Young et al. (2025)
  • Authors: Joel L. Young, Richard N. Powell, Anna Powell, Lisa L. M. Welling, Lauren Granata, Jaime Saal.
  • Institutes: Rochester Center for Behavioral Medicine, Rochester Hills, MI, USA; MedaData, LLC, Rochester Hills, MI, USA; School of Medicine - Wayne State University, Detroit, MI, USA; Department of Psychology, Oakland University, Rochester, MI, USA.
  • Publisher: Journal of Psychopharmacology
  • Link: DOI

Summary

This study provides preliminary evidence that solriamfetol, a drug already approved for conditions like narcolepsy, may also be effective in reducing the severity of fatigue and improving certain cognitive difficulties in ME/CFS. Its mechanism of action, targeting both norepinephrine and dopamine, offers a different pathway for symptom management than many previously studied drugs. While these results are promising, this was a small, short-term trial, and the findings must be replicated in larger studies before solriamfetol can be considered a proven treatment option for the ME/CFS community.

What was researched?

This study evaluated the efficacy and safety of solriamfetol ๐Ÿ’Š, a medication approved for promoting wakefulness in sleep disorders, for treating fatigue and cognitive symptoms in adults with ME/CFS over an 8-week period. The primary goal was to measure changes in fatigue, with a secondary look at executive function.

Why was it researched?

ME/CFS is a debilitating long-term illness with no approved treatments that address the disease directly. Based on the theory that dual norepinephrine-dopamine reuptake inhibitors might be effective for fatigue, researchers wanted to test solriamfetol, which works through this mechanism, to see if it could alleviate key symptoms of ME/CFS.

How was it researched?

This was a phase 4, double-blind, randomized, placebo-controlled trial involving 38 adults who met the 2015 IOM diagnostic criteria for ME/CFS. Participants were randomly assigned to receive either solriamfetol (75 mg, titrated up to 150 mg) or a placebo daily for 8 weeks. Fatigue severity was measured using the Fatigue Symptom Inventory (FSI), and executive function was assessed with the Behavioral Rating Inventory of Executive Function for Adults (BRIEF-A).

What has been found?

After 8 weeks of treatment, the group receiving solriamfetol showed a statistically significant improvement in fatigue severity compared to the placebo group. The medication also led to significant improvements in overall executive function, driven specifically by gains in metacognition (e.g., planning, organization, memory). The drug was well-tolerated, with the most common side effects reported by the treatment group being sleep loss and anxiety.

Discussion

The authors acknowledge several limitations, primarily the studyโ€™s small sample size and limited geographical reach, which means the results require confirmation in a larger, more diverse clinical trial. They noted that while fatigue severity improved, the interference of fatigue in daily life did not significantly change, suggesting a longer treatment period might be needed to see such effects. Additionally, the use of some telehealth visits could have influenced responses, and the rapid dose titration limited the ability to analyze dose-specific effects.

Conclusion & Future Work

The authors conclude that solriamfetol demonstrated good safety and was effective at improving both fatigue severity and specific aspects of executive function in adults with ME/CFS. This suggests that its wakefulness-promoting properties have the potential to benefit patients with this disease. Future research should involve larger, more diverse populations to validate these findings and to investigate optimal dosing strategies.