Solriamfetol Boosts Alertness in Early Shift Workers

A significantly larger number of individuals commence their workdays during very early morning hours compared to those on overnight shifts, but numerous employees battle intense fatigue associated with shift work disorder. This prevalent issue can severely hamper focus, professional efficiency, and overall safety on the job. Researchers from Mass General Brigham spearheaded a recent clinical trial that demonstrated the wakefulness-enhancing medication solriamfetol, marketed as Sunosi, effectively increased alertness levels among workers starting their shifts in the early morning. The detailed results of this investigation appeared in NEJM Evidence.

Addressing a Key Gap in Treatment for Early Risers

"Prior to this research, no dedicated clinical trial had evaluated any therapeutic intervention specifically for shift work disorder among early-morning shift employees, despite this being the predominant form of non-standard scheduling," explained senior author Charles A. Czeisler, PhD, MD, who serves as chief and senior physician in the Division of Sleep and Circadian Medicine within the Mass General Brigham Department of Medicine. "Our study fills a critical void by targeting the very group of workers who begin their shifts while the majority of the population remains asleep."

How Early Morning Schedules Throw Off the Internal Clock

Approximately one-quarter of the workforce deviates from the conventional 9-to-5 routine, encompassing those who launch into their duties at the crack of dawn. Countless individuals adhering to such timetables do not identify as traditional shift workers; rather, they perceive their pattern as merely an earlier start to the day. Nevertheless, they remain highly susceptible to shift work disorder, characterized by irregular sleep cycles and unrelenting sleepiness throughout daylight hours.

"Employees beginning their shifts anytime from 3 a.m. to 7 a.m. are rousing themselves during the period when their brains are naturally wired for deep sleep. This biological mismatch renders maintaining wakefulness exceptionally challenging, regardless of their drive and determination," noted lead author Kirsi-Marja Zitting, PhD, a researcher in the Division of Sleep and Circadian Medicine at Mass General Brigham's Department of Medicine. "These workers frequently endure a dual challenge: overwhelming drowsiness while on duty and struggles to accumulate sufficient rest during their off-hours."

Significant Health and Safety Hazards Posed by Shift Work Disorder

Shift work disorder correlates with numerous grave complications, such as diminished cognitive acuity, decreased output, heightened chances of vehicular collisions, and elevated incidences of occupational injuries. While wake-promoting agents like modafinil are occasionally prescribed to foster alertness, their primary evaluations have centered on night-shift personnel, and they may disrupt subsequent sleep opportunities.

In this particular investigation, solriamfetol emerged as the focal drug. It has garnered approval for combating excessive daytime somnolence in patients suffering from obstructive sleep apnea or narcolepsy. The study team viewed it as a viable candidate due to its capacity to sustain heightened vigilance over prolonged durations without markedly affecting nighttime repose.

Trial Results Reveal Enhanced Vigilance and Functionality

The trial encompassed 78 participants who were early morning shift workers officially diagnosed with shift work disorder. These individuals were randomly allocated to receive either solriamfetol or a placebo exclusively on their working days throughout a four-week duration. Investigators measured their wakefulness maintenance in a regulated, minimal-stimulation environment that replicated their usual shift timings. Subjects also provided accounts of their everyday activities and engaged in routine consultations with medical professionals.

Following the four-week regimen, the solriamfetol group exhibited unmistakable advancements. They experienced reduced sleepiness and managed to stay awake for extended periods during mock work sessions. Feedback from both the participants themselves and their physicians highlighted superior general functioning, elevated job efficacy, and improved competence in handling routine responsibilities.

"The enhancements observed carry substantial clinical relevance. These employees could sustain wakefulness and attentiveness across an entire eight-hour shift, carrying profound consequences for their productivity, safety measures, and personal well-being," stated Czeisler. "Shift workers form the backbone of societal operations, yet they frequently bear an unseen physiological toll. Our findings indicate that superior support options are achievable."

Future Investigations into Prolonged Usage Required

The research team underscored that early morning shift workers have historically received limited scientific attention, with the present trial spanning just four weeks and involving healthy adults without comorbidities. Further studies are essential to elucidate the sustained impacts of this therapy. Currently, the group is recruiting for a subsequent trial examining solriamfetol's effects in overnight shift workers, potentially paving the way for expanded indications in shift work disorder management.