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EFFECT OF ZOLPIDEM ON SLEEP QUALITY AND OPIOID CONSUMPTION FOLLOWING PRIMARY TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
Sponsor: Sanatorio Allende
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2025-08-05
Completion Date
2026-06-09
Last Updated
2026-09-03
Healthy Volunteers
No
Interventions
Zolpidem 10 mg tablets
Zolpidem 10 mg was administered orally once nightly for 14 consecutive nights following total knee arthroplasty.
Avocado-soybean unsaponifiables 300 mg
Avocado-soybean unsaponifiables (Prontal) 300 mg were administered orally once nightly for 14 consecutive nights following total knee arthroplasty.
Locations (1)
Sanatorio Allende
Córdoba, Córdoba Province, Argentina