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NUVIGIL (ARMODAFINIL) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Nuvigil (Armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35.

Armodafinil is a white to off-white, crystalline powder that is very slightly soluble in water, sparingly soluble in acetone and soluble in methanol. Nuvigil tablets contain 50, 150 or 250 mg of armodafinil and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, magnesium stearate, povidone, microcrystalline cellulose, pregelatinized starch.


CLINICAL PHARMACOLOGY

Nuvigil clinical pharmacology


PHARMACOKINETICS

Nuvigil pharmacokinetics


PHARMACOKINETICS FOR DRUG-DRUG INTERACTIONS

Nuvigil pharmacokinetics for drug-drug interactions


PHARMACOKINETICS FOR SPECIAL POPULATIONS

Nuvigil pharmacokinetics for special populations


CLINICAL TRIALS

The effectiveness of Nuvigil (Armodafinil) tablets in improving wakefulness has been established in the following sleep disorders: obstructive sleep apnea (OSA), narcolepsy and shift work disorder (SWD).

For each clinical trial, a p-value of <= 0.05 was required for statistical significance.


CLINICAL TRIALS FOR OBSTRUCTIVE SLEEP APNEA (OSA)

Nuvigil clinical trials for obstructive sleep apnea (OSA)


CLINICAL TRIALS FOR NARCOLEPSY

Nuvigil clinical trials for narcolepsy


CLINICAL TRIALS FOR SHIFT WORK DISORDER (SWD)

Nuvigil clinical trials for shift work disorder (SWD)


INDICATIONS AND USAGE

Nuvigil indications and usage


CONTRAINDICATIONS

Nuvigil is contraindicated in patients with known hypersensitivity to modafinil and armodafinil or its inactive ingredients.


WARNINGS

Nuvigil warnings


SPECIAL WARNINGS

Nuvigil special warnings


PRECAUTIONS

Nuvigil precautions


SPECIAL PRECAUTIONS

Nuvigil special precautions


PRECAUTIONS FOR SPECIAL POPULATIONS

Nuvigil precautions for special populations


DRUG INTERACTIONS

Nuvigil drug interactions


NONCLINICAL TOXICOLOGY

Nuvigil nonclinical toxicology


USE IN SPECIAL POPULATIONS

Nuvigil use in special populations


ADVERSE REACTIONS

Nuvigil adverse reactions


DRUG ABUSE AND DEPENDENCE

Nuvigil drug abuse and dependence


OVERDOSAGE

Nuvigil overdosage


DOSAGE AND ADMINISTRATION

Nuvigil dosage and administration


HOW SUPPLIED

Nuvigilr (Armodafinil) Tablets

50 mg: Each round, white, uncoated tablet is debossed with "C" on one side and "205" on the other. Bottles of 60.

150 mg: Each oval, white, uncoated tablet is debossed with "C" on one side and "215" on the other. Bottles of 60.

250 mg: Each oval, white, uncoated tablet is debossed with "C" on one side and "225" on the other. Bottles of 60.

Storage

Store at 20° - 25°C (68° - 77° F).

Manufactured and distributed by Cephalon, Teva pharmaceutical companies and their divisions.

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