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Could You Be at Risk for Excessive Sleepiness (ES) Due to Shift Work Disorder (SWD)?

3.75 million Americans are at risk for shift work disorder (SWD).1-4

  • Do you work shifts or a non-traditional work schedule?
  • Do you feel tired or sleepy when you need to be awake?
Learn if you could be suffering from excessive sleepiness (ES) due to shift work disorder (SWD).
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While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with ES due to SWD, they are not used to treat SWD itself or its other symptoms or consequences.

Could You Be at Risk for Excessive Sleepiness (ES) Due to Shift Work Disorder (SWD)?

Your doctor may consider the criteria below to determine whether you have SWD:5

  • Irregular sleep patterns leading to ES or insomnia
  • Irregular sleep patterns affecting your work or personal life
  • Irregular sleep patterns not caused by any other sleep or medical condition
  • Irregular sleep patterns not caused by a medication or substance

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with ES due to SWD, they are not used to treat SWD itself or its other symptoms or consequences.

A Wide Range of Occupations Require Permanent or Occasional Shift Work1

  • Professional and business services such as accountants, stockbrokers, customer service reps, IT support staff, and other people with corporate jobs
  • Healthcare professionals such as emergency room physicians, nurses, and overnight pharmacists
  • Leisure, entertainment, and hospitality such as bartenders, servers, chefs, casino dealers, performers, radio DJs, concierges, and doormen
  • Wholesale and retail trade such as warehouse workers, department store and other retail store workers
  • Production and manufacturing such as steel, textile, and other factory workers
  • Protective services such as firefighters, dispatchers, and security guards

What Is Shift Work Disorder (SWD)?

SWD Is a Medical Condition That Can Be Diagnosed and Treated by a Doctor

SWD occurs when your body's internal sleep-wake clock is out of sync with your work schedule — your body is telling you to go to sleep when your work schedule needs you to stay awake. Because of this disruption of your body's natural rhythm, people with SWD often struggle to stay awake during their waking hours, or have trouble sleeping during their sleeping hours.

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with ES due to SWD, they are not used to treat SWD itself or its other symptoms or consequences.

Why Is It Important to See a Doctor about Shift Work Disorder?

SWD can lead to other issues:6

  • Trouble focusing
  • Sleepiness-related accidents
  • Reduced work performance
  • Missed family and social activities
  • Increased irritability
  • Worsening of heart and stomach disorders

While NUVIGIL® (armodafinil) Tablets [C-IV] are used to improve wakefulness in patients with ES due to SWD, they are not used to treat SWD itself or its other symptoms or consequences.

Excessive Sleepiness in Shift Workers4

  • Up to 45% of night‑shift workers experience ES.
  • Up to 36% of rotating‑shift workers experience ES.

Many of these shift workers with excessive sleepiness may suffer from SWD.2,6

NUVIGIL has been shown to improve wakefulness throughout the shift for people suffering from ES due to SWD.

  • While NUVIGIL® is used to improve wakefulness in patients with ES due to SWD, it is not used to treat SWD itself or its other symptoms or consequences.
  • Talk to your doctor about whether you should avoid driving or using heavy machinery while taking NUVIGIL.
Try NUVIGIL FREE

NUVIGIL Could Improve Your Wakefulness throughout the Shift7

NUVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to shift work disorder (SWD).

  • NUVIGIL was studied in a 12-week clinical trial of patients with shift work disorder
  • This clinical trial included 254 patients

People who took NUVIGIL experienced significant improvement in wakefulness throughout the shift compared to patients taking placebo.7

The MSLT is a measure of a person's degree of sleepiness. The measures were averaged between 2 am and 8 am during simulated night shifts.8-10

NUVIGIL could help you throughout your shift with improved wakefulness.

More than 800,000 prescriptions for NUVIGIL® have been written since 20099

NUVIGIL may cause you to have a serious rash or a serious allergic reaction that may result in hospitalization or be life-threatening.

If you develop a rash, hives, sores, swelling, or trouble swallowing or breathing, stop taking NUVIGIL and call your doctor right away or get emergency treatment.

NUVIGIL has not been studied in children under the age of 17. NUVIGIL is not approved for children for any condition.

In clinical studies, most reported side effects were rated as mild to moderate. Common side effects of NUVIGIL were headache, nausea, dizziness, and trouble sleeping.

NUVIGIL is a federally controlled substance [C-IV] because it has the potential to be abused or lead to dependence. Please use NUVIGIL only as directed and keep in a safe place to prevent misuse and abuse.

Talk to your doctor about whether you should avoid driving or using heavy machinery while taking NUVIGIL.

Try NUVIGIL FREE

How Can You Prepare Yourself to Speak with Your Doctor?

The time you have face-to-face conversations with your doctor is often limited, so knowing what information to give him or her about your shift work disorder symptoms may help.

