Cephalon's Phase IV clinical trial of Nuvigil (armodafinil) tablets [C-IV]showed difference in improvement in overall clinical condition related to late-shift sleepiness in patients receiving Nuvigil compared to the placebo group.
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Nuvigil is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work disorder (SWD), or narcolepsy.
The trial evaluated patients experiencing excessive sleepiness associated with shift work disorder, specifically during the end of their night shifts (i.e., 4:00 a.m. to 8:00 a.m.), including the commute home.
The result of the trial suggested that the patients receiving Nuvigil showed a 9.5 point improvement over baseline in the GAF versus a 5.2 point improvement in the placebo group.
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