Nuvigil (Armodafinil) - Indications and Dosage

INDICATIONS AND USAGE

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

In OSAHS, 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.

DOSAGE AND ADMINISTRATION

Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) and Narcolepsy

The recommended dose of NUVIGIL for patients with OSAHS or narcolepsy is 150 mg or 250 mg given as a single dose in the morning. In patients with OSAHS, 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 (SWSD)

The recommended dose of NUVIGIL for patients with SWSD 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).

HOW SUPPLIED:

NUVIGIL™ (armodafinil) Tablets [C-IV]

50 mg: Each round, white to off-white tablet is debossed with

NDC 63459-205-60 - Bottles of 60

100 mg: Each rounded, rectangular, white to off-white tablet is debossed with

NDC 63459-210-60 - Bottles of 60

150 mg: Each oval, white to off-white tablet is debossed with

NDC 63459-215-60 - Bottles of 60

200 mg: Each rounded, rectangular, white to off-white tablet is debossed with

NDC 63459-220-60 - Bottles of 60

250 mg: Each oval, white to off-white tablet is debossed with

NDC 63459-225-60 - Bottles of 60

Store at 20° - 25° C (68° - 77° F). 

Manufactured for:

Cephalon, Inc.

Frazer, PA 19355

U.S. Patent Nos. RE37,516; 4,927,855; 7,132,570; 7,297,346

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

© 2007, 2008 Cephalon, Inc. or its affiliates. All rights reserved.

November 2008

NUV-003

PATIENT INFORMATION

NUVIGIL™ (nu-vij-el) Tablets [C-IV]

Generic name: armodafinil

Read the Patient Information that comes with NUVIGIL before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is the most important information I should know about NUVIGIL?

1. NUVIGIL may cause you to have a serious rash or a serious allergic reaction. Stop NUVIGIL and call your doctor right away or get emergency treatment if you have any of the following:
   skin rash, hives, sores in your mouth, or your skin blisters and peels
   • swelling of your face, eyes, lips, tongue, or throat
   • trouble swallowing or breathing
   • hoarse voice
2. NUVIGIL has not been studied in children under the age of 17. NUVIGIL is not approved for children for any condition.

What is NUVIGIL?

NUVIGIL is a prescription medicine used to improve awakeness in adults who are very sleepy due to one of the following diagnosed sleep problems:

• shift work sleep disorder (SWSD)
• obstructive sleep apnea/hypopnea syndrome (OSAHS). NUVIGIL is used along with other medical treatments for this sleep problem. NUVIGIL is not a replacement for your CPAP machine. It is important that you continue to use your CPAP machine while sleeping.
• narcolepsy

You should be diagnosed with one of these sleep disorders before taking NUVIGIL. Sleepiness can be a symptom of other medical conditions that need to be treated.

• NUVIGIL will not cure the above sleep disorders. NUVIGIL may help the sleepiness caused by these conditions, but it may not stop all your sleepiness.
• NUVIGIL does not take the place of getting enough sleep. 
• Follow your doctor's advice about good sleep habits and using other treatments.