At the Society of General Internal Medicine’s 34th Annual Meeting in Phoenix, Ariz, Cephalon Inc presented positive results from a phase IV trial of nearly 400 people with excessive sleepiness associated with shift work disorder.
In the trial, Nuvigil (armodafinil) Tablets [C-IV] improved shift workers’ overall clinical condition late in their shifts (4 AM to 8 AM), including the commute home, compared to placebo. The key secondary endpoint of the study was to assess global function, as measured by the Global Assessment of Functioning (GAF), and patients taking Nuvigil experienced a greater improvement in GAF score compared to those patients taking placebo.
“This study is important because up to 25% of people who work nights, early mornings, or other nontraditional shifts may be affected by shift work disorder. This condition affects their ability to function at work and at home, but they still need to do their jobs. The results of this study show an improvement in condition as well as a reduction in the impairment of patients treated with Nuvigil for excessive sleepiness associated with shift work disorder when compared to placebo,” said Milton K. Erman, MD, study lead investigator. Erman is a clinical professor of psychiatry at the University of California San Diego and president, Pacific Sleep Medicine Services, San Diego. “This study reinforces the need for health care professionals to learn more about this disorder and about how treatment options like Nuvigil may be of help in managing excessive sleepiness due to shift work disorder.”
The most frequently reported adverse events in this study are similar to those described in the Nuvigil prescribing information, and include headache, nausea, and insomnia. There were no serious adverse events observed in patients taking Nuvigil in this study. This is the first presentation of these data at a medical meeting, and additional results will be submitted for future publications and presentations.