0601 Long-term Effects Of Solriamfetol On Quality Of Life In Participants With Excessive Daytime Sleepiness Associated With Narcolepsy Or Obstructive Sleep Apnea
Bibliographic record
Abstract
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. 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. 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. 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. Jazz Pharmaceuticals
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".