FDA label
What is armodafinil used for?
The FDA-approved uses of armodafinil, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Armodafinil tablets are 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, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment ...”
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Armodafinil, tablet
Indications and Usage, quoted from the label by Aurobindo Pharma Limited (ANDA206069). Cross-references to other label sections are left out.
Armodafinil tablets are 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, armodafinil tablets are 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 armodafinil tablets for excessive sleepiness.
Source: DailyMed label, set id 23da56b8-7552-4362-a1ab-e794c131194c, version 6, effective February 2, 2024. NDC 65862-805, one of 18 listings for this product.
Questions
What is armodafinil used for?
The FDA label says: “Armodafinil tablets are 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, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment ...”
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
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