Zolpidem for Spinal Fusion Recovery

Overseen By Pui Yan, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Southern California

Must not be taking: Sleep aids

Disqualifiers: Insomnia, Sleep apnea, Delirium, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if zolpidem, a common sleep aid, can enhance recovery after posterior lumbar spinal fusion surgery. The study will compare patients taking zolpidem to those taking a placebo (a pill with no active drug) to assess improvements in post-surgery recovery. Participants with degenerative lumbar disease scheduled for this specific surgery may qualify if they do not regularly use sleep aids or have certain sleep-related conditions. As a Phase 4 trial, zolpidem is already FDA-approved and proven effective, and this research seeks to understand its benefits for a broader patient group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you use a sleep aid nightly, you cannot participate in this study.

What is the safety track record for these treatments?

Research shows that zolpidem, a common sleep aid, is generally safe for people. The FDA has approved it for treating insomnia, indicating it has passed many safety tests.

However, specific safety information about using zolpidem around the time of surgery, such as spinal fusion, is limited. A review examined zolpidem for pain relief after surgery but found limited safety data for this use. While it appears safe, fewer studies focus on its use in this context.

Overall, zolpidem is well-tolerated by many, though some may experience side effects like dizziness or headaches. The study's later phase suggests some confidence in its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for spinal fusion recovery, which often focus on pain management through opioids or NSAIDs, Zolpidem offers a novel approach by enhancing sleep quality. Zolpidem, commonly known as a sleep aid, is being explored for its potential to improve the healing process during spinal fusion recovery by promoting restorative sleep, which is crucial for tissue repair and overall recovery. Researchers are excited about Zolpidem because it could provide a non-opioid alternative that not only aids sleep but also supports faster and possibly more effective recovery.

What evidence suggests that zolpidem might be an effective treatment for spinal fusion recovery?

Research has shown that zolpidem, a sleep aid, can enhance recovery after spinal fusion surgery. Studies have found that taking 10 mg of zolpidem improves sleep quality, which is crucial for healing. Better sleep can lead to improved pain control and quicker recovery. Although zolpidem is already used for sleep issues, this trial will compare its effects with a placebo to assess its impact on recovery after spinal fusion. Evidence suggests that by improving sleep, zolpidem might help patients feel better and recover faster post-surgery. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a degenerative condition in my lower back.

I am having surgery to fuse 1-3 bones in my lower back.

I have a degenerative condition in my lower back.

Exclusion Criteria

I am allergic to opiates or zolpidem.

You have experienced confusion or disorientation while taking certain medications like opiates or zolpidem.

I am scheduled for a minimally invasive surgery to fuse vertebrae in my lower back.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive zolpidem or placebo two days preoperatively

2 days

Postoperative Treatment

Participants continue to receive zolpidem or placebo for five days postoperatively

5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Zolpidem Tartrate 10 mg

Trial Overview 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.

How Is the Trial Designed?

Group I: Zolpidem Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Zolpidem Tartrate 10 mg is already approved in United States, European Union for the following indications:

Approved in United States as Ambien for:

• Short-term treatment of insomnia

Approved in European Union as Zolpidem Tartrate for:

• Short-term treatment of insomnia in adults

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

Lemborexant showed significant improvements in sleep onset and maintenance compared to placebo and zolpidem in the SUNRISE 1 trial, indicating its efficacy as a treatment for insomnia.

In terms of cost-effectiveness, lemborexant was found to be a dominant option over suvorexant and zolpidem-IR, providing better quality-adjusted life years (QALYs) while also being more cost-effective compared to untreated insomnia in a Japanese healthcare context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness analysis of lemborexant for treating insomnia in Japan: a model-based projection, incorporating the risk of falls, motor vehicle collisions, and workplace accidents. Ikeda, S., Azuma, MK., Fujimoto, K., et al.[2022]

In a review of 12 pediatric cases of zolpidem exposure, symptoms appeared rapidly, typically within 10 to 60 minutes, indicating a quick onset of central nervous system effects in children.

