Suvorexant Efficacy on Post-Operative Sleep Disturbance Evaluated in Double-Blind Randomized Trial

Post-operative sleep disturbance is a common and significant issue following surgery, negatively impacting patient recovery, pain management, and overall well-being. Current approaches often rely on non-specific sedatives, which can carry risks of daytime somnolence, cognitive impairment, and other adverse effects, without necessarily promoting restorative sleep. Suvorexant, a selective dual orexin receptor antagonist (DORA), offers a targeted mechanism by blocking the wakefulness-promoting effects of orexin neuropeptides. This mechanism aims to facilitate more natural sleep by reducing arousal, rather than inducing broad central nervous system depression. This Phase IV clinical trial aims to rigorously assess the efficacy and safety of Suvorexant specifically for managing sleep disturbances in the critical post-operative period.

This multi-site, parallel-group, double-blind, randomized, placebo-controlled Phase IV clinical trial enrolled 92 subjects undergoing elective orthopedic, abdominal, urologic, gynecologic, or spine surgery. The experimental arm (n=46) received 20 mg Suvorexant (flexible dose, which could be decreased to 10 mg if not well tolerated, e.g., due to daytime sleepiness). Dosing began on the first in-hospital night ("day 0") and continued throughout their hospital stay. The control arm (n=46) received placebo and standard treatment as usual. Blinding was maintained by administering two tablets to each arm (either two 10 mg tablets or one 10 mg tablet and a placebo).

This abstract describes the design and methodology of a clinical trial protocol and does not present any efficacy or safety results. The study aims to evaluate the effect of Suvorexant on post-operative sleep disturbance. Therefore, specific numerical findings, statistical analyses, or conclusions regarding the intervention's impact are not available in this protocol description. The primary outcome measure, while not explicitly stated, is implied to be related to post-operative sleep quality or disturbance. No data on sleep latency, sleep efficiency, wake after sleep onset, or adverse events are reported here.