Solriamfetol for the treatment of excessive daytime sleepiness in participants with obstructive sleep apnea with different levels of adherence to primary OSA therapy: Subgroup analysis of a randomized clinical trial.

BACKGROUND

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA). The current study aims to evaluate effects of solriamfetol among participants with different adherence to primary OSA therapy using data from a randomized clinical trial conducted among Chinese participants.

METHODS

Participants were 1:1 randomized to placebo or solriamfetol (up to 150 mg/day) for 12 weeks (stratified by adherence to primary OSA therapy). The coprimary endpoints were change from baseline in mean sleep latency of maintenance of wakefulness test (MWT) and Epworth Sleepiness Scale (ESS) at week 12 in the full analysis set. Use of primary OSA therapy and safety were also evaluated.

RESULTS

At baseline, of all participants, around 50 % were adherent, 20 % were non-adherent and 30 % were not on primary OSA therapy, respectively. In all subgroups, solriamfetol treatment was associated with significant or numerical improvement in MWT sleep latency or ESS (LS mean difference vs. placebo, p < 0.05 except ESS in non-adherence to primary therapy subgroup). Use of primary OSA therapy was stable throughout the 12-week study. Solriamfetol was well tolerated and the most common TEAEs included metabolism and nutrition disorders, upper respiratory tract infection, dizziness, hypertension and elevated blood creatine phosphokinase.

CONCLUSION

In the subgroup analysis of a randomized clinical trial in Chinese OSA participants with EDS, solriamfetol was effective and well tolerated regardless of adherence to primary OSA therapy. No clinically meaningful impact of solriamfetol on the use of primary OSA therapy was found.