Let your doctor know about:

  • When and where you feel sleepy
  • How ES affects your job or personal life
  • If you plan your life around sleepiness
  • What hours you typically work
  • If you feel that your ES is interfering with your job routine
  • If you have had any changes in your work schedule
  • Things you do to stay awake (like drinking coffee, soda, or energy drinks)
  • Your work schedule

While NUVIGIL® is used to improve wakefulness in patients with ES due to
SWD, it is not used to treat SWD itself or its other symptoms or consequences.

Try NUVIGIL FREE

Try NUVIGIL FREE

Try NUVIGIL FREE

Important Safety Information

What is NUVIGIL?

NUVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder, or narcolepsy.

In patients with OSA, NUVIGIL is used along with other medical treatments for this sleep disorder. NUVIGIL is not a replacement for your current treatment. Consult your doctor about the importance of continuing your current OSA treatment while taking NUVIGIL.

NUVIGIL is a federally controlled substance (C-IV) because it has the potential to be abused or lead to dependence. Please use NUVIGIL only as directed and keep in a safe place to prevent misuse and abuse.

What important information should I know about NUVIGIL?

  • NUVIGIL may cause you to have a serious rash or a serious allergic reaction that may result in hospitalization or be life-threatening.
  • If you develop a rash, hives, sores, swelling, or trouble swallowing or breathing, stop taking NUVIGIL and call your doctor right away or get emergency treatment.

Who should not take NUVIGIL?

  • NUVIGIL has not been studied in children under the age of 17. NUVIGIL is not approved for children for any condition.
  • Anyone who has had a rash or allergic reaction to NUVIGIL or PROVIGIL® (modafinil) Tablets [C-IV], or is allergic to any of the following ingredients: modafinil, armodafinil, croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, or pregelatinized starch.
  • Anyone with mitral valve prolapse who has experienced mitral valve prolapse syndrome.

What are possible side effects of NUVIGIL?

  • Common side effects of NUVIGIL are headache, nausea, dizziness, and trouble sleeping.
  • If you experience chest pain, depression, anxiety, hallucinations, psychosis, mania, thoughts of suicide, aggression, or other mental problems, stop taking NUVIGIL and call your doctor right away or get emergency treatment.
  • For more information about other side effects, ask your doctor or pharmacist.

What should I avoid while taking NUVIGIL?

  • Do not drive a car or do other dangerous activities until you and your doctor know how NUVIGIL affects you.
  • Avoid drinking alcohol.

What should I tell my doctor before starting NUVIGIL?

  • Tell your doctor about all of your health conditions including if you have: history of mental health problems (including psychosis), heart problems or had a heart attack, high blood pressure, liver or kidney problems, a history of drug or alcohol abuse or addiction, or are pregnant, planning to become pregnant, or breastfeeding.
  • Women who use hormonal birth control may have a higher chance of getting pregnant, while taking NUVIGIL, and for one month after stopping. Talk to your doctor about other birth control methods while taking NUVIGIL.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or by fax at 1-800-FDA-0178.

For more information, ask your doctor or call 1-800-896-5855.

This information does not take the place of talking with your doctor about your condition or treatment.

Please see the Medication Guide in the full prescribing information for NUVIGIL.

References

  1. US Department of Labor, Bureau of Labor Statistics. Workers on flexible and shift schedules. Bureau of Labor Statistics Web site.
    http://www.bls.gov/news.release/pdf/flex.pdf. Accessed May 11, 2009.
  2. Drake CL, Roehrs T, Richardson G, Walsh JK, Roth T. Shift work sleep disorder: prevalence and consequences beyond that of symptomatic day workers. Sleep. 2004;27(8):1453-1462.
  3. Schwartz JRL, Roth T. Shift work sleep disorder: burden of illness and approaches to management. Drugs. 2006;66(18):2357-2370.
  4. Waage S, Moen BE, Pallesen S, et al. Shift work disorder among oil rig workers in the North Sea. Sleep. 2009;32(4):558-565.
  5. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed, text revision. Washington, DC: American Psychiatric Association; 2000.
  6. American Academy of Sleep Medicine. The International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2nd ed. Westchester, IL: American Academy of Sleep Medicine; 2005.
  7. NUVIGIL [prescribing information]. Frazer, PA: Cephalon, Inc; 2010.
  8. Data on file. Cephalon, Inc.
  9. Littner MR, Kushida C, Wise M, et al. Practice parameters for clinical use of the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test. Sleep. 2005;28(1):113-121.
  10. Czeisler CA, Walsh JK, Wesnes KA, Arora S, Roth T. Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study. Mayo Clin Proc. 2009;84(11):958-972.
  11. IMS HEALTH National Prescription Audit PlusTM (June 2009-February 2010).

NUV-2623 © December 2010 Cephalon, Inc.
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