Long-term efficacy of solriamfetol (JZP-110) for excessive daytime sleepiness (EDS) in narcolepsy and obstructive sleep apnea (OSA)
Bibliographic record
Abstract
Objective: Long-term efficacy of solriamfetol, a selective dopamine/norepinephrine reuptake inhibitor, was evaluated for EDS in narcolepsy and OSA. Methods: Participants had completed a previous solriamfetol study. Design: 2-week titration followed by an open-label phase =50 weeks. After 6 months, a subgroup entered a 2-week, placebo-controlled, randomized withdrawal (RW) phase with change in Epworth Sleepiness Scale (ESS) score as the primary endpoint and Patient and Clinician Global Impression of Change (PGI-C and CGI-C) as secondary endpoints. Results: 643 participants (226 narcolepsy; 417 OSA) in safety population; 280 (141 placebo; 139 solriamfetol) in RW efficacy population. At RW end, least-squares mean change on ESS was 5.3 for placebo and 1.6 for solriamfetol (P<0.0001); greater percentages of participants on placebo worsened on PGI-C/CGI-C (both P<0.0001). Solriamfetol demonstrated sustained improvements in ESS scores and PGI-C/CGI-C up to 1 year. At week 40, 43.0% narcolepsy and 81.7% OSA participants had an ESS score =10 (normal range). Common adverse events (AEs; =5%) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 subjects (4.2%) had =1 serious AE. Conclusions: Solriamfetol demonstrated long-term maintenance of efficacy for EDS in narcolepsy and OSA. Safety was similar to prior solriamfetol studies. Support: 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) | 0.001 | 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 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".