Long-term efficacy of solriamfetol for excessive sleepiness in narcolepsy or obstructive sleep apnea

Abstract

Introduction: Solriamfetol (JZP-110), a selective dopamine and norepinephrine reuptake inhibitor, was effective in treating excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea (OSA) in phase 3 studies. Aims and Objectives: To evaluate long-term safety and efficacy of solriamfetol for EDS in narcolepsy and OSA. Methods: Participants who completed prior solriamfetol studies initiated open-label (OL) solriamfetol with a 2-wk titration followed by a maintenance phase of ≤50 wk. A 2-wk placebo-controlled randomized withdrawal (RW) phase began after 6 mo. Change in Epworth Sleepiness Scale (ESS) during RW was the primary endpoint. Patient and Clinician Global Impression of Change (PGI-C and CGI-C, respectively) were secondary endpoints. Results: The safety population comprised 643 participants (226 narcolepsy; 417 OSA); 280 participants (141 placebo; 139 solriamfetol) comprised the RW modified intent-to-treat population. At RW end, least squares mean change in ESS score for placebo vs solriamfetol was 5.3 vs 1.6 (P Conclusions: These results demonstrate long-term efficacy and safety of solriamfetol for EDS in narcolepsy or OSA.