A recent clinical trial has found that solriamfetol is effective in helping early-morning workers combat fatigue and stay alert during shifts. Research indicates that many individuals who begin work at 4 a.m. often do not see themselves as shift workers, a perception that has historically left them without focused treatment options.
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According to research, approximately one in four workers in the U.S. operate outside the typical 9-to-5 schedule, and significantly more start their day between 3 and 7 a.m. compared to those working overnight. Night-shift workers have been the primary focus of sleep medicine research, while early starters have remained largely unstudied, despite their increasing numbers. Dr. Charles A. Czeisler, chief of the Division of Sleep and Circadian Medicine at Mass General Brigham, emphasized that this group is more common yet overlooked in clinical trials for shift work disorder.
Individuals who wake up for early shifts often do so at their biological low point, making it challenging to remain alert. Dr. Kirsi-Marja Zitting, the study's first author, explained that starting work at such early hours is at odds with the natural circadian rhythm, leading to increased risks of cardiovascular disease, road accidents, and chronic fatigue.
Solriamfetol, marketed as Sunosi, works by inhibiting the brain's reabsorption of certain chemicals associated with wakefulness. Already approved for the treatment of narcolepsy and obstructive sleep apnea, it was tested in this study with 78 early-morning workers aged 18 to 64, all of whom worked a minimum of 20 hours weekly and started shifts between 3 and 7 a.m.
In a controlled setting, half of the participants received 150 mg of solriamfetol, while the other half were given a placebo. The effectiveness was evaluated through a standard alertness test, where those on solriamfetol exhibited an average increase in wakefulness of 12.5 minutes, compared to just 3.1 minutes in the placebo group, creating a statistically significant difference of 9.4 minutes.
Dr. Czeisler pointed out that the results are clinically significant, allowing workers to remain alert throughout an eight-hour shift, which has implications for their performance and safety. Participants taking solriamfetol also reported feeling 1.2 points less sleepy on average and were over three times more likely to be perceived as improved by both doctors and patients.
The side effects associated with solriamfetol were mild, with about half of the users reporting adverse effects, primarily headaches and nausea, similar to the placebo group.
This trial marks a significant step, being the first randomized clinical study focusing on treatment for early-morning workers with shift work disorder. With promising results, there are plans for a follow-up trial to include overnight workers as part of the process for potentially formalizing solriamfetol for this condition. This represents a tangible treatment option for workers who have traditionally been advised simply to adjust their sleeping habits. The outcomes of the study are published in the journal NEJM Evidence.