Nuvigil

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)

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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.

Nuvigil

a trademark for armodafinil.
Mentioned in ?
References in periodicals archive ?
However, they are estimated to lose market share over the forecast period owing to patent expiration of key drugs in this category such as Provigil and Nuvigil.
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.
to settle all outstanding patent litigation related to Actavis' generic version of Nuvigil (armodafinil tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg).
She adds that newer medications such as Provigil and Nuvigil are not stimulant-based and "do a fantastic job of assisting a person with diagnosed narcolepsy to stay awake and alert during the day.
The drug is called Nuvigil from Cephalon, a drug company in Frazer, Pennsylvania (6).
Nuvigil, which wasn't sold in the year-ago period, added $34.
The company's proprietary products in the United States include: AMRIX (cyclobenzaprine hydrochloride extended-release capsules), TREANDA (bendamustine hydrochloride) for Injection, FENTORA (fentanyl buccal tablet) (C-II), PROVIGIL (modafinil) Tablets (C-IV), TRISENOX (arsenic trioxide) injection, GABITRIL (tiagabine hydrochloride), NUVIGIL (armodafinil) Tablets (C-IV) and ACTIQ (oral transmucosal fentanyl citrate) (C-II).
This is why the military, for example, has funded research into new drugs like Provigil and Nuvigil and now orexin A in an effort to help troops stay awake without deleterious side effects.
has received approval from the FDA to market NUVIGIL (armodafinil) Tablets [C- IV], a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder (SWSD).
The novel wakefulness agents Provigil and Nuvigil are believed to act on hypocretin.
262 BRIEF HISTORY 262 PRODUCTS 262 Tempur-Pedic 262 Tempur 262 Sealy Posturepedic 263 Sealy Optimum 263 REVENUE HISTORY 263 TABLE 58 TEMPUR SEALY'S REVENUES, 2009-2013 ($ MILLIONS) 263 TEVA PHARMACEUTICAL INDUSTRIES LIMITED 264 BRIEF HISTORY 264 PRODUCTS 264 Provigil (Modafinil) 264 Nuvigil (Armodafinil) 264 TABLE 59 U.
Lupin ' s Armodafinil Tablets are the AB-rated generic equivalent of Cephalon Inc's Nuvigil tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.