September 4, 2015
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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).

Limitations of Use

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.

DOSAGE AND ADMINISTRATION

Dosage In Obstructive Sleep Apnea (OSA) And Narcolepsy

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

Dosage In Shift Work Disorder (SWD)

The recommended dosage of NUVIGIL for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift.

Dosage Modification In Patients With Severe Hepatic Impairment

In patients with severe hepatic impairment, the dosage of NUVIGIL should be reduced [see Use in Specific Populations and 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 Streng

  • 50 mg – round, white to off-white tablet with C on one side and “205” on the other
  • 150 mg – oval, white to off-white tablet with C on one side and “215” on the other
  • 200 mg – rounded, rectangular, white to off-white tablet with C on one side and “220” on the other
  • 250 mg – oval, white to off-white tablet with 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 C 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 C 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 C 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 C on one side and “225” on the other. NDC 63459-225-30 – Bottles of 30

Storage

Store at 20°- 25o C (68°- 77°F).

Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. Revised April 2015

Last reviewed on RxList: 4/27/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Nuvigil - User Reviews

Nuvigil User Reviews

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