armodafinil


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armodafinil

(ar-mo-daf-i-nil) ,

Nuvigil

(trade name)

Classification

Therapeutic: central nervous system stimulants
Pregnancy Category: C

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.

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)

ROUTEONSETPEAKDURATION
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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; 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)
  • aggression
  • anxiety
  • delusions
  • hallucinations
  • mania

Cardiovascular

  • ↑ BP

Gastrointestinal

  • nausea (most frequent)
  • dry mouth

Dermatologic

  • Stevens-Johnson SYndrome (life-threatening)
  • rash

Miscellaneous

  • multi-organ hypersensitivity (life-threatening)
  • allergic reactions including anaphylactoid reactions and angioedema (life-threatening)

Interactions

Drug-Drug interaction

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 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.

Route/Dosage

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

Nursing implications

Nursing assessment

  • 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 Diagnoses

Disturbed thought process (Indications)
Deficient knowledge, related to disease process and medication regimen (Patient/Family Teaching)

Implementation

  • 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.

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.
  • 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.

Evaluation/Desired Outcomes

  • Decrease in narcoleptic symptoms and an enhanced ability to stay awake. Evaluate effects of therapy periodically to determine long term usefulness.
Mentioned in ?
References in periodicals archive ?
Armodafinil (Nuvigil) used to treat excessive sleepiness associated with narcolepsy and other sleep disorders is being studied in the Nuvigil Pregnancy Registry (866-404-4106 / www.
Limited Tenders are invited for Supply of Medicine, Acamprosate calcium 333mg, Acarbose 50 mg, Acebrophylline, Alfuzosin 10 mg, Amantadine, Amitriptylline, Aplaphaketoanlogur, Armodafinil, Atenolol, Atorvastatin, B Complex with Zinc, etc.
In addition, you will find news articles about lurasidone, the most recent drug approved for treating bipolar depression, and armodafinil, a sleep drug that is showing efficacy for the depressive component of this vexing disorder.
In addition to showing useful efficacy compared with placebo as adjunctive treatment, armodafinil also had a "very, very benign" adverse effect profile--its 6% dropout rate because of adverse effects was not statistically significant from the 4% rate in placebo patients.
LPI) has received tentative approval for its Armodafinil Tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths as well as another tentative approval for its Doxycycline Capsules, 40 mg (30 mg Immediate-release and 10 mg Delayed-release) from the United States Food and Drugs Administration (FDA).
Statistical superiority to the active comparator 250 mg armodafinil was also found at higher VYVANSE doses.
Armodafinil, the R-enantiomer ofmodafinil, appears equally effective in improving residual sleepiness in CPAP-treated OSA and has a much longer half-life (10-15 h), yet does not appear to interfere with nighttime sleep (98).
Therapeutic use: Armodafinil (6) is the R-enantiomer of modafinil and acts as a central nervous system stimulant.
The 52nd edition features entries for new drugs including Aliskiren, Ambrisentan, Armodafinil, Eculizumab, Lapatinib, Levocetirizine, Retapamulin, and Temsirolimus.
today announced top-line results of its Phase III clinical program for armodafinil (NUVIGIL([R])) as adjunct therapy in adults with major depression associated with bipolar 1 disorder.
BARCELONA - Armodafinil, a drug with Food and Drug Administration approval to treat excessive sleepiness and narcolepsy, showed efficacy for improving concentration, energy, and appetite in a controlled study of nearly 400 patients with bipolar I depression.
The two drugs most beneficial as adjunctive therapy for these patients are modafinil (Provigil) and armodafinil (Nuvigil).