Preprint Solriamfetol improves daily fatigue symptoms in adults with [ME/CFS] after eight weeks of treatment, 2025, Young et al

Nightsong

Nightsong

Senior Member (Voting Rights)
Abstract:
Background: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a long-term illness with no treatment options that address the disease directly. Solriamfetol is a selective dual norepinephrine-dopamine reuptake inhibitor that promotes wakefulness in obstructive sleep apnea and narcolepsy.

Aims: This study evaluated the efficacy and safety of solriamfetol for fatigue symptoms in adults with ME/CFS with 8 weeks of treatment. Methods: This was a phase 4, double-blind, randomized, placebo-controlled trial of solriamfetol in adults with ME/CFS. Eligible participants were randomly assigned to receive 75mg (titrated to 150mg as needed) solriamfetol or placebo. Participants completed a battery of assessments at weekly visits. The primary outcome was Fatigue Symptom Inventory (FSI) scores, and the secondary outcome measure was Behavioral Rating Inventory of Executive Function for Adults (BRIEF-A), at weeks 6 and 8. T-tests assessed the differences in mean change from baseline between solriamfetol and placebo. Adverse events were monitored throughout the study.

Results: At week 8 (p = .039), but not week 6 (p = .270), solriamfetol improved FSI severity compared to placebo. On the BRIEF-A global executive composite, solriamfetol improved more than placebo at week 8 (p = .012), driven by improved metacognition index (p = .004), but not behavioral regulation index (p = .574). Solriamfetol was well tolerated, with most common AEs being sleep loss and headaches.

Conclusions: Solriamfetol demonstrated good safety and efficacy in improving fatigue and executive functioning in patients with ME/CFS. As a dual norepinephrine-dopamine reuptake inhibitor and wakefulness-promotion, solriamfetol has the potential to improve fatigue symptoms of ME/CFS.

Link | PDF (PsyArXiv preprint, April 2025, open access)
 
I wish they had adressed PEM in the abstract. Since PEM is the most debilitating symtom it is very important to know how staying awake more impacts PEM.

If I don’t rest/sleep enough I get PEM. So for me, a medication that keeps me awake and gives me more energy one day, is useless if I get PEM the next day.


(I nap 2-3 hours every day. If I don’t nap, my sleep is worse during the night.)
 
No mention of PEM anywhere in the document.

"Safety outcomes

In total, 14 (36.8%) patients randomized to receive solriamfetolor placebo reported at least one AE. Two participants in the placebo group withdrew due to AEs; both reported sleep loss and one also experienced headaches, dizziness, and anxiety. Remaining patients who received solriamfetol and placebo reported a total of 13 and 16 AEs, respectively (Table 4). The most common AE reported in patients who received solriamfetol was sleep loss (6 instances, 3 patients), whereas the AE experienced by the greatest number of patients in this group was anxiety (4 instances, 4 patients). In contrast, the most common AE reported in patients who received placebo was headaches (8 instances, 4 patients), which was also the AE experienced by the greatest number of patients in this group. There were no new safety signals reported."

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The concern here would be that a drug that is supposed to wake you up will break blinding because being woken up will tell you that you are on the right drug.

I am not sure what they mean by phase 4 trial - which is usually a trial of a drug after it has been licensed for the condition of the trial. This drug may be licensed for other things but this looks like a phase 2 study to me.
 
InitialConditions said:
I don't think a band-aid stimulant is what we need.
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Given that dexamphetamine, methylphenidate rarely work in ME/CFS and Modafinil is a useless drug for anything, I do not think this drug will work but maybe worth a go if it is a little different makeup being a possible NDRI.
 
With ME/CFS any trial really needs longer term follow, as others have already mentioned where there is PEM there risks in anything that produces a shorter term feeling better places the individual at risk of longer term deterioration due to over exertion.

Feeling better is of value in itself, but not at the cost of later significant relapse.
 
Can't muster any enthusiasm for this. Am surprised that Young thinks we need "wakefulness-promotion".

When I was mild, I was trialled on two SNRIs (for ME/CFS, I did not have depression) and they felt like the opposite of what I needed. One made me insomniac, restless and constipated - very unpleasant. I was getting 3-4 hours sleep and then heading to work.

I was whipped off that one by the doctor who wanted me to go straight onto another. I said that I'd be happy to try the other when the side effects of the first had gone. I tried the other a few months later. I don't remember it making me insomniac, but I couldn't say for sure if it made me restless or not. It was terrible for my digestive system though, first constipation, then diarrhoea, and I came off it. It had no beneficial effects. My ME/CFS continued to get worse while on it, indeed, I had quite a dramatic drop in functioning while on it, but was doing GET and CBT at the same time so who knows what caused what or if I was just going to get worse anyway.

I appreciate that this drug affects dopamine too. But you won't catch me going near anything that inhibits reuptake of norepinephrine again, nor anything anticholinergic.
 
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