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NUVIGIL (ARMODAFINIL) TABLETS: DOSAGE AND ADMINISTRATION

Obstructive Sleep Apnea (OSA) and Narcolepsy

The recommended dose of Armodafinil (Nuvigil) for patients with OSA or narcolepsy is 150 mg or 250 mg given as a single dose in the morning. In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit beyond that of the 150 mg/day dose.

Shift Work Disorder (SWD)

The recommended dose of Nuvigil (Armodafinil) tablets for patients with SWD is 150 mg given daily approximately 1 hour prior to the start of their work shift.

Dosage adjustment should be considered for concomitant medications that are substrates for CYP3A4/5, such as steroidal contraceptives, triazolam, and cyclosporine.

Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with Nuvigil and may require dosage reduction and monitoring for toxicity.

In patients with severe hepatic impairment, Armodafinil (Nuvigil) tablets should be administered at a reduced dose.

There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.

In elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population.

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