Armodafinil

INTRODUCTION

Indications

To improve wakefulness in patients with excessive daytime drowsiness due to narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work disorder.

Action

Produces CNS stimulation. Therapeutic Effects: Improved wakefulness.

Adverse Reactions/Side Effects

CNS: dizziness, headache, insomnia, anxiety, psychiatric reactions. CV: ↑ blood pressure. GI: nausea, dry mouth. Derm: STEVENS-JOHNSON SYNDROME, rash. Misc: MULTIORGAN HYPERSENSITIVITY, ALLERGIC REACTIONS, INCLUDING ANAPHYLACTOID REACTIONS AND ANGIOEDEMA.

PHYSICAL THERAPY IMPLICATIONS

Examination and Evaluation

• Monitor signs of allergic reactions, including anaphylaxis and angioedema. Signs include pulmonary symptoms (tightness in the throat and chest, wheezing, cough, dyspnea) and skin reactions (rash, pruritus, urticaria, swelling in the face, dermatitis, exfoliation). Be especially alert for skin reactions because certain skin reactions may indicate serious hypersensitivity reactions (Stevens-johnson syndrome). Notify physician or nursing staff immediately if these reactions occur.

• Monitor alertness in patients with narcolepsy; document the frequency and duration of sleeping episodes to help assess the effects of drug therapy.

• Be alert for signs of CNS excitation, including sleep loss, anxiety, and other psychiatric reactions. Report these signs to the physician.

• Assess blood pressure and compare to normal values (See Appendix F). Report a sustained increase in blood pressure (BP) (hypertension).

Patient/Client-Related Instruction

• Instruct patient and family/caregivers to report other troublesome side effects, including severe or prolonged nausea or dry mouth.

Pharmacokinetics

Absorption: Readily absorbed following oral administration.

Distribution: Unknown.

Metabolism and Excretion: Mostly metabolized (partially by the CYP3A4 enzyme system; <10% excreted in urine).

Half-life: 15 hr.

Contraindications/Precautions

Contraindicated in: Hypersensitivity to modafinil or armodafinil.

Use Cautiously in: Concurrent alcohol ingestion; History of drug abuse, especially history of stimulant abuse; Severe hepatic impairment (↓ dose recom mended); Recent MI or unstable angina; Geri: Blood levels may by ↑ due to ↓ clearance (lower dose may be necessary); Pedi: Safety and efficacy not established for children <17 yr.

Interactions

Drug-Drug: Since armodafinil is partially metabolized by the CPY3A4 enzyme system, concurrent use of drugs that induce the CYP3A system, including carbamazepine, phenobarbital, and rifampin, may ↓ levels and effectiveness. Concurrent use of drugs that inhibit the CYP3A system, including ketonazole and erythromycin, may ↑ levels and effectiveness. Armodafinil also induces the CYP3A system and may ↓ effectiveness of hormonal contraceptives (additional or alternative methods recommended), cyclosporine...