0560 Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm

Abstract Introduction Solriamfetol (Sunosi®), a dopamine/norepinephrine reuptake inhibitor that has been shown to activate TAAR1, is approved (US and EU) treat excessive daytime sleepiness (EDS) in adults with narcolepsy (75-150mg/day) or obstructive sleep apnea (OSA) (37.5-150mg/day). Effect size, number needed (NNT) harm (NNH) are statistical representations of efficacy tolerability clinicians may find helpful guiding treatment decisions. This analysis characterized these parameters from two registrational studies. Methods We conducted post-hoc data phase 3 studies associated (TONES 2) OSA 3). size compared placebo, NNT, NNH were calculated based on previously published endpoints, analyses, adverse events. Results On the Maintenance Wakefulness Test, effect placebo (Cohen’s d) was 0.29, 0.82, 1.13 for 75mg, 150mg, 300mg doses solriamfetol TONES 2 0.46, 0.89, 1.08, 1.28 37.5mg, 3. Epworth Sleepiness Scale (ESS), d 0.47, 0.80, 1.02 2, 0.42, 0.37, 0.99, 1.04 NNT patients achieving an ESS ≤10 7, 5, 8, 6, 4, Patient Global Impression Change (PGIc), 3, 75mg,150mg, 16, 37.5, Similar found Clinician as PGIc. In both pooled across events occurring ≥5% greater than all >10, exception headache (NNH=6). Conclusion demonstrates favorable values EDS OSA. Support (if any) Axsome Therapeutics