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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
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].
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
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.
Additional Nuvigil Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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