1024 SURWEY: Treatment of Excessive Daytime Sleepiness with Solriamfetol: Initiation, Titration, and Outcomes

Abstract Introduction Solriamfetol (Sunosi®), a dopamine/norepinephrine reuptake inhibitor with agonistic properties at TAAR1 and 5HT1A receptors, is a wake-promoting agent approved to treat excessive daytime sleepiness (EDS) associated with narcolepsy (75–150 mg/day) or obstructive sleep apnea (OSA; 37.5–150 mg/day). Real world data on solriamfetol safety and efficacy remains limited. Here we review real-world survey results to evaluate dosing/titration strategies and outcomes on EDS in patients with OSA, narcolepsy, and the pooled (OSA + narcolepsy) population. Methods Data from a retrospective chart review (SURWEY) by German physicians who prescribed solriamfetol for EDS associated with narcolepsy or OSA were analyzed. Inclusion criteria have been previously reported. Initiation and titration strategies (new-to-therapy, changeover, add-on) and Epworth Sleepiness Scale (ESS) scores are reported for each diagnosis and the pooled population to examine EDS as a symptom independent of etiology. Results Differences in baseline age, sex, and body mass index were observed for OSA (n=83) and narcolepsy (n=71) patients. Most common initiation strategy was new-to-therapy (n=63/83; 74.7%) for OSA and changeover (n=44/71; 62.0%) for narcolepsy. Patients with a final dose ≥150 mg/day were n=16 (19.5%), n=31 (45.6%), and n=47 (26.1%) for OSA, narcolepsy, and pooled, respectively. At initiation, mean±SD ESS scores were similar: 16.0±3.2 (OSA), 17.6±3.1 (narcolepsy), 16.7±3.2 (pooled). Mean±SD change from baseline in ESS scores at final follow-up were –5.4±3.6 (OSA), –4.5±3.2 (narcolepsy), –5.0±3. 5 (pooled). In the pooled analysis, ESS scores improved by 5.5, 4.7, and 4.4 in new-to-therapy, changeover, and add-on groups, respectively. In the changeover group, ESS scores improved by 5.7, 4.7, 4.6, and 4.0 points in patients who switched to solriamfetol from modafinil (n=13), stimulants (n=3), pitolisant (n=16), or unknown medication (n=21), respectively, while patients who added solriamfetol to pitolisant (n=13) or modafinil (n=3) improved by 4.4 and 3.3 points, respectively. Common adverse effects were headache, insomnia, and decreased appetite. Conclusion These real-world data describe the use of solriamfetol in patients with EDS in OSA or narcolepsy. Titration strategies differed by primary etiology but changes in ESS scores were similar. Although sample size was limited, clinically meaningful improvements in ESS scores were observed with solriamfetol regardless of switch/add-on medication. Support (if any) Axsome Therapeutics, Jazz Pharmaceuticals, Pharmanovia