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.
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.
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.
Store at 68° to 77°F.
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.
None well documented.
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%).
Increased gamma-glutamyltransferase (1%).
Influenza-like illness, pain, seasonal allergy (1%).
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.
Reduce dose in patients with severe hepatic function impairment.
Psychotic episodes have been reported.
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.
Because of psychoactive and euphoric effects, armodafinil has potential for abuse.
Wakefulness may not return to normal.
Life-threatening rash, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms may occur.
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