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Drugs reference index «Armodafinil»


Pronunciation: (ar-moe-DAF-in-il)Class: Analeptic

Trade Names:Nuvigil- Tablets 50 mg- Tablets 150 mg- Tablets 250 mg


Wakefulness-promoting agent; however, the precise mechanism is unknown.



Readily absorbed after oral administration. C max approximately 2 h. Food delays T max approximately 2 to 4 h. Steady state is reached within 7 days of dosing.


Vd is approximately 42 L. Binding to plasma protein, primarily albumin, is 60%.


Undergoes hydrolytic deamidation (with sulfone formation by CYP3A4/5), S-oxidation, and aromatic ring hydroxylation, with subsequent glucuronide conjugation of the hydroxylated products.


Terminal t ½ is approximately 15 h. Oral CrCl is approximately 33 mL/min. Mainly eliminated by hepatic metabolism with less than 10% excreted in the urine.

Indications and Usage

Improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome, narcolepsy, and shift work sleep disorder.


Hypersensitivity to modafinil or armodafinil or any component of the product.

Dosage and Administration

Obstructive Sleep Apnea/Hypopnea Syndrome and NarcolepsyAdults and Children older than 16 yr of age

PO 150 or 250 mg as a single dose in the morning.

Shift Work Sleep DisorderAdults and Children older than 16 yr of age

PO 150 mg daily approximately 1 h prior to the start of work shift.

General Advice

  • Consider dosage adjustments for drugs that are substrates for CYP3A4/5.


Store at 68° to 77°F.

Drug Interactions

Drugs metabolized by CYP2C19 (eg, diazepam, omeprazole, phenytoin, propranolol)

Plasma concentration may be elevated by armodafinil, increasing the risk of adverse reactions. Dosage reduction of these agents may be necessary.

Drugs metabolized by CYP3A4/5 (eg, cyclosporine, ethinyl estradiol, midazolam, triazolam)

Plasma concentrations may be reduced by armodafinil, decreasing efficacy.

Potent inducers of CYP3A4/5 (eg, carbamazepine, phenobarbital, rifampin)

Armodafinil concentrations may be reduced, decreasing efficacy.

Potent inhibitors of CYP3A4/5 (eg, erythromycin, ketoconazole)

Armodafinil concentrations may be elevated, increasing the risk of adverse reactions.

Laboratory Test Interactions

None well documented.

Adverse Reactions


Palpitations (2%); increased heart rate (1%).


Headache (23%); insomnia (6%); dizziness (5%); anxiety (4%); depression (3%); fatigue (2%); agitation, attention disturbance, decreased appetite, depressed mood, migraine, nervousness, paresthesia, pyrexia, thirst, tremor (1%).


Rash (4%); contact dermatitis, hyperhidrosis (1%).


Nausea (9%); dry mouth (7%); diarrhea (4%); dyspepsia, upper abdominal pain (2%); anorexia, constipation, loose stools, vomiting (1%).

Lab Tests

Increased gamma-glutamyltransferase (1%).


Dyspnea (1%).


Influenza-like illness, pain, seasonal allergy (1%).



Monitor BP.


Category C .




Safety and efficacy not established in patients younger than 17 yr of age.


Consider using lower doses in elderly patients because of possible reduced drug elimination.


Rare cases of angioedema, anaphylactoid reactions, and multiorgan hypersensitivity have been reported.

Hepatic Function

Reduce dose in patients with severe hepatic function impairment.


Psychotic episodes have been reported.

CV system

Use with caution in patients with recent history of MI or unstable angina. Avoid use in patients with history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome with previously administered CNS stimulants.

Drug abuse

Because of psychoactive and euphoric effects, armodafinil has potential for abuse.

Persistent sleepiness

Wakefulness may not return to normal.

Severe rash

Life-threatening rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms may occur.

Patient Information

  • Advise patient to read the patient information leaflet before using product the first time and with each refill.
  • Advise patients that the drug affects the CNS and may impair judgment or thinking skill, and to use caution while driving, riding a bike, or performing other tasks until they are certain that therapy will not adversely affect their ability to engage in such activities.
  • Advise patients that drug may improve, but not eliminate, abnormal tendency to fall asleep.
  • Inform patients to take their previously prescribed treatments.
  • Advise patients to notify health care provider if they experience anxiety, chest pain, depression, or signs of psychosis or mania.
  • Advise patients to notify health care provider if they develop blisters, hives, mouth sores, peeling skin, rash, trouble swallowing or breathing, or a related allergic phenomenon.
  • Advise women who become pregnant or intend to become pregnant during therapy to notify health care provider.
  • Advise women who are breast-feeding to notify health care provider.
  • Advise patients to avoid alcohol while taking this medication.

Copyright © 2009 Wolters Kluwer Health.

  • Armodafinil MedFacts Consumer Leaflet (Wolters Kluwer)
  • armodafinil Advanced Consumer (Micromedex) - Includes Dosage Information
  • Nuvigil Prescribing Information (FDA)
  • Nuvigil Consumer Overview

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