Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment. — CFSMEATLAS
Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment.
Young, Joel L, Powell, Richard N, Powell, Anna et al. · Journal of psychopharmacology (Oxford, England) · 2025 · DOI
Quick Summary
Researchers tested whether a medication called solriamfetol could help reduce fatigue in people with ME/CFS. In this 8-week study, some patients received the medication (starting at 75mg and potentially increasing to 150mg) while others received a placebo. By week 8, patients taking solriamfetol reported significantly less severe fatigue compared to those on placebo, and they also showed improvements in thinking and memory abilities. The medication was generally well tolerated, though some people experienced sleep problems and headaches.
Why It Matters
This is the first controlled trial demonstrating that solriamfetol may effectively reduce fatigue severity in ME/CFS patients, addressing a condition with no FDA-approved treatments. The findings are significant because they suggest a dual norepinephrine-dopamine mechanism may help address both fatigue and cognitive symptoms—two core debilitating features of ME/CFS. This study opens a potential new therapeutic avenue and provides evidence for larger-scale clinical trials.
Observed Findings
Solriamfetol significantly improved Fatigue Symptom Inventory severity scores compared to placebo at week 8 (p=0.039), but not at week 6 (p=0.270).
Solriamfetol improved executive function on the BRIEF-A global composite at week 8 (p=0.012), driven by improvements in metacognition (p=0.004).
Behavioral regulation index scores showed no significant difference between solriamfetol and placebo (p=0.574).
The most common adverse events were sleep loss and headaches, with the medication demonstrating overall good tolerability.
Improvement in fatigue severity appeared to require the full 8-week treatment period.
Inferred Conclusions
Solriamfetol has potential as a treatment for fatigue symptoms in ME/CFS patients, likely through dual norepinephrine-dopamine reuptake inhibition and wakefulness-promoting mechanisms.
The medication may address not only fatigue but also cognitive dysfunction, specifically higher-order thinking and planning abilities.
Solriamfetol demonstrates an acceptable safety profile in this patient population, warranting further investigation in larger trials.
Remaining Questions
What is the optimal dosing regimen and duration of treatment for maximum benefit in ME/CFS patients?
What This Study Does Not Prove
This small 8-week study does not establish long-term safety or efficacy beyond 8 weeks, nor does it prove solriamfetol is effective for all ME/CFS patients or at all disease severity levels. The study cannot determine whether improvements result from direct disease modification or symptom management alone. Generalizability is limited by the small sample size and specific patient population enrolled; results may not apply to all ME/CFS presentations.
Tags
Symptom:Cognitive DysfunctionFatigue
Method Flag:PEM Not DefinedWeak Case DefinitionSmall Sample
Does solriamfetol benefit persist beyond 8 weeks, and are there long-term safety concerns with extended use?
Which ME/CFS patient subgroups are most likely to respond to solriamfetol—does baseline symptom severity, genetic factors, or disease phenotype predict response?
How does solriamfetol's mechanism compare to other potential treatments, and can it be combined with other therapies?