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Retired

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In response to a query about this medication, it is manufactured by Cephalon, from whose website this information is taken.

PROVIGIL (modafinil) is only for excessive sleepiness associated with certain sleep disorders such as narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. Talk to your doctor to see if PROVIGIL is right for you.


Prescribing Informtion and U.S. Product Monograph

Summary

PROVIGIL?More awake may mean
more engaged

When patients struggle to be adequately awake and functional
PROVIGIL consistently improves wakefulness (1)

Improves ability to sustain attention(2)

Improves ability to participate in daily activities (1-4)

Structurally distinct from amphetamines(1)

Safety demonstrated in clinical studies(1)

No effect on sleep when sleep is desired(1,2,4)
PROVIGIL is indicated to improve wakefulness in patients with excessive sleepiness (ES) associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD).

In OSAHS, PROVIGIL 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 PROVIGIL. If PROVIGIL is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In clinical trials, PROVIGIL was generally well tolerated. The most frequently reported adverse events (=5%) were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.

References:

PROVIGIL full Prescribing Information. Data on file, Cephalon, Inc.

Pack AI, Black JE, Schwartz JRL, Matheson JK, for the U.S. Modafinil in Obstructive Sleep Apnea Study Group. Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea. Am J Respir Crit Care Med. 2001;164:1675-1681.

Black JE, Hirshkowitz M. Modafinil for treatment of residual excessive sleepiness in nasal continuous positive airway pressure-treated obstructive sleep apnea/hypopnea syndrome. Sleep. 2005;287:464-471.
 
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