Long-term efficacy of solriamfetol (JZP-110) for excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea (OSA)

Abstract

Objective: Long-term efficacy of solriamfetol, a selective dopamine/norepinephrine reuptake inhibitor, was evaluated for EDS in narcolepsy and OSA. Methods: Participants had completed a previous solriamfetol study. Design: 2-week titration followed by an open-label phase =50 weeks. After 6 months, a subgroup entered a 2-week, placebo-controlled, randomized withdrawal (RW) phase with change in Epworth Sleepiness Scale (ESS) score as the primary endpoint and Patient and Clinician Global Impression of Change (PGI-C and CGI-C) as secondary endpoints. Results: 643 participants (226 narcolepsy; 417 OSA) in safety population; 280 (141 placebo; 139 solriamfetol) in RW efficacy population. At RW end, least-squares mean change on ESS was 5.3 for placebo and 1.6 for solriamfetol (P Conclusions: Solriamfetol demonstrated long-term maintenance of efficacy for EDS in narcolepsy and OSA. Safety was similar to prior solriamfetol studies. Support: Jazz Pharmaceuticals.