Frequently Asked Questions

Yes. In this 6-week double-blind pilot trial, solriamfetol was associated with significantly greater improvement in adult ADHD symptoms than placebo. Mean AISRS total score improved by 7.6 points with solriamfetol versus 2.1 points with placebo by week 6 (P = .0012; effect size = 1.09), and the between-group mean AISRS difference at week 6 was −4.3 points (95% CI, −7.7 to −1.0; P = .0106).

Separation from placebo emerged by week 3, when the difference in mean AISRS scores was −3.4 points (95% CI, −6.7 to −0.1; P = .0439), and remained significant through week 6.

Clinician-rated ADHD symptoms separated significantly from placebo by week 3. At week 3, the difference in mean AISRS scores was −3.4 points in favor of solriamfetol (95% CI, −6.7 to −0.1; P = .0439), and by week 6 the difference was −4.3 points (95% CI, −7.7 to −1.0; P = .0106).

The treatment signal was stronger for inattention. On the AISRS inattentive subscale, improvement favored solriamfetol over placebo by 4.0 points at week 6 (P = .001; effect size = 1.59). On the AISRS impulsive-hyperactive subscale, the treatment-placebo difference was 1.4 points (P = .024; effect size = 0.34).

Response rates were higher with solriamfetol than with placebo. Using the prespecified response definition of at least 25% improvement in AISRS total score plus a CGI rating of much improved or very much improved, 45% of participants on solriamfetol responded versus 6.9% on placebo (P = .0020).

By week 6, 52% of participants on solriamfetol achieved at least 25% AISRS improvement versus 17% on placebo (P = .0119), and 28% versus 3.4% achieved at least 50% improvement (P = .0253).

Yes, remission-level AISRS thresholds were reached more often with solriamfetol. By week 6, 59% of participants on solriamfetol had an AISRS total score of 18 or lower versus 21% on placebo (P = .0067). A stricter AISRS threshold of 12 or lower was reached by 24% on solriamfetol versus 3% on placebo (P = .0517).

Yes. Solriamfetol was associated with better global functioning and better self-reported executive function than placebo. Mean GAF scores improved significantly more in the treatment group, with a 4.8-point improvement versus 0.3 points with placebo (P = .0006).

On the BRIEF-A, 69% of participants on solriamfetol versus 34% on placebo had a 0.5-standard deviation improvement in the Global Executive Composite (P = .0173). Similar advantages were reported for the Metacognition Index (66% vs 34%, P = .0348), Shift subscale (69% vs 34%, P = .0173), and Initiate subscale (62% vs 31%, P = .0343).

Yes. Self-reported ADHD symptoms improved significantly more with solriamfetol than with placebo. MASRS total scores changed by −11.1 points with solriamfetol (95% CI, −14.6 to −7.7) versus −3.9 points with placebo (95% CI, −7.4 to −0.5; P = .0047; effect size = 1.23).

MASRS inattentive scores improved by −5.9 versus −1.7 points (P = .0022; effect size = 1.30), and MASRS hyperactivity scores improved by −5.2 versus −2.4 points (P = .0366; effect size = 0.55).

Solriamfetol improved daytime sleepiness but did not show a significant advantage over placebo for sleep quality. ESS scores improved significantly more in the treatment group, with a mean reduction of 2.4 points (P = .0056).

By contrast, there was no significant between-group difference in change in PSQI total or subscale scores from baseline to week 6. The study also found that improvement in ESS sleepiness ratings did not moderate AISRS improvement (P = .3735), suggesting that ADHD symptom improvement was not explained by wakefulness alone.

In this pilot study, solriamfetol was generally well tolerated, and no significant between-group differences were found in changes in heart rate or blood pressure. From baseline to week 6, heart rate changed by +3.7 bpm with solriamfetol versus +2.2 bpm with placebo (P = .5609), systolic blood pressure by +2.4 versus +1.5 mm Hg (P = .6474), and diastolic blood pressure by +1.1 versus +1.5 mm Hg (P = .8117).

There were 4 subjects on solriamfetol and 3 on placebo who met the study definition of clinically meaningful high blood pressure readings, and no subjects had abnormal heart rates above 100 bpm at 2 consecutive visits. Adverse events led to dose adjustment or interruption in 10 subjects on active treatment and 4 on placebo, and 1 participant on active solriamfetol discontinued at week 6 because of skin itching.

The adverse event categories occurring at least 10 percentage points more often with solriamfetol than placebo were decreased appetite, headache, gastrointestinal symptoms, insomnia, increased energy, cardiovascular symptoms, and neurologic symptoms. The most differentiating repeated adverse event pattern was decreased appetite, which occurred in 3 individuals on solriamfetol and none on placebo.

All adverse events were mild or moderate except for 1 syncope episode in a participant on placebo. The study did not find a statistically significant treatment effect on adverse event body-system categories, repeated adverse event categories, or moderate-or-worse adverse event categories.

This was a 6-week, randomized, double-blind, placebo-controlled pilot study conducted entirely by remote virtual visits in 60 adults with ADHD. Participants were 18 to younger than 65 years old, met DSM-5 criteria for ADHD, and had an AISRS score of at least 20.

Subjects were randomized to solriamfetol 75 mg or placebo, with dose optimization to 150 mg if tolerated. Weekly assessments included clinician-rated ADHD symptoms, global functioning, clinical global impressions, vital signs, and adverse events, with baseline and endpoint self-ratings for ADHD symptoms, executive function, sleep quality, and daytime sleepiness.

The main limitations were that this was a small pilot trial, nearly all actively treated participants increased to 150 mg, and the study used home blood pressure monitoring in an all-remote design. The authors also noted a low placebo response, which could have contributed to larger effect size estimates.

Additional limitations included baseline sex imbalance, the possibility that concomitant medications may have influenced adverse effects, and uncertainty about whether higher doses might have produced stronger effects for some participants. The authors concluded that replication is needed to confirm efficacy, clarify optimal dosing, and better compare solriamfetol with other ADHD treatments.