J Psychopharmacol

Solriamfetol shows promise for ME/CFS-related fatigue after 8 weeks of treatment

September 18, 2025

Solriamfetol may offer a novel therapeutic option for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)-related fatigue and cognitive dysfunction. Its wakefulness-promoting mechanism could help address a key unmet need in this population, though further studies are warranted to assess long-term efficacy and impact on post-exertional malaise.

Study details: This phase 4, double-blind, randomized, placebo-controlled trial (NCT04622293) evaluated solriamfetol, a dual norepinephrine-dopamine reuptake inhibitor, in 38 adults aged 18 to 65 with ME/CFS. Participants received either 75 mg solriamfetol (titrated to 150 mg as needed) or placebo over 8 weeks. Primary and secondary outcomes included changes in Fatigue Symptom Inventory (FSI) and the Behavioral Rating Inventory of Executive Function–Adult (BRIEF-A), respectively.

Results: At week 8, solriamfetol significantly improved FSI severity scores compared with placebo (p=.039), though no difference was seen at week 6 (p=0.270). BRIEF-A global executive composite scores also improved at week 8 (p=.012), driven by gains in metacognition (p=.004). Behavioral regulation didn’t differ significantly (p=0.574). Solriamfetol was well tolerated; common adverse events included sleep loss and headache.

Source:

Young JL, et al. (2025, September 16). J Psychopharmacol. Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment. https://pubmed.ncbi.nlm.nih.gov/40958377/