New Clinical Trial Offers Hope for Early-Morning Shift Workers Struggling With Fatigue
For millions of people, the workday begins long before the sun rises. While these early starts are a cornerstone of many essential industries, they often come with a significant biological cost. A new clinical trial led by researchers at Mass General Brigham has found that the wake-promoting drug solriamfetol (Sunosi) can significantly help early-morning shift workers stay alert and perform better on the job.
The findings, published in NEJM Evidence, address a critical gap in sleep medicine. While overnight shifts have been studied extensively, workers who start their day in the pre-dawn hours have been largely overlooked despite facing similar challenges with alertness and safety.
Why Early Shifts Disrupt the Body’s Internal Clock
Roughly one in four workers operates outside a standard 9-to-5 schedule. Many who start their day remarkably early don’t categorize themselves as “shift workers,” viewing their routine simply as an early start. However, they remain at high risk for shift work disorder, a condition characterized by disrupted sleep patterns and persistent daytime sleepiness.
“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 in the Mass General Brigham Department of Medicine. “That makes staying alert extraordinarily difficult, even when they are highly motivated.”
Zitting notes that these workers often face a “double burden”: they struggle with excessive sleepiness during their working hours and then find it difficult to get enough restorative sleep when they finally have the chance to rest.
The Hidden Risks of Shift Work Disorder
Shift work disorder is more than just a feeling of tiredness. it is a clinical condition that can jeopardize both professional performance and personal safety. The condition is linked to several serious concerns, including:
- Reduced Mental Sharpness: Impaired concentration and cognitive function.
- Lower Productivity: A decrease in overall job performance and efficiency.
- Increased Safety Risks: A higher likelihood of workplace injuries and car accidents.
While medications like modafinil are sometimes used to promote wakefulness, they have primarily been studied in overnight workers and can interfere with the ability to sleep later in the day.
Solriamfetol: A Promising Alternative for Alertness
Solriamfetol is already approved for treating excessive sleepiness in patients with narcolepsy and obstructive sleep apnea. Researchers targeted this drug for early-morning workers because it can promote alertness for extended periods without significantly disrupting the user’s subsequent sleep.
The Mass General Brigham study involved 78 early-morning shift workers diagnosed with shift work disorder. Over a four-week period, participants were randomly assigned to take either solriamfetol or a placebo on their workdays. To measure the drug’s efficacy, researchers assessed the participants’ ability to stay awake in a controlled, low-stimulation setting that mimicked their typical work schedule.
Key Findings from the Trial
After four weeks, the results showed clear improvements for those receiving solriamfetol. The treated group was less sleepy and could remain awake longer during simulated work hours. Both the participants and their physicians reported better overall functioning, improved work performance, and an enhanced ability to manage daily tasks.
“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,” 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 Department of Medicine.
Summary of Study Results
- Participant Pool: 78 early-morning shift workers with shift work disorder.
- Duration: 4-week randomized, placebo-controlled trial.
- Primary Outcome: Increased ability to remain awake and alert during simulated work hours.
- Secondary Benefits: Improved daily functioning and better overall work performance.
The Path Forward: Long-Term Research
While these results are promising, the research team emphasized that more work is needed. The current trial was limited to a four-week duration and included otherwise healthy adults. Understanding the long-term effects of solriamfetol for this specific population remains a priority.
The team is currently enrolling participants for a follow-up clinical trial to study the drug’s effects on overnight shift workers, which may support broader approval for the treatment of shift work disorder. This research was funded by Brigham and Women’s Hospital Center for Clinical Investigation, Axsome Therapeutics, and Jazz Pharmaceuticals.
Frequently Asked Questions
What is shift work disorder?
Shift work disorder is a circadian rhythm sleep disorder that occurs when a person’s work schedule conflicts with their internal biological clock, leading to insomnia when they need to sleep and excessive sleepiness when they need to be awake.
Who is solriamfetol (Sunosi) typically prescribed for?
It is currently approved for individuals experiencing excessive sleepiness associated with narcolepsy and obstructive sleep apnea.
Does solriamfetol interfere with nighttime sleep?
According to the researchers, solriamfetol was considered a promising option for early-morning workers specifically because it can promote alertness without significantly disrupting sleep later in the day.