Even though far more people work early morning shifts than overnight shifts, many suffer from severe fatigue associated with shift work disorder. This condition can interfere with concentration, work performance, and safety. A new clinical trial led by researchers at Massachusetts General Brigham University found that the wakefulness-promoting drug solriamfetol (Sunosi) can help workers feel more alert during the early morning shift. The survey results are NEJM Records.
“Until now, no clinical trials have tested treatments for shift work disorder in early morning shift workers, even though this is the most common type of shift work,” said lead author Charles A. Zeisler, M.D., chief and senior physician in the Division of Sleep and Circadian Medicine at the Massachusetts General Brigham Medical School. “This study addresses a major gap by focusing on workers who start their day at a time when most people are still asleep.”
Why does working an early shift disrupt your body clock?
Approximately one in four employees work outside of the standard 9-to-5 schedule, including those who start work early in the morning. Many people with this type of schedule do not consider themselves to work shifts, but think of their routine as simply starting their day earlier than usual. However, they may still face a high risk of shift work disorder, which involves disrupted sleep patterns and persistent daytime sleepiness.
“If you start work between 3 a.m. and 7 a.m., you’re awake at a time when your brain is biologically programmed to sleep, which makes it very difficult to stay alert, even when you’re highly motivated,” said lead author Kirsi Marja Zitting, Ph.D., a researcher in the Department of Sleep and Circadian Medicine at Massachusetts General Brigham Medical School. “They often suffer from the double burden of being excessively sleepy during work hours and not getting enough sleep when they have the opportunity to rest.”
Shift work disability health and safety risks
Shift work disorder is associated with a variety of serious concerns, including decreased mental acuity, reduced productivity, increased risk of road accidents, and increased workplace injuries. Drugs such as modafinil are sometimes used to promote wakefulness, but these drugs have been primarily studied in night shift workers and can interfere with sleep later in the day.
Solriamfetol, the drug evaluated in this study, is already approved to treat excessive sleepiness in patients with obstructive sleep apnea and narcolepsy. The researchers thought this was a promising option because it could promote wakefulness for longer periods of time without significantly interfering with subsequent sleep.
Clinical trials show improved attention and performance
The study involved 78 early morning shift workers diagnosed with shift work disorder. Participants were randomly assigned to take either solriamfetol or a placebo on weekdays for four weeks. Researchers assessed people’s ability to stay awake at a time that aligned with their typical work schedule in a controlled, low-stimulation environment. Participants also reported on their daily lives and met regularly with a clinician.
After four weeks, patients receiving solriamfetol showed clear improvement. They felt less sleepy and were able to stay awake longer during simulated working hours. Both participants and physicians noticed improved overall functioning, improved work performance, and increased ability to manage daily tasks.
“The improvements we saw are clinically meaningful. These workers were able to stay awake and alert throughout their entire eight-hour shift, which has a huge impact on performance, safety, and quality of life,” Ciesler said. “Shift workers are essential for our society to function, but they often pay a hidden biological cost. This study shows we can do better for them.”
Long-term effects require further research
The researchers stressed that early morning shift workers have not been widely studied, and that the study was only four weeks long and included otherwise healthy adults. Further research is needed to understand the long-term effects of treatment. The research team is currently enrolling participants in a follow-up clinical trial studying solriamfetol in night shift workers, which could help support widespread approval for the treatment of shift work disorder.
In addition to Zitting and Zeisler, the authors of Brigham Mass General include Katherine R. Gilmore, Brandon J. Lockyer, Wei Wang, Nicholas C. Issa, Stuart F. Quan, Jonathan S. Williams, and Jeanne F. Duffy. Other authors include Eileen B. Leary.
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
