Abstract Details

Title Solriamfetol Real World Experience Study: Initiation, Titration, Safety, Effectiveness, and Experience During Follow-Up for Patients with Narcolepsy from Germany

Topic Sleep

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 11-006

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.

Authors/Disclosures
Gregory S. Parks, PhD (Axsome Therapeutics) PRESENTER	Dr. Parks has received personal compensation for serving as an employee of Axsome Therapeutics. Dr. Parks has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Parks has stock in Axsome Therapeutics. Dr. Parks has stock in Jazz Pharmaceuticals.
Yaroslav Winter	Prof. Winter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Angelini Pharma. Prof. Winter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bioprojet. Prof. Winter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Prof. Winter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia Pharmaceuticals. Prof. Winter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for JAZZ Pharmaceuticals. Prof. Winter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LivaNova. Prof. Winter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Pharma. Prof. Winter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Presisis.
Geert K. Mayer, MD, PhD (Philipps-Universität Marburg)	Dr. Mayer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Janssen, Idorsia, NLS Pharma. Dr. Mayer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia, Takeda. Dr. Mayer has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Idorsia.
Sylvia Kotterba, MD (Neurologische Klinik)	Dr. Kotterba has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Jazz. Dr. Kotterba has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bioprojet. Dr. Kotterba has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer. Dr. Kotterba has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for biogen.
Heike Benes	No disclosure on file
Lothar Burghaus	No disclosure on file
	No disclosure on file
Daniela Girfoglio	Daniela Girfoglio has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Daniela Girfoglio has stock in Jazz Pharmaceuticals.
	No disclosure on file
Ulf Kallweit	Ulf Kallweit has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Takeda. Ulf Kallweit has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bioprojet. Ulf Kallweit has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Ulf Kallweit has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bioprojet. Ulf Kallweit has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bioprojet. Ulf Kallweit has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pharmanovia. Ulf Kallweit has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier.

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