Effects of Solriamfetol on Quality-of-Life Measures from a 12-Week Phase 3 Randomized Controlled Trial

Area of Science:

• Sleep Medicine
• Pharmacology

Background:

• Excessive daytime sleepiness (EDS) in obstructive sleep apnea (OSA) significantly impacts patient well-being and productivity.
• Current treatments for OSA and EDS may not fully address the burden of illness associated with impaired daily functioning.

Purpose of the Study:

• To evaluate the efficacy of solriamfetol, a dopamine/norepinephrine reuptake inhibitor, on daily functioning, health-related quality of life, and work productivity.
• To assess solriamfetol's effects as an additional outcome in a 12-week Phase 3 clinical trial for OSA patients with EDS.

Main Methods:

• A randomized, double-blind, placebo-controlled Phase 3 trial involving 476 participants with OSA and EDS.
• Participants received solriamfetol (37.5, 75, 150, or 300 mg) or placebo, with outcomes assessed using validated questionnaires for functioning, quality of life, and work productivity.
• Statistical analysis employed a mixed-effects model with repeated measures to compare treatment groups against placebo.

Main Results:

• Solriamfetol at 150 mg and 300 mg demonstrated statistically significant improvements in daily functioning (Functional Outcomes of Sleep Questionnaire) compared to placebo.
• Significant reductions in overall work and activity impairment were observed with solriamfetol (150 and 300 mg).
• Improvements in both physical and mental component summaries of health-related quality of life (SF-36v2) were noted, particularly with the 150 mg dose for the mental component.

Conclusions:

• Solriamfetol effectively improves daily functioning, health-related quality of life, and work productivity in individuals with obstructive sleep apnea and excessive daytime sleepiness.
• The safety profile of solriamfetol in this trial was consistent with previously reported findings, with common adverse events including headache, nausea, decreased appetite, and anxiety.