Solriamfetol Real World Experience Study: Initiation, Titration, Safety, Effectiveness, and Experience During Follow-Up for Patients with Narcolepsy from Germany
Yaroslav Winter1, Geert Mayer2, Sylvia Kotterba3, Heike Benes4, Lothar Burghaus5, Gregory Parks6, Andreas Koch7, Daniela Girfoglio7, Melinda Setanoians7, Ulf Kallweit8
1Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, 2Hephata Klinik and Philipps University, 3Klinikum Leer, 4Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, 5Neurology, Heilig Geist-Hospital, 6Axsome Therapeutics, 7Jazz Pharmaceuticals, 8Center for Biomedical Education and Research, University Witten/Herdecke
Objective:
This real-world study characterises dosing/titration strategies among European physicians initiating solriamfetol and patient outcomes following initiation.
Background:
Excessive daytime sleepiness (EDS) is a symptom of narcolepsy that may be managed with wake-promoting agents or sodium oxybate. Solriamfetol (Sunosi™) is a dopamine/norepinephrine reuptake inhibitor approved to treat EDS associated with narcolepsy (75–150 mg/day).
Design/Methods:
This is an ongoing retrospective chart review conducted by physicians in Germany, France, and Italy. Data are reported from 70 German patients with narcolepsy. Eligible patients (≥18 years old, diagnosed with EDS due to narcolepsy, reached a stable solriamfetol dose, and completed ≥6 weeks of treatment) were classified into 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 36.9±13.9 years. 56% were female. 57% experienced cataplexy. Anxiety/depression was the most frequently reported comorbidity (36%). Changeover was the most common initiation strategy (61%), followed by add-on (27%), then new-to-therapy (11%). The most common starting doses of solriamfetol were 75 (69%) and 150 mg/day (20%). Solriamfetol was titrated in 29 patients (41%), mostly within 7 days. Mean±SD Epworth Sleepiness Scale (ESS) score was 17.6±3.1 (n=61) at initiation and 13.6±3.8 at follow-up (n=51), with a mean decrease of 4.3±2.9 points. Improvements in EDS after solriamfetol initiation were reported for most patients (patient-reported, 91%; physician-reported, 94%). Most patients (72%) reported no change in perceived night-time sleep quality. Common adverse effects were headache, decreased appetite, and insomnia. No cardiovascular events were reported.
Conclusions:
These real-world data describe the use of solriamfetol in a cohort of German patients with narcolepsy. Solriamfetol was typically initiated at 75 mg/day; titration was common. ESS scores improved across subgroups; most patients and physicians perceived improvement in EDS. Common adverse events were consistent with those previously reported for solriamfetol.