Pregnancy Category: C
ClassificationTherapeutic: central nervous system stimulants
To improve wakefulness in patients with excessive daytime drowsiness due to narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work disorder.
Produces CNS stimulation.
Absorption: Readily absorbed following oral administration.
Metabolism and Excretion: Mostly metabolized (partially by the CYP3A4 enzyme system; <10% excreted in urine).
Half-life: 15 hr.
Time/action profile (blood levels)
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; Geriatric: Blood levels may by ↑ due to ↓ clearance (lower dose may be necessary); Obstetric / Lactation / Pediatric: Safety not established.
Adverse Reactions/Side Effects
Central nervous system
- suicidal ideation (life-threatening)
- dizziness (most frequent)
- headache (most frequent)
- insomnia (most frequent)
- ↑ BP
- nausea (most frequent)
- dry mouth
- Stevens-Johnson SYndrome (life-threatening)
- multi-organ hypersensitivity (life-threatening)
- allergic reactions including anaphylactoid reactions and angioedema (life-threatening)
Drug-Drug interactionSince 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 ketoconazole and erythromycin may ↑ levels and effectiveness.Armodafinil also induces the CYP3A system and may ↓ effectiveness of hormonal contraceptives (additional or alternative methods recommended, cyclosporine (dose adjustment may be necessary, midazolam and triazolam (excess sedation may occur, dose ↓ may be necessary).Armodafinil also inhibits the CYP2C19 system and may ↑ effects of phenytoin, diazepam, propranolol, omeprazole, and clomipramine (dose ↓ and monitoring for toxicity recommended).Use cautiously with MAO inhibitors and other CNS stimulants.
Oral (Adults) Obstructive sleep apnea/hypopnea syndrome and narcolepsy—150–250 mg once daily in the morning; Shift work sleep disorder—150 mg once daily one hour before start of work.
Availability (generic available)
Tablets: 50 mg, 150 mg, 250 mg
- Observe and document wakefulness and frequency of narcoleptic episodes.
- If concurrent CPAP is used, assess CPAP adherence periodically during therapy.
- Assess for psychiatric symptoms (mania, delusions, hallucinations, suicidal ideation, aggression) periodically during therapy; may require discontinuation.
- Monitor BP periodically during therapy.
Potential Nursing DiagnosesDisturbed thought process (Indications)
Deficient knowledge, related to disease process and medication regimen (Patient/Family Teaching)
- Oral: 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.
- 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.
- Advise patient that sharing this medication with others, even those with the same symptoms, is dangerous and illegal.
- 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 (mania, delusions, hallucinations, suicidal ideation, aggression), or heart problems, including chest pain, occur.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Advise patient to avoid alcohol use during therapy.
- Advise patient to use nonhormonal methods of contraception during and for 1 mo following discontinuation of therapy. Instruct patient to notify health care professional promptly if pregnancy is planned or suspected or if breastfeeding.
- Decrease in narcoleptic symptoms and an enhanced ability to stay awake. Evaluate effects of therapy periodically to determine long term usefulness.
Drug Guide, © 2015 Farlex and Partners