armodafinil
Nuvigil	Pharmaceutical company: Cephalon, Inc. www.cephalon.com

Pharmacologic classification: dopamine reuptake inhibitor
Therapeutic classification: CNS stimulant
Pregnancy risk category: C
Controlled substance schedule: IV

AVAILABLE FORMS
Tablets: 50, 150, 250 mg

INDICATIONS AND DOSAGES
Excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder--
Adults: OSAHS, narcolepsy: 150 to 250 mg/day P.O. once daily in the morning. Shift work sleep disorder: 150 mg/day P.O. once daily 1 hour before start of the work shift.
ADJUST-A-DOSE:
Decrease the dose in patients with severe hepatic impairment and in elderly patients.

CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients with known hypersensitivity to any component of the drug or to modafinil.
   Use cautiously in patients with a history of psychosis, depression, mania, or drug abuse or dependence. Use cautiously in pregnant and breast-feeding women.

INTERACTIONS
Drug-drug. Hormonal contraceptives: May decrease effectiveness of contraceptives during and up to one month after treatment. Recommend the use of barrier contraceptives.
Warfarin and CYP enzyme inducers such as phenytoin, omeprazole, diazepam and propranolol: Armodafinil may increase levels and effects of these drugs. Dosage decrease may be needed. Monitor patient for toxicity.
CYP enzyme inhibitors such as cyclosporine, ethinyl estradiol, midazolam, triazolam: Armodafinil may decrease levels and effectiveness of these drugs. Dosage adjustment may be needed. Monitor for effectiveness of treatment.

ADVERSE REACTIONS
CNS: headache, dizziness, insomnia, disturbance in attention, tremor, paresthesia, anxiety, depression, agitation, nervousness, pyrexia, thirst, migraine.
CV: palpitations.
GI: nausea, diarrhea, dry mouth, dyspepsia, constipation, vomiting, anorexia, upper abdominal pain.
GU: polyuria.
Respiratory: dyspnea.
Skin: hyperhydrosis, rash, dermatitis, Stevens Johnson syndrome.
Other: fatigue, flulike syndrome, dependence.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING.

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