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Nuvigil (Armodafinil) - Indications and Dosage



NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea, narcolepsy and shift work disorder.

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 NUVIGIL. If NUVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.

In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

The effectiveness of NUVIGIL in long-term use (greater than 12 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe NUVIGIL for an extended time in patients should periodically re-evaluate long-term usefulness for the individual patient.


Obstructive Sleep Apnea (OSA) and Narcolepsy

The recommended dose of 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 (See CLINICAL PHARMACOLOGY and CLINICAL TRIALS).

Shift Work Sleep Disorder (SWD)

The recommended dose of NUVIGIL 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 (See PRECAUTIONS, Drug Interactions).

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 (See PRECAUTIONS, Drug Interactions).

In patients with severe hepatic impairment, NUVIGIL should be administered at a reduced dose (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment (See CLINICAL PHARMACOLOGY and PRECAUTIONS).

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 (See CLINICAL PHARMACOLOGY and PRECAUTIONS).


NUVIGIL® (armodafinil) Tablets [C-IV]

150 mg:Each oval, white uncoated tablet is debossed with "C" on one side and "215" on the other.

NDC 16590-345-30 - Bottles of 30

250 mg: Each oval, white uncoated tablet is debossed with "C" on one side and "225" on the other.

NDC 16590-394-30 - Bottles of 30

Store at 20° - 25° C (68° - 77° F).

Distributed by:

Cephalon, Inc.

Frazer, PA 19355

U.S. Patent Nos. RE37,516; 7,132,570; 7,297,346

NUVIGIL is a trademark of Cephalon, Inc. or its affiliates.

© 2007-2010 Cephalon, Inc. All rights reserved.

October 2010


Relabeling and Repackaging by:
Gainesville, GA 30501

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