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Abstract

Introduction

Solriamfetol, a selective dopamine and norepinephrine reuptake inhibitor, demonstrated long-term (up to 52 weeks) efficacy in participants with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). These analyses evaluated long-term effects of solriamfetol on quality of life (QoL) measures.

Methods

Participants with narcolepsy or OSA who completed previous solriamfetol studies were eligible. This study included 2-week titration followed by a maintenance phase of up to 50 weeks (stable dose 75, 150, or 300 mg). QoL assessments included the Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and 36-Item Short Form Health Survey version 2 (SF-36v2). Mean (SD) change from baseline throughout the study was evaluated for the overall safety population and by subgroup (OSA or narcolepsy). No formal statistical testing was performed. Safety was assessed.

Results

There were 643 participants (417 OSA, 226 narcolepsy) in the safety population. Increases in mean FOSQ-10 total score from baseline [mean change (SD) of 3.7 (3.0)] were sustained for the duration of treatment with solriamfetol; magnitude of change was similar between narcolepsy and OSA. On WPAI:SHP, participants reported a minimum 25% reduction (improvement) from baseline for % activity impairment outside of work, % impairment while working (presenteeism), and % overall work impairment due to the problem; results were generally similar for each subgroup. For SF-36v2, both physical and mental component summary scores showed increases in the health state of participants from baseline [mean change (SD) of 3.1 (6.9) and 4.3 (8.4), respectively]; these improvements were maintained for the duration of the study. Common adverse events (≥5%) included headache, nausea, insomnia, nasopharyngitis, dry mouth, anxiety, decreased appetite, and upper-respiratory-tract infection, and were similar in narcolepsy and OSA; 27 participants (4.2%) had ≥1 serious adverse event.

Conclusion

Solriamfetol demonstrated sustained improvements in QoL measures for up to 52 weeks in participants with EDS associated with narcolepsy or OSA. Safety was similar to prior solriamfetol studies.

Support (If Any)

Jazz Pharmaceuticals

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© Sleep Research Society 2019. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail [email protected].
This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://dbpia.nl.go.kr/journals/pages/open_access/funder_policies/chorus/standard_publication_model)
Topic:
Issue Section:
B. Clinical Sleep Science and Practice > III. Hypersomnia
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