mg
Eszopiclone 1 mg
Eszopiclone 2 mg
Eszopiclone 3 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ZolpidemExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zolpidem Tartrate 10 mg
2008
Completed Phase 3
~200

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
914 Previous Clinical Trials
1,602,806 Total Patients Enrolled

Media Library

Zolpidem Tartrate 10 mg (Sedative) Clinical Trial Eligibility Overview. Trial Name: NCT05746143 — N/A
Spinal Fusion Research Study Groups: Zolpidem, Placebo
Spinal Fusion Clinical Trial 2023: Zolpidem Tartrate 10 mg Highlights & Side Effects. Trial Name: NCT05746143 — N/A
Zolpidem Tartrate 10 mg (Sedative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746143 — N/A
Spinal Fusion Patient Testimony for trial: Trial Name: NCT05746143 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study permit the enrollment of individuals over thirty years old?

"This medical trial has a minimum age requirement of 18 years, and is not open to participants aged over 75."

Answered by AI

Are there any specific criteria for eligibility to partake in this clinical trial?

"This medical trial is currently recruiting 140 individuals suffering from postoperative pain, aged between 18 and 75 with degenerative lumbar disease. Furthermore, these participants must also have undergone open primary one- to three-level lumbar fusion."

Answered by AI

Is enrollment open for this experiment?

"The clinical trial has been available for recruitment since February 1, 2022 and was recently updated on February 22nd 2023. Fortunately, this medical study is still actively seeking patients according to the details provided by clinicaltrials.gov."

Answered by AI

How many participants are currently undergoing treatment as part of this clinical trial?

"Affirmative. By referencing clinicaltrials.gov, one can ascertain that this experiment is in the current process of recruiting participants. It was initially added on February 1st 2022 and last modified on February 22nd 2023; it seeks to enrol 140 research subjects at a single site."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Keck Medical Center of USC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

To have a healthier pain less life. Years of pain and misinformation regarding pain meds.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
Raymond Hah 2022. "The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05746143.
~43 spots leftby May 2025
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