Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy

Abstract

ObjectivesThis analysis characterized changes in weight in participants with obstructive sleep apnea (OSA) or narcolepsy treated with solriamfetol (Sunosi™) 37.5 (OSA only), 75, 150, or 300 mg/d. MethodsIn two 12-week, randomized, placebo-controlled trials and one 1-year open-label extension study, changes in weight were evaluated from baseline to end of study (week 12 or week 40 of the open-label extension [after up to 52 weeks of solriamfetol treatment]) in participants with OSA or narcolepsy. ResultsAfter 12 weeks of solriamfetol treatment, median percent change in weight from baseline across all solriamfetol doses was −0.84%, compared with 0.54% for placebo, in participants with OSA; and −0.07%, compared with 3.08% for placebo, in participants with narcolepsy. After up to 52 weeks of solriamfetol treatment, overall median percent change in weight from baseline was −1.76%, which showed a dose-dependent pattern (75 mg, 0.57%; 150 mg, −1.2%; 300 mg, −2.5%). Results were similar in subgroups of participants with OSA or narcolepsy, with overall median percent changes in weight of −2.2% and −1.1%, respectively. After up to 52 weeks of solriamfetol treatment, the percentage of participants with weight loss ≥5% relative to baseline was 25.7% overall and increased in a dose-dependent manner (75 mg, 4.5%; 150 mg, 17.3%; 300 mg, 32.4%). Results were similar among subgroups of participants with OSA or narcolepsy, with 26.4% and 24.2% of participants experiencing weight loss ≥5%, respectively. No weight-related treatment-emergent adverse events were serious. ConclusionsSolriamfetol treatment was associated with decreases in body weight in a dose-related manner.