Indications
To improve wakefulness in patients with excessive daytime drowsiness due to narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work disorder.
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.
TIME/ACTION PROFILE (blood levels)
ROUTE
ONSET
PEAK
DURATION
PO
unknown
2 hr
unknown
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 recommended);
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.
Adverse Reactions/Side Effects*
*CAPITALS indicate life threatening; underlines indicate most frequent.
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 (dosage adjustment may be necessary, midazolam and triazolam (excess sedation may occur, dose reduction may be necessary).
Armodafinil also inhibits the CYP2C19 system and may ↑ effects of phenytoin , diazepam, propranolol, omeprazole, and clomipramine (dose reduction and monitoring for toxicity recommended).
Use cautiously with MAO inhibitors and other CNS stimulants.
Route/Dosage
Obstructive Sleep Apnea/Hypopnea Syndrome and Narcolepsy PO (Adults):Obstructive Sleep Apnea/Hypopnea Syndrome and Narcolepsy—150 mg or 150 mg once daily in the morning; shift work sleep disorder—150 mg once daily one hour before start of work.
Availability Tablets: 50 mg , 150 mg, 250 mg.
NURSING IMPLICATIONS
Assessment
Observe and document wakefulness and frequency of narcoleptic episodes.
If concurrent CPAP is used, assess CPAP compliance periodically during therapy.
Monitor blood pressure periodically during therapy.
Potential Nursing Diagnoses Disturbed thought process (Indications). Deficient knowledge, related to disease process and medication regimen (Patient/Family Teaching).
Implementation
PO: Administer as a single dose in the morning
If used for shift work disorder, take daily dose 1 hr prior to start of work shift.
Patient/Family Teaching
Instruct patient to take medication as directed. Advise patients that level of wakefulness may not return to normal. If used as an adjunct to CPAP, encourage patient to continue to use CPAP and other modalities. Inform patient that armodafinil does not take the place of getting enough sleep. Instruct patient to read Patient Information Leaflet prior to therapy.
Medication may impair judgment. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Instruct patient to notify health care professional immediately if rash, hives, mouth sores, blisters, peeling skin, swelling of face, eyes, lips, tongue, or throat, trouble swallowing or breathing, hoarse voice, or other allergic reactions occur. Patients should also notify health care professional if depression, anxiety, hallucinations, mania, thoughts of suicide or other mental problems, or heart problems, including chest pain, occur.
Advise patient that sharing this medication with others, even those with the same symptoms, is dangerous and illegal.
Nonhormonal methods of contraception should be used during and for 1 month following discontinuation of therapy. Instruct patient to notify health care professional promptly if pregnancy is planned or suspected or if breastfeeding.
Instruct patient to avoid taking other prescription or Rx, OTC, or herbal products without consulting health care professional. Advise patient to avoid alcohol use during therapy.
Evaluation/Desired Outcomes
Decrease in narcoleptic symptoms and an enhanced ability to stay awake. Evaluate effects of therapy periodically to determine long term usefulness.