Solriamfetol real world experience study (SURWEY): Initiation, titration, safety, effectiveness, and experience during follow-up for patients with narcolepsy from Germany
- PMID: 36796288
- DOI: 10.1016/j.sleep.2023.01.022
Solriamfetol real world experience study (SURWEY): Initiation, titration, safety, effectiveness, and experience during follow-up for patients with narcolepsy from Germany
Abstract
Background: Excessive daytime sleepiness (EDS) is a core narcolepsy symptom, for which solriamfetol (Sunosi®) was recently approved in the European Union. SURWEY characterises real-world strategies used by physicians when initiating solriamfetol, and patient outcomes after follow-up.
Methods: SURWEY is an ongoing retrospective chart review conducted by physicians in Germany/France/Italy. Here, data are reported from 70 German patients with EDS and narcolepsy. Eligibility included age ≥18 years, reached a stable solriamfetol dose, and completed ≥6 weeks of treatment. Patients were classified (based on existing EDS treatment) into changeover, add-on, or new-to-therapy subgroups.
Results: Patients' mean ± SD age was 36.9 ± 13.9 years. Changeover from prior EDS medication was the most common initiation strategy. Initial solriamfetol dose was typically 75 mg/day (69%). In 30 patients (43%), solriamfetol was titrated; 27/30 (90%) completed titration as prescribed, most within 7 days. Mean ± SD Epworth Sleepiness Scale (ESS) score was 17.6 ± 3.1 at initiation (n = 61) and 13.6 ± 3.8 at follow-up (n = 51). Slight/strong improvements in EDS were perceived for >90% of patients (patient and physician report). Sixty-two percent reported an effect duration of 6 to <10 h; 72% reported no change in perceived nighttime sleep quality. Common adverse events included headache (9%), decreased appetite (6%), and insomnia (6%); no cardiovascular events were reported.
Conclusions: Most patients in this study were switched from a prior EDS medication to solriamfetol. Solriamfetol was typically initiated at 75 mg/day; titration was common. ESS scores improved after initiation, and most patients perceived improvement in EDS. Common adverse events were consistent with those reported in clinical trials.
Gov registration: N/A.
Keywords: Europe; Excessive daytime sleepiness; Germany; Narcolepsy; Solriamfetol.
Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.
Conflict of interest statement
Declaration of competing interest Y Winter has received honoraria for educational presentations and consultations from Arvelle Therapeutics, Angelini Pharma, Bayer AG, Bioprojet Pharma, Bristol Myers Squibb, Eisai, Eythpharm GmbH, GW Pharmaceuticals, Jazz Pharmaceuticals, LivaNova, Neuraxpharm, Novartis, and UCB Pharma not related to the current study. G Mayer is on the advisory board for Janssen Pharma in Germany and NLS Pharma in Basel, Switzerland. S Kotterba received honoraria for educational presentations and consultations from Bioprojet Pharma and Jazz Pharmaceuticals. H Benes and L Burghaus have nothing to disclose. A Koch, D Girfoglio, and M Setanoians are employees of Jazz Pharmaceuticals who, in the course of this employment, have received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. U Kallweit is on the advisory board at AOP Orphan Pharmaceuticals, Bioprojet Pharma, Jazz Pharmaceuticals, Harmony Biosciences, Takeda Pharma, and UCB Pharma. He is also a consultant to AOP Orphan Pharmaceuticals, Bioprojet Pharma, Jazz Pharmaceuticals, Harmony Biosciences, and Takeda Pharma, and has accepted grants/research support from Bioprojet Pharma, Jazz Pharmaceuticals, and Harmony Biosciences.
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