drugset / Trial / NCT07801742
EFFECT OF ZOLPIDEM ON SLEEP QUALITY AND OPIOID CONSUMPTION FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
RandomizedParallel-groupTriple-blindTreatment
Summary
This clinical trial evaluated whether zolpidem could improve sleep quality and postoperative recovery in patients undergoing total joint arthroplasty. Participants were randomly assigned to receive either zolpidem 10 mg or a placebo for 14 nights, beginning after hospital discharge. Neither the participants nor their physicians knew which treatment was assigned. The study assessed sleep quality and duration, postoperative pain, use of pain medications, functional recovery, satisfaction, and adverse events. The study hypothesis was that improving sleep with zolpidem would lead to better sleep and potentially improve pain control and recovery after surgery compared with placebo.
Timeline
- Start
- 2025-08-05
- Primary completion
- 2026-06-09
- Completion
- 2026-06-09
Publications
- Background O'Hagan ET, Hubscher M, Miller CB, Gordon CJ, Gustin S, Briggs N, McAuley JH. Zolpidem reduces pain intensity postoperatively: a systematic review and meta-analysis of the effect of hypnotic medicines on post-operative pain intensity. Syst Rev. 2020 Sep 3;9(1):206. doi: 10.1186/s13643-020-01458-8.
- Background Krenk L, Jennum P, Kehlet H. Postoperative sleep disturbances after zolpidem treatment in fast-track hip and knee replacement. J Clin Sleep Med. 2014 Mar 15;10(3):321-6. doi: 10.5664/jcsm.3540.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Avocado-soybean unsaponifiables | Unknown | 300 mg | Oral |
| Subject | Zolpidem | Small molecule | 10 mg | Oral |
Indications
No indication recorded.