What was the evidence for FDA approval of modafinil for residual sleepiness in obstructive sleep apnea (OSA)?

Updated: Sep 15, 2020
  • Author: Himanshu Wickramasinghe, MD, MBBS; Chief Editor: Zab Mosenifar, MD, FACP, FCCP  more...
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Answer

FDA approval of modafinil was based on several studies carried out in this patient population. [213, 214, 215] The largest of these studies was a double-blind, randomized, placebo-controlled study in which subjects received either placebo or modafinil (200 mg/d in week 1, 400 mg/d in weeks 2-4) for 4 weeks. [214] . Subjects had an AHI of 15 or more, ESS of 10 or more, and CPAP use of 4 hours per night or more or 5-7 nights or more during 3 weeks of home monitoring.


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