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news.Cephalon Nuvigil (armodafinil) tablets demonstrated improvement in shift-workers' overall clinical condition late in their shifts (i.e., 4:00 am to 8:00 am), including the commute home, compared to placebo in a Phase IV trial.
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NUVIGIL is indicated for the improvement of wakefulness in patients with excessive sleepiness associated with shift work disorder (SWD), treated obstructive sleep apnea (OSA), or narcolepsy.
The six-week, double-blind and placebo-controlled study evaluated 383 patients suffering from excessive sleepiness linked with shift work disorder at 45 sites across the US.
In the trial, 77% of patients taking the recommended Nuvigil dose of 150mg improved, compared to 57% of patients taking placebo.
Cephalon said the patients treated with Nuvigil experienced a 9.5 point improvement over baseline in the Global Assessment of Functioning, to mean scores of 72.6 at the final visit, compared to a 5.2 point improvement to means scores of 67.9 in those taking placebo at final visit.
Study lead investigator Milton Erman said 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.
"This study reinforces the need for healthcare 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," Erman said.