🏅 FDA Orphan Designation

Provigil

Modafinil

Manufacturer: Cephalon, Inc.

Indicated for:

Idiopathic hypersomniaOrphanOBSOLETE: Primary pigmented nodular adrenocortical diseaseNijmegen breakage syndrome-like disorder

FDA-Approved Indications (3)

Idiopathic hypersomniaOrphan Designation

Improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

OBSOLETE: Primary pigmented nodular adrenocortical disease

indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA)

Population: adults

Nijmegen breakage syndrome-like disorder

indicated to improve wakefulness in adult patients with excessive sleepiness associated with shift work disorder (SWD)

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, PROVIGIL 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 and during treatment with PROVIGIL for excessive sleepiness. PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). ( 1 ) Limitations of Use In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

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Provigil

Cephalon, Inc.

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.