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Nuvigil

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Nuvigil

Indications
Dosage
How Supplied

INDICATIONS

NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).

In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment 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 for excessive sleepiness. 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 (OSA) and Narcolepsy

The recommended dose of NUVIGIL for patients with OSA or narcolepsy is 150 mg to 250 mg given once daily 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 these doses confer additional benefit beyond that of the 150 mg/day dose [see CLINICAL PHARMACOLOGY and Clinical Studies].

Shift Work 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. [see Clinical Studies]

Hepatic Impairment

The dose of NUVIGIL should be reduced in patients with severe hepatic impairment, with or without cirrhosis. [see CLINICAL PHARMACOLOGY]

Use in Geriatric Patients

Consideration should be given to the use of lower doses and close monitoring in geriatric patients. [see Use In Specific Populations]

HOW SUPPLIED

Dosage Forms And Strengths

  • 50 mg - round, white to off-white tablet with EH on one side and “205” on the other
  • 150 mg - oval, white to off-white tablet with HD on one side and “215” on the other
  • 200 mg - rounded, rectangular, white to off-white tablet with CU on one side and “220” on the other
  • 250 mg - oval, white to off-white tablet with HD on one side and “225” on the other

Storage And Handling

NUVIGIL® (armodafinil) Tablets are available as follows:

50 mg: Each round, white to off-white tablet is debossed with on one side and “205” on the other.

NDC 63459-205-30 - Bottles of 30

150 mg: Each oval, white to off-white tablet is debossed with na on one side and “215” on the other.

NDC 63459-215-30 - Bottles of 30

200 mg: Each rounded, rectangular, white to off-white tablet is debossed with on one side and “220” on the other.

NDC 63459-220-30 - Bottles of 30

250 mg: Each oval, white to off-white tablet is debossed with HE on one side and “225” on the other.

NDC 63459-225-30 - Bottles of 30

Storage

Store at 20°- 25°C (68°- 77°F).

Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised June 2013

Last reviewed on RxList: 7/30/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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