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red-handed letter to modafinil

informed the company Cephalon GmbH in a red-handed letter of February 2011 about the fact that Modafinil (Vigil ®) only for the treatment of adults with excessive sleepiness associated with narcolepsy, with and without catalepsy, associated, are authorized.

A risk evaluation of the Committee for Human Use (CHMP) of the European Medicines Agency (EMA) concluded that the benefit / risk ratio of modafinil is not considered more favorable for the treatment of:

• of moderate to severe obstructive sleep apnea syndrome (OSAS) with excessive sleepiness despite adequate CPAP *- therapy
• of moderate to severe chronic shift worker syndrome with excessive sleepiness in patients with night-shift changes, when other sleep hygiene measures have led to no improvement

This new information not require immediate changes to the treatment, however, the treatment received are reviewed at the next routine visit of the patient.
red-handed letter of 7 February 2011
Source:
Drug Commission of German Pharmacists, 8 February 2011