Solriamfetol Shows Therapeutic Benefits on Neuropsychological Outcomes in Excessive Daytime Sleepiness

Newly reported findings from the SURWEY study, a real-world, retrospective, observational trial, showed that treatment with solriamfetol (Sunosi; Axsome Therapeutics) led to improvements in a number of neuropsychological outcomes among patients with obstructive sleep apnea (OSA) and excessive daytime sleepiness (EDS). In the study, solriamfetol still reduced EDS, although there was no link between changes in OSA-associated cognitive impairment and EDS.¹

Presented at the 2025 SLEEP Annual Meeting, held June 8-11 in Seattle, Washington, the study featured 46 patients who were tested on number of neuropsychological outcomes prior to and 3 months after solriamfetol initiation. The assessments included the Test of Attentional Performance (TAP) subtest alertness, the Regensburger Word Fluency Test, the Wechsler Memory Scale subtest visual reproduction, Wechsler Adult Intelligence Scale (WAIS-IV) subtest coding and British Columbia Cognitive Complaints Inventory (BC-CCI).

In the study, data were analyzed using repeated measures ANOVA, and the relationship between changes in EDS and cognition was assessed through regression analysis. After 3 months of treatment with solriamfetol, participants experienced a 11.4% mean improvement in TAP scores, with statistically significant values (P <.01) observed for those with a warning signal (237.7 [±21.4]) and those without (239.5 [±21.3]).

Led by Yaroslav Winter, MD, MSc, head of Mainz Comprehensive Epilepsy and Sleep Medicine Center, Johannes Gutenberg University, solriamfetol-treated patients also showed a 40.8% (5.1 [±3.1]; P <.01) mean improvement in BC-CCI and a 30.6% (9.3 [±1.8]; P <.01) mean improvement in WAIS-IV across the 3-month period. Notably, patients also saw enhancements in Epworth Sleepiness Scale, demonstrated by score changes of 4.7 (±2.7; P <.01).

Coming into the study, participants demonstrated impaired alertness on the TAP (mean: 268.2 [±21.8] ms with warning signal; mean: 270.2 [±21.9] ms without), impaired cognitive function on the BC-CCI (8.2 [±2.2]), and reduced psychomotor and visual processing speed on the WAIS-IV coding subtest (7.1 [±1.5]). In the study, word fluency and memory were not impaired at baseline, or after solriamfetol initiation. Furthermore, there was no association between improvements seen in cognitive function and change in EDS (r = 0.16; P = .3).

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Solriamfetol, a dual dopamine and norepinephrine reuptake inhibitor, was approved by the FDA in March 2019 for the treatment of EDS associated with narcolepsy as well as for EDS in OSA as an adjunct to primary airway therapies. The once-daily medication has a half-life around 7 hours, is considered a schedule IV controlled substance, and comes with a caution for patients with cardiovascular disease or hypertension.

Data from SURWEY was previously published in Sleep Medicine in 2023, with results showing that solriamfetol titration is common, leading to improvements in EDS. In the real-world study, the most common starting doses overall were 75 mg/day (69%) or 150 mg/day (20%), with most of the remaining patients initiated at 37.5 mg. Almost half of the 70-patient cohort (43%) had their treatment titrated, with 90% completing titration as prescribed.²

In the study, patients were classified as either changeover (n = 43; 61%), add-on (n = 19; 27%), or new-to-therapy (n = 8; 11%) subgroups, based on existing EDS treatment. The mean age of the cohort was 36.9 (±13.9) years and mean body mass index was 26.7 (standard deviation [SD]. 5.2) kg/m. From initiation to follow-up, patients’ mean ESS score improved from 17.6 to 13.6. ESS scores improved regardless of initiation strategy, with mean decreases of 4.1 (SD, 2.9), 3.7 (SD, 2.6), and 6.1 (SD, 3.0) points from solriamfetol initiation to follow-up in the changeover, add-on, and new-to-therapy subgroups, respectively. Overall, 91% of patients reported slight or strong improvements in their EDS after initiating solriamfetol, with results similar across subgroups.

Solriamfetol previous demonstrated positive effects on cognition in patients with EDS through the placebo-controlled SHARP trial (NCT04789174). In the study, patients received solriamfetol 75 mg for 3 days followed by 150 mg/day for 2 weeks, and placebo for 2 weeks, with treatment periods separated by a 1-week washout. At the conclusion of the analysis, solriamfetol-treated individuals showed improved performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) relative to placebo (6.49 vs 4.75; P = .0009), with an effect size (Cohen’s d) of 0.36.³

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REFERENCES
1. Winter Y, Eglit GML, Floam S, Kallweit U. Effects of solriamfetol on neuropsychological outcomes in patients with obstructive sleep apnea in the real-world SURWEY study. Presented at: 2025 SLEEP Annual Meeting; June 8-11; Seattle, Washington. ABSTRACT 0784
2. Winter Y, Mayer G, Kotterba S. Solriamfetol real world experience study (SURWEY): initiation, titration, safety, effectiveness, and experience during follow-up for patients with narcolepsy from Germany. Sleep Med. 2023;103:138-143. doi:10.1016/j.sleep.2023.01.022.
3. Van Dongen H, Leary E, Drake C, et al. Solriamfetol demonstrates durable cognitive improvement in adults with obstructive sleep apnea and excessive daytime sleepiness. Presented at: 2023 SLEEP Annual Meeting; June 3-7; Indianapolis, Indiana. Abstract 0559