Effects of Solriamfetol on Cognition in Obstructive Sleep Apnea With Excessive Daytime Sleepiness and Impaired Cognition in the SHARP Clinical Trial
Introduction: This analysis evaluated the effect of solriamfetol (Sunosi®), approved to treat excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA; 37.5–150 mg/day), on subjective cognitive function by examining overall scores and individual items of the British Columbia-Cognitive Complaints Inventory (BC-CCI).
Methods: SHARP was a randomized, double-blind, placebo-controlled, crossover trial in participants with impaired cognition associated with OSA and EDS. Participants received solriamfetol (75 mg for 3 days, then 150 mg/day), and placebo, each for 2 weeks, with a 1-week washout. BC-CCI items included forgetfulness/memory problems, slow thinking speed, trouble expressing thoughts, trouble finding the right word, poor concentration, trouble figuring things out, and vocational, family/friends, and social/recreational functioning. Changes from baseline were assessed using mixed models with repeated measures.
Results: SHARP enrolled 59 participants (mean±SD age 52.2±10.7y; 36% female). Baseline overall BC-CCI scores were 11.4±2.5; scores were comparable between solriamfetol/placebo (n=30; mean=11.4) and placebo/solriamfetol (n=29; mean=11.4) sequences. Overall BC-CCI scores improved with solriamfetol versus placebo (P=0.002; Cohen’s d=0.45). Baseline individual BC-CCI items scores were generally similar between sequences. Solriamfetol led to greater improvements compared with placebo in poor concentration (P=0.007; d=0.37), slow thinking speed (P=0.009; d=0.36), trouble finding the right word (P=0.042; d=0.28), trouble figuring things out (P=0.030; d=0.30), and forgetfulness/memory problems (P=0.013; d=0.34). No significant differences were found for functional items.
Conclusion: Consistent with previously observed improvement on objective cognition, solriamfetol led to significant subjective improvements overall, and particularly in domains related to memory, executive functioning, and processing speed.
