Mayo Clinic Proceedings has published data from a pivotal phase III trial, which demonstrated that Nuvigil (armodafinil) Tablets [C-IV] significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder (SWD).
Nuvigil, the longer-lasting isomer of modafinil, is indicated to improve wakefulness in patients with excessive sleepiness associated with shift work disorder, treated obstructive sleep apnea and narcolepsy. These data were part of the new drug application approved by the FDA in 2007.
The phase III 12-week, randomised, double-blind, placebo-controlled study evaluated 254 permanent or rotating shift workers with shift work disorder at 42 sleep research centers in the US and Canada.
In the study the patients received Nuvigil (150mg) or a placebo at approximately one hour before each night shift. During weeks four, eight and 12, patients spent a night shift in the sleep laboratory, where investigators assessed patients’ physiological propensity to fall sleep during night shift hours and clinicians’ impression of disease severity, and patient-reported level of sleepiness.
In the study, patients wakefulness improved over the course of the trial in patients taking Nuvigil (by 3.1 minutes) versus those on placebo (by 0.4 minutes). This primary endpoint was evaluated by the multiple sleep latency test, which measured patients’ time to fall asleep at specific times during the night shift.
79% of patients showed improvement after receiving Nuvigil as compare to 59% in placebo, as evaluated by Clinical Global Impressions of Change (CGI-C), which measured overall wellbeing as related to sleepiness during night shifts including the commute to and from work.
Thomas Roth, an investigator in the study, said: “These findings are important, given that approximately 15% of US employees work during nighttime hours and many may have symptoms of shift work disorder. The results establish the potential benefits of armodafinil (Nuvigil) for patients with excessive sleepiness associated with shift work disorder.”