New Study Highlights Solriamfetol's Benefits for Early Morning Workers Battling Shift Work Disorder

Early morning shifts are increasingly common, yet many who work these hours experience significant fatigue linked to shift work disorder, which can impair concentration and safety. Recent research from Mass General Brigham demonstrates that solriamfetol (Sunosi), a wake-promoting drug, enhances alertness in these workers, marking a significant step for this often-overlooked demographic.

The Shift Work Dilemma

Consider the reality faced by millions working irregular hours. Approximately 25% of employees find themselves outside the traditional 9 to 5 schedule, with some starting their shifts as early as 3 a.m. These workers come from diverse sectors—healthcare, manufacturing, and transportation, just to name a few. Yet, many don't identify as "shift workers" in the traditional sense, which adds another layer to their challenges. While they earn a paycheck for their early hours, they often do so at the expense of their health and well-being.

Dr. Charles A. Czeisler, the study's senior author and chief physician of the Division of Sleep and Circadian Medicine, highlights a significant oversight in prior research. He pointed out, "Until now, no clinical trial focused specifically on early-morning shift workers despite their prevalence." This gap is troubling. Many of these employees face circadian misalignment that doesn't just affect them but can have broader implications for workplace safety. Fatigue can lead to diminished productivity and a higher likelihood of accidents. Employers and society at large should not overlook this issue—it's more significant than many realize.

Understanding Shift Work Disorder

Dr. Kirsi-Marja Zitting, the study's first author, explains that workers starting between 3 and 7 a.m. encounter a physiological challenge. They wake when their bodies are still inclined to sleep, making alertness a considerable hurdle. The internal clock simply hasn't adjusted, leading to excessive fatigue during critical work hours and insufficient sleep during downtime. And this is the part most people overlook: the mental and physical toll can extend far beyond the workplace, potentially spilling over into personal lives.

Shift work disorder is linked with a range of adverse outcomes. Studies show this condition can lead to decreased mental acuity, impaired judgment, and a pronounced risk for accidents, along with chronic conditions like depression and anxiety. While several medications like modafinil have been stitched into treatment protocols for night workers, the existing studies have largely neglected early morning workers. In this regard, solriamfetol stands apart for its unique implications.

Focus on Solriamfetol

In the recent trial, solriamfetol was carefully selected due to its existing approval for excessive sleepiness associated with conditions like obstructive sleep apnea and narcolepsy. What's particularly intriguing about solriamfetol is its promise: it improves wakefulness without significantly interfering with post-work sleep. This is a significant factor, especially for early morning workers who need that rest when they finish their shifts.

Clinical Trial Results Show Promise

The study included 78 early shift workers diagnosed with shift work disorder, who were randomly assigned to receive solriamfetol or a placebo over a duration of four weeks. The controlled, low-stimulation environment mimicked their typical working hours, making the findings more relevant to real-world conditions. Participants self-reported daily functioning, which added a valuable subjective dimension to the trial, complemented by regular clinical assessments.

The results were noteworthy: participants taking solriamfetol reported significant improvements in wakefulness throughout their work shifts. Clinicians observed marked enhancements in overall functioning, work performance, and daily responsibilities management. Dr. Czeisler reflects on this, saying, "The level of improvement observed is clinically significant." It's clear these early morning workers play a critical role in keeping society operational, but often, they face hidden biological costs that can't be ignored. "This research shows the potential for better support," he adds, highlighting the opportunity for advancements in treatment.

Future Research Directions

While this study represents a pivotal first step, it does have limitations. Early morning shift workers remain an underexplored group, and the current trial involved a relatively short timeframe with otherwise healthy participants. Future research will need to dig deeper to uncover long-term effects and possibly expand to include a wider demographic of shift workers. The authors are gearing up for a follow-up trial that aims to test solriamfetol on overnight shift workers—a step that could further extend the drug’s applicability.

Alongside Zitting and Czeisler, other contributors to the research from Mass General Brigham included Katherine R. Gilmore, Brandon J. Lockyer, Wei Wang, Nicolas C. Issa, Stuart F. Quan, Jonathan S. Williams, and Jeanne F. Duffy. Another author, Eileen B. Leary, also played a role in this comprehensive research.

Implications for the Future

The implications of this research could be far-reaching. If solriamfetol proves effective for a broader range of shift workers, it sets the stage for a shift in how employers support their staff. If you’re working in this space, this trial serves as a reminder that early-morning workers need acknowledgment and resources. The findings underline that addressing the needs of this often-overlooked demographic is not just a health issue; it's a matter of workplace safety and efficiency.

This study was funded by Jazz Pharmaceuticals, Axsome Therapeutics, and Brigham and Women's Hospital Center for Clinical Investigation; NCT04788953(2021-03-09) https://clinicaltrials.gov/study/NCT04788953

Materials were provided by Brigham and Women's Hospital. Note: Content may be edited for style and length.