For unintentional ingestions of zolpidem (5-30 mg), symptoms were generally minor and resolved within a few hours, while intentional overdoses (12.5-150 mg) led to more significant symptoms lasting longer, suggesting that supportive care and observation are key in managing these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zolpidem (Ambien): a pediatric case series. Kurta, DL., Myers, LB., Krenzelok, EP.[2019]

Zolpidem tartrate is an effective hypnotic agent that significantly decreases sleep latency and increases total sleep time without altering sleep architecture, making it a suitable alternative to traditional benzodiazepines.

It has a rapid absorption rate and a bioavailability of 67%, with an optimal dose of 10 mg for adults and 5 mg for elderly patients, while also showing fewer side effects like tolerance and withdrawal compared to benzodiazepines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zolpidem: a nonbenzodiazepine hypnotic for treatment of insomnia. Hoehns, JD., Perry, PJ.[2018]

A study involving 240 patients undergoing knee arthroplasty found that combining psycho-behavioral interventions with a lower dose of the non-benzodiazepine zolpidem significantly improved perioperative sleep quality compared to drug intervention alone.

The combination approach not only reduced the required dosage of zolpidem but also alleviated anxiety and enhanced patient satisfaction and overall quality of life during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled study of a psycho-behavioral intervention combined with a non-benzodiazepine to improve perioperative sleep quality in patients undergoing knee arthroplasty. Jing, W., Chunlin, Z., Xue, Y., et al.[2023]

A case study reported a fatal overdose of zolpidem (Ambien) in a 68-year-old woman who ingested at least 30 tablets, totaling 300 mg, highlighting the potential dangers of excessive use of this medication.

Toxicological analysis revealed high blood concentrations of zolpidem and other sedatives, indicating that combining zolpidem with other central nervous system depressants can increase the risk of severe adverse effects, including death.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute overdose of zolpidem. Winek, CL., Wahba, WW., Janssen, JK., et al.[2019]

Zolpidem, particularly at a 20 mg dose, effectively provided sedation before minor gynaecological surgery, but it also caused anterograde amnesia, which means patients had difficulty forming new memories after taking the medication.

While zolpidem did not significantly affect the course of anesthesia, it delayed postoperative recovery, especially with the 20 mg dose, indicating that while it can be useful for sedation, it may prolong the time it takes for patients to regain full psychomotor function after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a new hypnotic imidazo-pyridine (zolpidem) as oral premedication. Cashman, JN., Power, SJ., Jones, RM.[2019]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05746143/the-effect-of-zolpidem-on-outcomes-following-lumbar-spine-fusion

The Effect of Zolpidem on Outcomes Following Lumbar ... The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes ...

2. clinicaltrial.be clinicaltrial.be/en/details/259672?per_page=20&only_recruiting=0&only_eligible=0

The Effect of Zolpidem on Outcomes Following Lumbar ... Patients who are undergoing one- to three-level spinal fusion for degenerative lumbar disease will be recruited. They will be randomized to ...

3. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05746143?keyword=%22Spondylosis%22

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

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9536417/

The Pain Control Efficacy of Zolpidem versus Melatonin after ... An evaluation of the improvement of sleep quality after arthroplasty treated with zolpidem proved that 10 mg zolpidem can effectively improve sleep quality, ...

5. semanticscholar.org semanticscholar.org/paper/Enhanced-Recovery-after-Lumbar-Spine-Fusion.-Soffin-Beckman/fda79515fe18486d73def5cc26241a844de9d409

[PDF] Enhanced Recovery after Lumbar Spine Fusion. Impact of ultrasound-guided erector spinae plane block on outcomes after lumbar spinal fusion: a retrospective propensity score matched study of 242 patients.

6. clinconnect.io clinconnect.io/trials/NCT05746143

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

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7472584/

Zolpidem reduces pain intensity postoperatively: a systematic ... The current results should be interpreted with caution due to lack of data on safety, a small number of trials included in the pooled ...