Armodafinil improves both late-in-shift sleepiness and functionality during the critical circadian nadir period of 4 am to 8 am in night shift workers.
PHOENIX—Armodafinil improves wakefulness and functionality in patients with shift work disorder, according to research presented at the 34th Annual Meeting of the Society of General Internal Medicine.
Milton Erman, MD, President of Pacific Sleep Medicine Services in San Diego, and colleagues examined the effect of armodafinil on wakefulness and global functioning in people who work shifts outside the normal workday (6 am to 6 pm) and who experience symptoms of shift work disorder, including excessive sleepiness and impaired functioning.
“Shift workers are at approximately three times greater risk for occupational accidents compared with individuals who work traditional daytime shifts,” the authors stated. “[They] often experience chronic sleep problems and are almost twice as likely to fall asleep at work.”
Majority of Shift Workers Reported Moderate Illness Severity
The investigators enrolled 383 shift workers (mean age, 36) who had worked five or more shifts per month between 10 pm and 8 am. Participants were randomized to receive either 150 mg of armodafinil or placebo prior to the start of a night shift. Improvement was determined by higher functioning score, lower rating of illness severity, and lower score on the Karolinska Sleepiness Scale (KSS). Evaluations were conducted at baseline, three weeks, and six weeks; measurements were taken at the beginning of a night shift and at two-hour increments between the hours of 4 am and 8 am, a time period that included their commute home.
At baseline, 111 of the 193 patients receiving armodafinil were rated as “moderately ill,” 63 were “markedly ill,” 18 were “severely ill,” and one was “among the most extremely ill.” The majority of participants worked in the fields of health care, protective services, and transportation.
Armodafinil Versus Placebo
“The proportion of patients with improved late-in-shift [illness severity] was significantly greater in the armodafinil group compared with the placebo group at final visit, as well as at weeks 3 and 6,” the authors reported. In addition, more patients in the armodafinil-treated group were rated as “much improved” and “very much improved” compared with placebo-treated patients.
Late-in-shift subjective sleepiness decreased greatly in the armodafinil group, as demonstrated by a mean reduction of 2.9 points on the KSS score for the drug-treated group, compared with a mean 1.9-point reduction in the placebo group.
Functional status was also significantly improved in the drug group compared with the placebo group, and the mean change in functionality scores was 4.3 points higher in the armodafinil group.
“Armodafinil was generally well tolerated,” the researchers wrote. “No new safety signals were identified during this study.” Adverse events were reported in less than 5% of patients receiving armodafinil; the most common adverse events that patients experienced were headache, nausea, and insomnia.
“In this large study of patients working actual night shifts, armodafinil significantly improved shift-workers’ wakefulness late in shift during the critical circadian nadir period from 4 am to 8 am,” the authors concluded.
—Ariel Jones