Sorry, your browser does not support JavaScript. Some of the features on this website require Javascript to be enabled.
Print
ShareShare

Share this information with a colleague

Fill out the fields below to send your colleague an email with a direct link to the page you are viewing.

The email they receive will be addressed from you.

By submitting my information, I confirm that I am a healthcare professional and consent to the terms of the Teva Pharmaceuticals Privacy Policy.
   
Please fill out all required fields.
Invalid Email address.

Privacy Statement
Your privacy is important. The information you give us will be used in accordance with our Privacy Policy. View our Privacy Policy.

Your email has been sent.

Thank you for sharing this information with your colleague. He or she will receive an email with a
link to the page you are viewing.

     Or    
IMPORTANT SAFETY INFORMATION
Serious adverse events that may be associated with the use of NUVIGIL® (armodafinil) Tablets [C-IV] include: serious
rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment; angioedema
and hypersensitivity, including fatal multi-organ hypersensitivity reactions; psychiatric adverse experiences; persistent
sleepiness; and cardiovascular adverse reactions.
Read more Important Safety Information

Support your patients with once-daily dosing

Available strengths1

There is no generic equivalent for NUVIGIL available
  • NUVIGIL can be taken with or without food, but food may delay absorption by ≥2 hours1
  • The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after
    discontinuation of therapy1
  • Dose-related adverse events include: headache, rash, depression, dry mouth, insomnia, and nausea.
  • NUVIGIL is a Schedule IV controlled substance because it has the potential to be abused or lead to dependence. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Once-daily dosing recommendation further supported by real-world use2

  • Daily Average Consumption (DACON) is a consideration by managed care plans when making formulary decisions2
  • DACON is the average number of tablets prescribed per day based on prescription fill data2*
  • Calculated tablets dispensed ÷ days supplied2
  • The analysis was not specific to dosage regimen or indication2
*
Based on the number of prescriptions for excessive sleepiness associated with SWD (IMS National Prescription Audit, analysis period June
2009-October 2014). All rights reserved by IMS.

IMPORTANT SAFETY INFORMATION

Contraindications: NUVIGIL is contraindicated in patients with a known hypersensitivity to modafinil or armodafinil or its inactive ingredients.

Serious rash: Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in association with the use of NUVIGIL or modafinil. There are no factors, including duration of therapy, that are known to predict the risk of occurrence or the severity of rash. Although benign rashes also occur with NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious. NUVIGIL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related.

NUVIGIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.

Angioedema and hypersensitivity reactions: Angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm) were observed in patients with NUVIGIL. Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil. Patients should be advised to discontinue NUVIGIL and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis, or multi-organ hypersensitivity.

Psychiatric symptoms: Psychiatric adverse experiences have been reported in patients treated with NUVIGIL and modafinil. In controlled trials in adults treated with NUVIGIL, psychiatric symptoms resulting in treatment discontinuation included anxiety, agitation, nervousness, irritability, and depression. Postmarketing adverse reactions associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation, and aggression, some resulting in hospitalization. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop.

Persistent sleepiness and CNS effects: Patients should be advised that their level of wakefulness may not return to normal. Although NUVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be frequently reassessed for their degree of sleepiness and functional impairment and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Cardiovascular events: Cardiovascular adverse reactions have been reported in patients treated with modafinil in association with mitral valve prolapse or left ventricular hypertrophy. NUVIGIL is not recommended in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome when previously receiving CNS stimulants. If findings of mitral valve prolapse syndrome occur, consider cardiac evaluation. In clinical studies, a greater proportion of patients on NUVIGIL required new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of heart rate and blood pressure may be appropriate in patients on NUVIGIL. Caution should be exercised when prescribing NUVIGIL to patients with known cardiovascular disease.

Drug interactions: NUVIGIL may interact with drugs that are substrates for CYP3A4/5 or CYP2C19. Dose adjustment of these drugs may be required. The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy.

Common adverse reactions: In clinical trials, the most commonly reported adverse reactions (≥5%) associated with the use of NUVIGIL were headache, nausea, dizziness, and insomnia.

NUVIGIL is a Schedule IV controlled substance because it has the potential to be abused or lead to dependence. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Physicians should be aware and inform their patients of the availability of the Medication Guide for NUVIGIL.

Please see Full Prescribing Information for NUVIGIL.

References:
  1. NUVIGIL [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc; 2015.
  2. Data on file. Teva Pharmaceuticals USA, Inc.