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NUVIGIL (ARMODAFINIL) TABLETS: SPECIAL PRECAUTIONS

Diagnosis of Sleep Disorders

Nuvigil (Armodafinil) should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of either narcolepsy, OSA, and/or SWD has been made in accordance with ICSD or DSM diagnostic criteria. Such an evaluation usually consists of a complete history and physical examination, and it may be supplemented with testing in a laboratory setting. Some patients may have more than one sleep disorder contributing to their excessive sleepiness (e.g., OSA and SWD coincident in the same patient).

CPAP Use in Patients with OSA

In OSA, Nuvigil is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Armodafinil (Nuvigil). If this medication is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. There was a slight trend for reduced CPAP use over time (mean reduction of 18 minutes for patients treated with Nuvigil and a 6 minute reduction for placebo-treated patients from a mean baseline use of 6.9 hours per night) in Nuvigil (Armodafinil) tablets trials.

Alcohol

Patients should be advised that the use of Nuvigil in combination with alcohol has not been studied. Patients should be advised that it is prudent to avoid alcohol while taking Armodafinil (Nuvigil).

Allergic Reactions

Patients should be advised to stop taking Nuvigil (Armodafinil) tablets and to notify their physician if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing or a related allergic phenomenon.

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