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: 0

140 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the drug Zolpidem for spinal fusion recovery?

Zolpidem is known to help with sleep by reducing the time it takes to fall asleep and increasing overall sleep time, which might indirectly aid recovery by improving sleep quality. However, there is no direct evidence from the provided research that supports its effectiveness specifically for spinal fusion recovery. ^{1 2 3 4 5}

How does the drug Zolpidem differ from other treatments for spinal fusion recovery?

Zolpidem is unique because it is primarily a sleep aid that works by binding to specific receptors in the brain to promote sleep, which may help improve recovery by enhancing rest. Unlike other treatments for spinal fusion recovery, it does not directly target pain or inflammation but may aid recovery indirectly by improving sleep quality. ^{1 2 3 4 6}

Eligibility Criteria

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 am between 18 and 75 years old.

I have a degenerative condition in my lower back.

I am having surgery to fuse 1-3 bones 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Acute overdose of zolpidem. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Zolpidem: a nonbenzodiazepine hypnotic for treatment of insomnia. [2018]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Zolpidem (Ambien): a pediatric case series. [2019]

5. Switzerland 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Assessment of a new hypnotic imidazo-pyridine (zolpidem) as oral premedication. [2019]