0561 Solriamfetol Real World Experience Study: Safety, Efficacy, and Follow-Up for Patients with Obstructive Sleep Apnea in Germany

Abstract Introduction Excessive daytime sleepiness (EDS) is a symptom of Obstructive Sleep Apnea (OSA) that can persist despite primary airway therapy and can be managed with wake-promoting agents. Solriamfetol (Sunosi®) is a wake-promoting agent approved to treat EDS associated with OSA (37.5–150 mg/day). This real-world study characterizes dosing/titration strategies among European physicians initiating solriamfetol and patient outcomes following initiation. Methods This is an ongoing retrospective chart review conducted by physicians in Germany and France. Data are reported from 52 German patients with OSA. Eligible patients (≥18 years old, diagnosed with EDS due to OSA, reached a stable solriamfetol dose, and completed ≥6 weeks of treatment) were classified into 1 of 3 groups based on solriamfetol initiation strategy: changeover (switched/switching from existing EDS medication[s]), add-on (added/adding to current EDS medication[s]), or new-to-therapy (no current/previous EDS medication). Results Patients’ mean±SD age was 50.0±13.1 years; 65% were male. All patients used primary airway therapy. Obesity was the most common comorbidity (56%). New-to-therapy was the most common initiation strategy (n=39), then add-on (n=9), and changeover (n=4). The most common starting doses of solriamfetol were 37.5 (n=34; 65%) and 75 mg/day (n=17; 33%). Solriamfetol was titrated in 30 patients (58%); the majority were titrated within 7 days. Mean±SD Epworth Sleepiness Scale (ESS) score was 15.5±3.2 (n=52) at initiation and 10.7±3.7 at follow-up (n=48), with a mean decrease of 5.0± 3.2 points. Across subgroups, mean ESS scores at initiation and follow-up ranged from 15.2–16.8 and 10.3-11.6, with mean decreases from 4.5–6.5 points. Improvements in EDS after solriamfetol initiation were reported for most patients (patient-reported, 90%; physician-reported, 88%). Most patients reported the effects of Solriamfetol to last ≥6 hours (81%) with no change in their night-time sleep quality (86%). Common adverse effects were headache, insomnia, and irritability. Conclusion These real-world data describe the use of solriamfetol in a cohort of German patients with OSA. Solriamfetol was typically initiated at 37.5 mg/day; titration was common. ESS improvements were greater than the minimum clinically important difference (MCID) of 2-3, and most patients and physicians perceived improvement in EDS. Common adverse events were consistent with those previously reported for solriamfetol. Support (if any) Axsome Therapeutics and Jazz Pharmaceuticals