Key Takeaways
Extended Takeaways
- Separation from placebo on clinician-rated ADHD symptoms emerged by week 3, with an AISRS mean difference of −3.4 (95% CI, −6.7 to −0.1; P = .0439), and reached −4.3 (95% CI, −7.7 to −1.0; P = .0106) by week 6.
- The signal was strongest for inattention: week 6 AISRS improvement favored solriamfetol by 4.0 points on the inattentive subscale (P = .001; effect size = 1.59) versus 1.4 points on the impulsive-hyperactive subscale (P = .024; effect size = 0.34).
- Remission-level symptom thresholds were more often reached with solriamfetol, with AISRS total score ≤ 18 in 59% versus 21% (P = .0067); the stricter threshold of 12 was met by 24% versus 3% (P = .0517).
- Functional and executive outcomes also improved, with GAF changing by −4.8 points; 95% CI, 3.1 to 6.6 vs −0.3 points; 95% CI, −1.4 to 2.1; P = .0006, and 69% versus 34% achieving a 0.5–standard deviation improvement on the BRIEF-A Global Executive Composite (P = .0173).
- Improved wakefulness does not appear to fully explain the ADHD benefit: ESS scores improved by −2.4 points (P = .0056), but change in sleepiness did not moderate AISRS improvement (P = .3735), and PSQI outcomes did not differ significantly between groups.