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

NCT07801742 ↗

Phase 4 Completed 54 enrolled Sanatorio Allende
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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Avocado-soybean unsaponifiables Unknown 300 mg Oral
Subject Zolpidem Small molecule 10 mg Oral

Indications

No indication recorded.