Solriamfetol Treatment of Excessive Daytime Sleepiness in Participants With Narcolepsy or Obstructive Sleep Apnea With a History of Depression

Background: Depression is commonly comorbid with narcolepsy and obstructive sleep apnea (OSA). Solriamfetol (SunosiTM), a dopamine/norepinephrine reuptake inhibitor, has been approved in the US to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy (75-150 mg) or OSA (37.5-150 mg). This post hoc analysis evaluated solriamfetol for EDS in participants with narcolepsy or OSA +/- history of depression (DHx+/DHx-).

Methods: In two 12-week trials, participants with narcolepsy or OSA were randomized to placebo or solriamfetol 37.5 (OSA only), 75, 150, or 300 mg/day. Week 12 changes from baseline in Maintenance of Wakefulness Test (MWT) sleep latency (minutes) and Epworth Sleepiness Scale (ESS) score for DHx+/DHx- subgroups were summarized.

Results: 27.5% (65/236) of participants with narcolepsy and 23.4% (111/474) with OSA were DHx+. On MWT, least squares (LS) mean (95% CI) difference from placebo for solriamfetol (combined doses) in narcolepsy was 5.4 (-0.2, 11.1) for DHx+ and 7.0 (3.3, 10.7) for DHx-, and in OSA was 7.7 (3.2, 12.3) for DHx+ and 10.7 (8.0, 13.3) for DHx-. For ESS, LS mean (95% CI) difference from placebo in narcolepsy was -3.8 (-6.3, -1.2) for DHx+ and -3.5 (-5.3, -1.6) for DHx-, and in OSA was -3.5 (-5.4, -1.6) for DHx+ and -3.7 (-4.9, -2.5) for DHx-. Common adverse events with solriamfetol—headache, decreased appetite, nausea, and anxiety—were consistent in DHx+/DHx- subgroups.

Conclusions: Solriamfetol was effective in treating EDS in narcolepsy or OSA regardless of depression history. Safety and tolerability were similar in both subgroups.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.