SURWEY Study of Solriamfetol: Initiation, Titration, Safety, Efficacy, and Follow-up Experience for Patients with OSA in Germany
Yaroslav Winter1, Geert Mayer2, Heike Benes3, Lothar Burghaus4, Irnesha Abeynayake5, Samantha Floam5, Hannah Kwak6, Gregory Parks5, Ulf Kallweit7
11. Johannes Gutenberg-University, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Mainz, Germany, 2Philipps-Universität Marburg, 35. Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Schwerin, Germany, Heilig Geist-Hospital, 4Department of Neurology, Cologne, Germany, 5Axsome Therapeutics, 6Axsome Therapeutics (Former), 7University Witten/Herdecke, Center for Biomedical Education and Researchand Professorship for Narcolepsy and Hypersomnolence Research, Witten, Germany
Objective:
To characterize real-world dosing/titration strategies among German physicians initiating solriamfetol and patient outcomes following initiation.
Background:
Excessive daytime sleepiness (EDS) is a symptom of obstructive sleep apnea (OSA) that can persist despite efficacious suppression of apnea via primary airway therapy (PAT) and can be managed with wake-promoting agents, including solriamfetol, an approved treatment for EDS associated with OSA.
Design/Methods:
SURWEY was a retrospective chart review conducted by German physicians. German patients (n=83) diagnosed with EDS due to OSA, had reached a stable solriamfetol dose, and had completed ≥6 weeks of treatment were included. Patients were classified based on solriamfetol initiation strategy: 1) changeover (switched from existing EDS medication[s]), 2) add-on (added to current EDS medication[s]), or 3) new-to-therapy (no current EDS medication). Efficacy measures included the Epworth Sleepiness Scale (ESS) and patient- and physician-reported perceptions of improvement.
Results:
All patients (mean age=49 years; 65% male) used PAT. The most common initiation type was new-to-therapy (n=62), followed by add-on (n=12), and changeover (n=9). The most common starting doses of solriamfetol were 37.5 (n=57;69%) and 75 (n=23;28%) mg/day. Solriamfetol was titrated in 53 patients (64%); often within 7 days. Mean±SD ESS score was 16.0±3.2 (n=83) at initiation and 10.7±3.9 at follow-up (n=83; mean ESS decrease= 5.4±3.6). Across subgroups, mean ESS scores ranged from 15.9–16.6 (initiation) and 10.4-12.2 (follow-up), with mean decreases from 5.3–5.7 points. Improvement rates in EDS after solriamfetol initiation were patient-reported, 90%; physician-reported, 89%. Most patients reported solriamfetol effects lasted ≥6 hours (74%) without altering night-time sleep quality (91%). Common adverse effects were headache, insomnia, and irritability.
Conclusions:
In this real-world data from a cohort of German patients with OSA, solriamfetol was typically initiated at 37.5 mg/day and titration was common. ESS improvements were clinically meaningful, and most patients and physicians perceived improvement in EDS. No new safety signals were reported.