Sleep Medication Solriamfetol Effectively Treats ADHD, Study Finds

Credit: CHADD

A new study discovered that solriamfetol, a medication approved by the US Food and Drug Administration (FDA) to treat narcolepsy and sleep apnea, is a safe, effective treatment for adults with ADHD. ¹

While currently used to treat sleep issues, solriamfetol—a dopamine and norepinephrine reuptake inhibitor—shares sympathomimetic properties existing in agents that treat ADHD.

According to a previous study, 40% of adults with ADHD had “unresolved and clinically significant impairment in essential elements of executive behavior”—which is why a new drug like solriamfetol could help benefit people with ADHD.² For some people, the current ADHD medication might produce side effects or simply not work effectively. Because of this, the investigators wanted to see if solriamfetol could be a new, viable option.1

“To our knowledge, this report is the first on the effects of solriamfetol in adults with ADHD and the first remotely conducted clinical psychopharmacology trial in adults with ADHD,” investigators led by Craig Surman, MD, director of the clinical and research program in adult ADHD at Massachusetts General Hospital, wrote.

The randomized, double-blind, and 6-week dose optimization trial included adults with DSM-5 ADHD, aged >18 and <65 years old (n = 60). The participants were broken into 2 groups: solriamfetol treatment (n = 16) and placebo (n = 11). More women were exposed to solriamfetol. The study took place from August 2021 - January 2023.

The team’s primary outcome measure was the Adult ADHD Investigator Symptom Rating Scale (AISRS). Other measures used included Clinical Global Impressions Scale (CGI); vital signs; the Global Assessment of Functioning (GAF); the Behavior Rating Inventory of Executive Function-Adult Form (BRIEF-A); the Epworth Sleepiness Scale (ESS); the Pittsburgh Sleep Quality Index (PSQI); and a modified Adult ADHD Self-Report Scale (MASRS).

Participants started with 75 mg solriamfetol or placebo and rose dosages if there were no ill-effects. For these participants with no ill effects, they were switched to 2 capsules in the morning, but if they couldn’t handle the dosage, were returned to 1 capsule.

However, if a subject took 1 capsule but had nearly no ADHD symptoms, as measured by the CGI rating and the AISRS, they could remain on 1 capsule daily.

At each visit, the investigator reviewed several variables: change in blood pressure and heart rate, spontaneously reported adverse events, the amount of improvement on the AISRS rating scale, and CGI-Improvement scores.

Solriamfetol had a positive outcome on people with ADHD, with no significant effect on mean heart rate (+3.7 vs +2.2 bpm, P = .5609), systolic blood pressure (+2.4 vs +1.5 mm Hg, P = .6474), or diastolic blood pressure (+1.1 vs +1.5 mm Hg, P = .8117).

Compared to the placebo group, participants on solriamfetol had a higher percentage of adverse effects (by 10 points) in the categories of decreased appetite; headache; gastrointestinal; insomnia; increased energy; cardiovascular; and neurologic. They also had an improved—and thus reduced—AISRS score of >25% (45% vs 6.9%; P = .0020).

“Adverse effects that occurred at a higher rate in the treatment group than the placebo group were typical of FDA guidance for solriamfetol and for sympathomimetic agents used for ADHD, and we found no evidence of stronger cardiovascular effects in the treatment group than in the placebo group,” the team wrote. “This combination of efficacy and tolerability, as well as the Schedule IV status of solriamfetol, positions it as potentially preferable for subsets of patients.”

Overall, mean improvement in AISRS ratings was significantly greater for individuals taking solriamfetol, with a mean difference of −3.4 (95% CI, −6.7 to −0.1; P = .0439) by week 3. By week 6, the mean difference was −4.3 (95% CI, −7.7 to −1.0; P = .0106). The mean total improvement in AISRS score by week 6 was -7.6 while -2.1 for individuals on placebo (P = .0012).

“Because we found that 48% of individuals on solriamfetol had this much improvement in AISRS ratings, we believe that future research is needed to clarify how MCID for the AISRS may be best estimated in studies like the pilot one we present,” the investigators wrote.

The team observed similar results for AISRS subscales. For example, for the AISRS attentive subscale, the mean improvement was greater for treatment than for placebo by 4 points (P =.001). Meanwhile for the impulsive-hyperactive subscale, the treatment group had greater improvement by 1.4 points (P = .024).

By the sixth week, more individuals on solriamfetol (24%) than placebo (3%) met remission AISRS total score definitions of 12 (P = .0517).

As for the CGI ratings, 45% of subjects in treatment group greatly improved while only 6% did in the placebo group.

There was not a significance difference in the PSQI scores, but the ESS mean sleepiness scores improved significantly more for the treatment group (-2.4 points; P = .0056).

The investigators explained that sleep disorders are often comorbid with ADHD and treatments that improve sleepiness can also help daytime function.

“While prior research has evaluated the impact of stimulant treatment on sleep quality in adults with ADHD, showing that there is no clear effect over that of placebo, this study was, to our knowledge, the first clinical trial of an ADHD treatment to evaluate change in a validated measure of sleepiness,” the investigators wrote. “We found that improvement in wakefulness did not moderate change in ADHD symptom burden with solriamfetol, suggesting that the robust improvement in ADHD symptoms was not due to wakefulness alone.”

References

1. ^{Surman CBH, Walsh DM, Horick N, DiSalvo M, Vater CH, Kaufman D. Solriamfetol for Attention-Deficit/Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study. J Clin Psychiatry. 2023;84(6):23m14934. Published 2023 Oct 9. doi:10.4088/JCP.23m14934}
2. ^{Brown TE, Landgraf JM. Improvements in executive function correlate with enhanced performance and functioning and health-related quality of life: evidence from 2 large, double-blind, randomized, placebo-controlled trials in ADHD. Postgrad Med. 2010;122(5):42–51. PubMed CrosRef}