Generic Name

Armodafinil

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Classification

FDA Approved Indications

• Narcolepsy
• Obstructive sleep apnea/hypopnea syndrome
• Shift work sleep disorder

Mechanism of Action

Armodafinil promotes wakefulness primarily by affecting hypothalamic pathways that regulate the sleep-wake cycle, possibly through increasing synaptic concentrations of dopamine by inhibiting dopamine reuptake.

Dosage and Administration

Adult: Typically 150 mg once daily in the morning. Dose adjustments may be made based on response and tolerability.

Pediatric: Not FDA approved for pediatric use; safety and efficacy not established.

Geriatric: Use with caution; start at the lower end of the dosing range due to potential increased sensitivity.

Renal Impairment: Adjust dose cautiously; no specific guidelines, but renal function affects drug clearance.

Hepatic Impairment: Use with caution; no specific guidelines, but hepatic impairment may increase plasma concentrations.

Pharmacokinetics

Absorption: Rapidly absorbed, peak plasma concentrations in approximately 2 hours.

Distribution: Widely distributed; protein binding approximately 60%.

Metabolism: Metabolized mainly by hydrolysis and N-acetylation; CYP3A4 involved partially.

Excretion: Excreted primarily in urine (around 60%), with the remainder in feces.

Half Life: Approximately 12-15 hours.

Contraindications

• Hypersensitivity to armodafinil or modafinil.
• History of hypersensitivity reactions.

Precautions

• Use with caution in patients with a history of psychiatric disorders, cardiovascular disease, or drug abuse.
• Potential for severe skin reactions (e.g., Stevens-Johnson syndrome).
• Monitor for neuropsychiatric symptoms, such as anxiety, hallucinations, or agitation.

Adverse Reactions - Common

• Headache (Common)
• Nausea (Common)
• Dizziness (Common)
• Insomnia (Common)

Adverse Reactions - Serious

• Serious skin reactions (e.g., Stevens-Johnson syndrome) (Rare)
• Cardiovascular events (e.g., hypertension, tachycardia) (Rare)
• Psychiatric symptoms (e.g., anxiety, hallucinations) (Rare)

Drug-Drug Interactions

• Contraceptives (may reduce effectiveness)
• Other CNS stimulants or depressants

Drug-Food Interactions

• Possible altered absorption with high-fat meals

Drug-Herb Interactions

• Potential interactions with St. John's Wort and other CYP3A4 inducers/inhibitors

Nursing Implications

Patient/Family Teaching

• Take medication exactly as prescribed.
• Report any skin rashes or allergic reactions immediately.
• Avoid alcohol and other CNS depressants.
• Be aware of potential side effects like headache and insomnia.

Special Considerations

Black Box Warnings:

• Potential for severe skin reactions and hypersensitivity.
• Risk of serious dermatologic reactions.

Genetic Factors: Limited data, but genetic variability may affect metabolism and response.

Lab Test Interference: May interfere with urine drug screens for stimulants.

Overdose Management

Signs/Symptoms: Agitation, headache, confusion, hallucinations, tachycardia, hypertension.

Treatment: Supportive care; control of symptoms; activated charcoal if ingestion recent; dialysis not effective due to high protein binding.

Storage and Handling

Storage: Store at room temperature (20-25°C), away from moisture and light.

Stability: Stable under recommended storage conditions.