Shift work disorder is a growing public health concern that affects millions of workers worldwide. While much of the research and clinical guidance has historically focused on night shift workers, a large proportion of the workforce begins work in the very early morning hours. New research published in NEJM Evidence brings long overdue attention to this population. A randomized controlled trial published in January 2026 evaluates solriamfetol as a treatment for excessive sleepiness in early-morning shift work disorder, offering important insights for clinicians, employers, and workers alike.
This article explores the study findings, clinical implications, and broader context of managing sleepiness in early-morning shift workers, drawing from both the original research article and the accompanying editorial published in the current issue of NEJM Evidence.
Shift work disorder is a circadian rhythm sleep disorder characterized by insomnia and excessive sleepiness related to work schedules that conflict with the body’s natural biological clock. While night shifts have long been recognized as disruptive to circadian alignment, early-morning shifts pose their own unique challenges.
Early-morning shift workers typically begin work between 3 a.m. and 7 a.m. This schedule forces individuals to wake during the biological night, often truncating the final and most restorative portion of sleep. Unlike night shift workers, who delay sleep onset, early-morning workers must advance their sleep phase, which can be even more difficult for the human circadian system to accommodate.
According to the editorial published alongside the trial, early-morning shifts are more common than night shifts and are prevalent in industries such as health care, transportation, manufacturing, and public safety. Excessive sleepiness in these workers is associated with impaired attention, reduced productivity, and increased risk of workplace errors and motor vehicle accidents.
Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor approved for the treatment of excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea. Its mechanism of action differs from traditional stimulants and has been associated with improvements in wakefulness without some of the drawbacks seen with older agents.
Prior studies of pharmacologic treatment for shift work disorder have focused almost exclusively on night shift workers. As a result, evidence guiding treatment decisions for early-morning shift workers has been limited. The newly published trial fills an important gap by specifically evaluating solriamfetol in this understudied population.
The study titled Solriamfetol for Excessive Sleepiness in Early-Morning Shift Work Disorder was published on January 27, 2026, in NEJM Evidence. It was a randomized, double-blind, placebo-controlled trial involving 78 adults with early-morning shift work disorder.
Participants worked shifts starting between 3 a.m. and 7 a.m. and had clinically significant excessive sleepiness associated with shift work disorder. They were randomly assigned to receive either solriamfetol or placebo for four weeks.
The primary outcome was objective sleepiness measured by the Maintenance of Wakefulness Test. Secondary outcomes included subjective sleepiness using the Karolinska Sleepiness Scale and global assessments of clinical change from both clinicians and patients.
The trial demonstrated a statistically and clinically significant improvement in wakefulness among participants treated with solriamfetol. After four weeks, patients receiving solriamfetol showed a mean increase of 9.4 minutes in sleep latency on the Maintenance of Wakefulness Test compared with placebo. Longer sleep latency indicates a greater ability to remain awake, making this a meaningful objective improvement.
Subjective sleepiness also improved. Participants treated with solriamfetol reported lower scores on the Karolinska Sleepiness Scale, with a mean difference of minus 1.2 points compared with placebo. This finding suggests that patients not only performed better on objective testing but also felt less sleepy during their waking hours.
Global assessments reinforced these results. Clinicians were significantly more likely to rate patients receiving solriamfetol as improved, and patients themselves reported greater perceived benefit compared with placebo.
Safety outcomes were consistent with the known profile of solriamfetol. Adverse events were reported by 55 percent of participants receiving solriamfetol and 63 percent of those receiving placebo. The most common adverse events in the solriamfetol group were headache and nausea.
Importantly, no new safety concerns were identified in this population of early-morning shift workers. The relatively similar rate of adverse events between treatment and placebo groups suggests that solriamfetol was generally well tolerated over the four-week study period.
The findings have important implications for clinical practice. Early-morning shift workers represent a large and often overlooked segment of patients with shift work disorder. The demonstration that solriamfetol can significantly improve both objective and subjective sleepiness provides clinicians with evidence-based support for considering pharmacologic therapy in appropriate patients.
The accompanying editorial titled Bright and Early…Now Also Awake! highlights the importance of recognizing early-morning shift work disorder as a distinct clinical entity. The editorial notes that forced advancement of sleep timing may pose unique challenges compared with delayed sleep schedules and that targeted research like this trial is essential for developing effective interventions.
Pharmacologic treatment should be considered as part of a comprehensive management plan that also includes sleep hygiene education, circadian-based scheduling strategies, and, when feasible, adjustments to work schedules.
Excessive sleepiness in shift workers has consequences beyond individual health. Impaired alertness is associated with increased risk of workplace accidents, medical errors, and motor vehicle collisions. Early-morning shift workers may be particularly vulnerable during commutes that occur before sunrise, when circadian alertness is at its lowest.
By improving wakefulness and reducing sleepiness, effective treatments like solriamfetol may have downstream benefits for workplace safety and productivity. While the trial was not designed to measure accident rates or performance outcomes, improved alertness is a critical first step toward reducing risk.
Employers and occupational health professionals may find these findings relevant when developing policies to support shift workers, particularly in safety-sensitive roles.
Despite its strengths, the trial has limitations that should be considered. The sample size was modest, and the study duration was relatively short. Long-term safety and efficacy data in early-morning shift workers are still needed.
Additionally, the study focused on a specific wake-promoting agent. Future research should explore how solriamfetol compares with other pharmacologic and non-pharmacologic interventions, as well as how individual differences in circadian biology influence treatment response.
The editorial emphasizes that early-morning shift work disorder remains under-researched and calls for continued investigation into tailored approaches for this population.
The publication of this randomized controlled trial in NEJM Evidence marks an important milestone in the management of early-morning shift work disorder. Solriamfetol significantly improved objective and subjective measures of sleepiness compared with placebo and was generally well tolerated.
For clinicians, the findings provide much needed evidence to guide treatment decisions for early-morning shift workers with excessive sleepiness. For patients, the results offer hope that targeted therapies can help restore alertness and improve quality of life. For employers and policymakers, the study underscores the importance of addressing sleep health as a component of workplace safety.
As shift work continues to be an essential part of modern society, research that recognizes the diversity of work schedules and their unique physiological impacts will be critical. This study represents a meaningful step toward more inclusive and effective care for all shift workers.
This blog article is for educational and informational purposes only and is based on publicly available summaries from the NEJM Evidence homepage and current issue. It does not provide medical advice, diagnosis, or treatment recommendations. Readers should consult qualified health care professionals for individual medical guidance. Access to full articles may require an active subscription to NEJM Evidence.
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