Armodafinil

DEA Class; Rx

Common Brand Names; Nuvigil

CNS stimulant unrelated to amphetamines; the R-enantiomer of modafinil; increases mental alertness and decreases fatigue.
Used in adults for excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift-work sleep disorder.

Indicated to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea (OSA)

Indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy

For the treatment of obstructive sleep apnea to improve wakefulness in patients with excessive sleepiness.

Hypersensitivity to modafinil, armodafinil, or other ingredients

• Headache (14-23%)
• Nausea (6-9%)
• Dry mouth (2-7%)
• Dizziness (5%)
• Anxiety (4%)
• Diarrhea (4%)
• Insomnia (4%)
• Rash (1-4%)
• Depression (1-3%)
• Dyspepsia (2%)
• Fatigue (2%)
• Palpitations (2%)
• Agitation (1%)
• Anorexia (1%)
• Attention disturbances (1%)
• Contact dermatitis (1%)
• Dyspnea (1%)
• Hyperhidrosis (1%)
• Nervousness (1%)
• Paresthesia (1%)
• Pyrexia (1%)
• Angioedema
• Dysphagia
• Bronchospasm
• Reversible psychosis
• Aggression
• Mouth Sores
• Persistent sleepiness

Not recommended in patients with angina, cardiac ischemia, recent history of myocardial infarction, left ventricular hypertrophy, or mitral valve prolapse

Use caution in patients with history of left ventricular hypertrophy/mitral valve prolapse who have had mitral valve prolapse syndrome when previously receiving CNS stimulants; consider increased monitoring

Use caution in severe hepatic impairment and the elderly

History of depression, psychosis, mania; consider discontinuing armodafinil if psychiatric symptoms develop

May reduce effectiveness of steroidal contraceptives 1 month after discontinuation of drug therapy

If used adjunctively with continuous positive airway pressure (CPAP), periodic assessment of CPAP compliance is necessary

Serious rash requiring hospitalization and discontinuation of treatment has been reported; discontinue at first sign of serious rash

Discontinue therapy if symptoms suggest angioedema or anaphylaxis

Skin and mouth sores, blistering, and ulceration reported

Limited available data in pregnant women are insufficient to inform about drug associated risk of adverse pregnancy outcomes; intrauterine growth restriction and spontaneous abortion reported in association with armodafinil and modafinil.

There are no data on presence of armodafinil or metabolite in human milk, effects on breastfed infant, or effect of this drug on milk production; modafinil was present in rat milk when animals were dosed during the lactation period