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

• Published in: Sleep medicine 2022-12, Vol.100, p.165-173
• Main Authors: Malhotra, Atul, Strollo, Patrick J., Pepin, Jean-Louis, Schweitzer, Paula, Lammers, Gert Jan, Hedner, Jan, Redline, Susan, Chen, Dan, Chandler, Patricia, Bujanover, Shay, Strohl, Kingman
• Format: Article
• Language: English
• Subjects: adults; Body Weight; cpap; duration; Humans; JZP-110; Life Sciences; Lung; metaanalysis; Narcolepsy - complications; Narcolepsy - drug therapy; Neurosciences; Neurosciences & Neurology; Neurovetenskaper; Obesity; oral jzp-110 adx-n05; orexin; positive airway pressure; Sleep apnea; Sleep Apnea, Obstructive - complications; Sleep Apnea, Obstructive - drug therapy; Solriamfetol; Sunosi; wakefulness; Weight Loss
• ISSN: 1389-9457; 1878-5506
• DOI: 10.1016/j.sleep.2022.08.005

This 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. In 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. After 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. Solriamfetol treatment was associated with decreases in body weight in a dose-related manner. [Display omitted] •Overweight and obesity are prevalent in obstructive sleep apnea and narcolepsy.•Solriamfetol commonly is associated with decreased appetite.•After ≤52 weeks solriamfetol, overall median weight change was −1.76% from baseline.•A quarter of solriamfetol-treated participants had weight loss ≥5% of baseline.•Solriamfetol treatment was associated with dose-related decreases in weight.