A recent study published in the New England Journal of Medicine shows that solriamfetol significantly decreases both objective and subjective sleepiness in early-morning shift workers with shift work disorder (SWD). This randomized, double-blind, placebo-controlled trial enrolled 78 participants aged 18 to 64 who worked at least 20 hours per week on shifts starting between 3:00 and 7:00 a.m.
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After four weeks of treatment, solriamfetol was associated with a 9.4-minute longer sleep latency on the Maintenance of Wakefulness Test (MWT) compared to placebo, a statistically significant outcome (P<0.001). Additionally, subjective assessments of sleepiness showed a decrease of −1.2 on the Karolinska Sleepiness Scale (KSS), with better ratings reported by both clinicians (odds ratio [OR] 3.7) and patients (OR 4.2).
However, the study also noted limitations. The demographics of early-morning shift workers with SWD remain unclear, and the trial's population may not accurately reflect this broader group. Participants were chosen for minimal comorbidities and did not undergo pre-MWT polysomnography. Moreover, objective workplace performance measures were not assessed, though solriamfetol was linked to greater reported work productivity and reduced functional impairment due to sleepiness.
Adverse events were noted in 55% of those taking solriamfetol and 63% of the placebo group, with headaches and nausea being the most common side effects.
Led by Kirsi-Marja Zitting, PhD, from Brigham and Women’s Hospital, the research adds to previous findings regarding solriamfetol's potential benefits in managing excessive daytime sleepiness, particularly in patients with obstructive sleep apnea. A related study indicated improvements in neuropsychological outcomes among such patients after solriamfetol treatment.