ARMODAFINIL

Other

Brand names: Armodafinil

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism(s) through which armodafinil promotes wakefulness is unknown. Armodafinil (R-modafinil) has pharmacological properties similar to those of modafinil (a mixture of R- and S-modafinil), to the extent tested in animal and in vitro studies. The R- and S-enantiomers have similar pharmacological actions in animals. Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines. Modafinil-induced wakefulness can be attenuated by the α 1 -adrenergic receptor antagonist, prazosin; however, modafinil is inactive in other in vitro assay systems known to be responsive to α-adrenergic agonists such as the rat vas deferens preparation. Armodafinil is an indirect dopamine receptor agonist; both armodafinil and modafinil bind in vitro to the dopamine transporter and inhibit dopamine reuptake. For modafini

Indications

1 INDICATIONS AND USAGE 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

narcolepsy

or shift work disorder (SWD). ( 1 ) Limitations of Use In OSA

armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

Contraindications

• 4 CONTRAINDICATIONS Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see Warnings and Precautions (5.1
• 5.2
• 5.3) ] . Armodafinil tablets are contraindicated in patients with known hypersensitivity to modafinil or armodafinil.

FDA Warnings

5 WARNINGS AND PRECAUTIONS Serious Rash, including Stevens-Johnson Syndrome: discontinue armodafinil at the first sign of rash, unless the rash is clearly not drug-related
1 Serious Dermatologic Reactions, including Stevens-Johnson Syndrome and Toxic Epidermal Necrosis Serious rash requiring hospitalization and discontinuation of treatment has been reported in association with the use of armodafinil or modafinil (the racemic mixture of S- and R-enantiomers)
8% (13 per 1,585) in pediatric patients (age <17 years); these rashes included 1 case of possible Stevens-Johnson syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction/ Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5
Recurrence of signs and symptoms of serious dermatologic reactions following rechallenge has been reported in some cases

Known Side Effects

12 documented side effects by frequency

Drug Not Working

1-10%

Fatigue

1-10%

Nausea

1-10%

Headache

1-10%

Anxiety

1-10%

Drowsiness

1-10%

Depression

1-10%

Insomnia

1-10%

Falls

1-10%

Dizziness

1-10%

Weight Loss

0.1-1%

Condition Worsened

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral