Solriamfetol Shows Promise for Treating Excessive Sleepiness in Early Morning Shift Workers
Key Insights
A clinical trial by Mass General Brigham (search) researchers found that solriamfetol (Sunosi) significantly reduced excessive sleepiness (search) in early morning shift workers with shift work disorder (search).
The four-week study of 78 workers demonstrated that those receiving solriamfetol could stay awake and alert throughout full eight-hour shifts compared to placebo recipients.
This represents the first clinical trial testing a treatment specifically for shift work disorder (search) in early morning workers, addressing a major gap in care for this population.
A new clinical trial has demonstrated that the wake-promoting drug solriamfetol can significantly reduce excessive sleepiness (search) in early morning shift workers, potentially offering the first targeted treatment for a widespread but understudied occupational health challenge. The research, conducted by investigators from Mass General Brigham (search) and published in NEJM Evidence, represents the first clinical trial to test a treatment specifically for shift work disorder (search) in early morning workers.
Study Design and Population
The randomized, placebo-controlled trial enrolled 78 early morning shift workers who met criteria for shift work disorder (search) and reported trouble staying awake at work or falling asleep during rest periods. Participants were divided into two groups, with half receiving solriamfetol each workday for four weeks and half receiving placebo.
"Until now, no clinical trial had tested a treatment for shift work disorder (search) in early-morning shift workers, even though this is the most common type of shift schedule," said senior author Charles A. Czeisler, PhD, MD, chief and senior physician of the Division of Sleep and Circadian Medicine in the Mass General Brigham (search) Department of Medicine.
Significant Clinical Improvements
Researchers measured participants' ability to stay awake in a quiet, dark environment during times when they would normally be working. After four weeks of treatment, workers who received solriamfetol demonstrated significantly improved wakefulness and could stay awake longer during simulated work hours compared to those receiving placebo.
Both the workers and their physicians reported better overall functioning, work productivity, and daily activities in the treatment group. "The improvement we saw is clinically meaningful," Czeisler said. "These workers were able to stay awake and alert throughout a full eight-hour shift, which has real implications for performance, safety, and quality of life."
Addressing a Biological Challenge
Early morning shift workers face unique physiological challenges that distinguish them from other shift workers. "People who start work between 3 a.m. and 7 a.m. are waking up at a time when the brain is biologically programmed to sleep," explained first author Kirsi-Marja Zitting, PhD, an investigator with the Division of Sleep and Circadian Medicine. "That makes staying alert extraordinarily difficult, even when they are highly motivated."
The researchers noted that these workers often experience a "double burden" of excessive sleepiness (search) during work hours and difficulty obtaining adequate sleep when they have opportunities to rest. This pattern can lead to impaired thinking, reduced job performance, motor vehicle crashes, and workplace accidents.
Drug Profile and Rationale
Solriamfetol, marketed under the brand name Sunosi, is currently approved by the FDA to treat excessive sleepiness (search) in people with obstructive sleep apnea (search) and narcolepsy (search). The drug's ability to maintain wakefulness for extended periods without compromising subsequent sleep made it a logical candidate for testing in early morning shift workers, according to the researchers.
This distinguishes solriamfetol from other wake-promoting drugs such as modafinil, which are commonly used for shift work disorder (search) but were only tested in overnight shift workers and can interfere with later sleep.
Clinical Significance and Future Directions
About a quarter of the workforce operates outside traditional 9-to-5 schedules, with many working early morning shifts. Researchers noted that many people who start work very early do not consider themselves "shift workers" and may view their schedules as simply an early start to a normal workday, despite being at risk for shift work disorder (search).
"Shift workers are essential to how our society functions, yet they often pay a hidden biological cost," Czeisler said. "This study shows we can do better for them."
The researchers acknowledged that early morning shift workers remain understudied, and the four-week trial focused on otherwise healthy adults, meaning longer-term effects require further investigation. The team is currently recruiting participants for a follow-up clinical trial of solriamfetol in overnight shift workers to support its potential approval as a treatment for shift work disorder (search) across different shift patterns.