A new clinical trial from Mass General Brigham found that a drug approved for other indications helped early morning shift workers with shift work disorder stay more alert.
Key takeaways:
- A clinical trial found that solriamfetol significantly reduced sleepiness and improved alertness in early morning shift workers with shift work disorder.
- The wake-promoting drug, currently approved for obstructive sleep apnea and narcolepsy, allowed workers to stay awake during simulated shifts without disrupting later sleep.
- Researchers are now recruiting for a follow-up clinical trial of solriamfetol in overnight shift workers to support its approval as a treatment for shift work disorder.
A new clinical trial by investigators from Mass General Brigham found that the wake-promoting drug solriamfetol (Sunosi) helped early morning shift workers with shift work disorder stay more alert. The results are published in NEJM Evidence.
About a quarter of the workforce labors outside the traditional 9-to-5 schedule, including early morning shifts. Researchers note many people who start work very early do not think of themselves as shift workers and may view their schedules as an early start to a normal workday. Yet, many are at risk of developing shift work disorder, a medical condition characterized by sleep disturbances and excessive daytime sleepiness.
“People who start work between 3 am and 7 am are waking up at a time when the brain is biologically programmed to sleep. That makes staying alert extraordinarily difficult, even when they are highly motivated,” says Kirsi-Marja Zitting, PhD, first author and investigator with the division of sleep and circadian medicine in the Mass General Brigham department of medicine, in a release. “They are often dealing with a double burden—excessive sleepiness during work hours and difficulty sleeping enough when they have the chance to rest.”
“Until now, no clinical trial had tested a treatment for shift work disorder in early-morning shift workers, even though this is the most common type of shift schedule,” says Charles A. Czeisler, PhD, MD, senior author, chief, and senior physician of the division of sleep and circadian medicine in the Mass General Brigham department of medicine, in a release. “This study addresses a major gap by focusing on the workers who start their day when most people are still asleep.”
People with shift work disorder face higher risks of impaired thinking, reduced job performance, motor vehicle crashes, and workplace accidents. Wake-promoting drugs such as modafinil are commonly used for shift work disorder but were only tested in overnight shift workers and can make it harder to sleep later in the day.
The drug in this study, solriamfetol, is approved to treat excessive sleepiness in people with obstructive sleep apnea and narcolepsy. Its ability to keep people awake for hours—without costing them sleep later—made it a logical option to test in early morning shift workers, the researchers note.
The study enrolled 78 early morning shift workers who met the criteria for shift work disorder. Half took solriamfetol each workday for four weeks, and half took a placebo. Researchers measured how long the workers could stay awake in a quiet, dark environment during times when they would normally be working. They also met with doctors and gave reports of their daily functioning.
After four weeks, workers who received solriamfetol were significantly less sleepy and were able to stay awake longer during simulated work hours. Both the workers and their doctors reported better overall functioning, work productivity, and daily activities.
“The improvement we saw is clinically meaningful. 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,” says Czeisler in a release. “Shift workers are essential to how our society functions, yet they often pay a hidden biological cost. This study shows we can do better for them.”
The researchers note that early morning shift workers are not well studied, and that the four-week study focused on otherwise healthy adults, meaning longer-term effects still need to be explored. The team is currently recruiting for a follow-up clinical trial of solriamfetol in overnight shift workers to support its approval as a treatment for shift work disorder.
