Solriamfetol Titration and AdministRaTion (START) in Patients with Obstructive Sleep Apnea: A Retrospective Chart Review and Hypothetical Patient Scenario.

INTRODUCTION

Solriamfetol (Sunosi™), a dopamine/norepinephrine reuptake inhibitor, is approved (USA and EU) to treat excessive daytime sleepiness (EDS) in adults with obstructive sleep apnea (OSA) (37.5-150 mg/day). Real-world research on solriamfetol initiation is limited. The objective of this study was to describe dosing and titration strategies used when initiating solriamfetol and to assess whether and how patient factors affected these strategies.

METHODS

This descriptive study, featuring a quantitative retrospective patient chart review and hypothetical patient scenario, enrolled US-based physicians prescribing solriamfetol for EDS associated with OSA and/or narcolepsy. Initiation of solriamfetol was classified as: (1) de novo (EDS medication-naive); (2) transition (switched/switching from existing EDS medication[s] to solriamfetol), or (3) add-on (adding solriamfetol to current EDS medication[s]). Study fielding occurred 3-19 June 2020. Data were summarized descriptively.

RESULTS

Twenty-six physicians participated in the study, of whom 24 provided data from 50 patients with OSA (mean ± standard deviation [SD] age, 51.9 ± 9.1 years; 62% male). Mean apnea-hypopnea index at diagnosis indicated that most patients had severe OSA and 92% were adherent to positive airway pressure therapy. EDS was primarily moderate (56%) or severe (36%). Solriamfetol initiation was de novo for 44% of patients, transition for 52%, and add-on for 4%. Efficacy (including the need for better efficacy) was the primary reason for the initiation of solriamfetol as de novo (82%), transition (58%), and add-on (100%) therapy. Starting doses were predominantly 37.5 mg/day (48%) or 75 mg/day (48%); stable doses were typically 75 mg/day (56%) or 150 mg/day (40%). Most patients (64%) adjusted dosages once, reaching stable doses over a median (range) of 14 (1-74) days. Physicians considered EDS severity (32% of patients) when titrating, but more commonly no specific patient factors caused them to alter their titration (44% of patients). Physicians abruptly discontinued wake-promoting agents (WPAs; 17/18, 94%) and stimulants (6/9, 67%) for transitioning patients. The hypothetical patient scenario showed that physicians discontinuing prior WPAs commonly considered the current dose (23%) and potential adverse events (15%). Most patients (96%) were stable on solriamfetol at data collection.

CONCLUSIONS

In a real-world study, most physicians initiated solriamfetol at 37.5 or 75 mg/day and titrated to 75 or 150 mg/day for patients with EDS associated with OSA, adjusted dosages once, and abruptly discontinued prior WPAs. At data collection, most patients remained on solriamfetol.