Shift Work Disorder Symptoms | NUVIGIL® (armodafinil) Tablets [C-IV]

IMPORTANT SAFETY INFORMATION

NUVIGIL^® (armodafinil) Tablets [C-IV] may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells, and may result in hospitalization and be life-threatening. If you develop a skin rash, hives, sores in your mouth, blisters, swelling, peeling, or yellowing of the skin or eyes, trouble swallowing or breathing, dark urine, or fever, stop taking NUVIGIL and call your doctor right away or get emergency help.

Could excessive sleepiness (ES) be one of your symptoms of shift work disorder (SWD)?

Primary symptoms of SWD include being very sleepy (excessive sleepiness) during waking hours and having trouble sleeping (insomnia). Excessive sleepiness is defined as having trouble staying awake enough to do the things you usually do. Getting treatment for insomnia will not necessarily resolve your excessive sleepiness.^1-4

Ask yourself:

Do I work shifts or a non-traditional work schedule?
Do I feel tired or sleepy when I need to be awake?
Is my work, home, or social life negatively affected?

If you answered yes to all 3 questions, then you could be suffering from one of the SWD symptoms, ES.²

What are the consequences of shift work disorder?

Shift work disorder (SWD) can lead to other issues:⁵

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

NUVIGIL has not been demonstrated to affect any of these potential consequences of SWD.

Who is at risk for shift work disorder?

Excessive sleepiness (ES) due to SWD can affect anyone working nights, early mornings, or rotating shifts. A wide range of occupations require either permanent or occasional shift work.⁶

While SWD can affect men and women of all ages, some factors may cause even greater problems coping with symptoms:⁷

Age greater than 50 years
History of sleep disorders
History of stomach disorders
Diabetes
Heart disease

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.⁴

IMPORTANT SAFETY INFORMATION FOR NUVIGIL

What is NUVIGIL?

NUVIGIL^® (armodafinil) Tablets [C-IV] is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work disorder (SWD), 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 OSA treatment, and it is important that you continue to use this treatment as prescribed by your doctor.

NUVIGIL may help the sleepiness caused by these conditions, but it may not stop all of your sleepiness and does not take the place of sleep.

NUVIGIL is a federally controlled substance (C-IV), so use NUVIGIL only as directed and keep in a safe place to prevent misuse and abuse. It is against the law to sell or give NUVIGIL to another person.

What important information should I know about NUVIGIL?

NUVIGIL may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells, and may result in hospitalization and be life-threatening. If you develop a skin rash, hives, sores in your mouth, blisters, swelling, peeling, or yellowing of the skin or eyes, trouble swallowing or breathing, dark urine, or fever, stop taking NUVIGIL and call your doctor right away or get emergency help.
NUVIGIL is not approved for children for any condition. It is not known if NUVIGIL is safe or if it works in children under the age of 17
You should not take NUVIGIL if you have had a rash or allergic reaction to NUVIGIL or PROVIGIL^® (modafinil) Tablets [C-IV], or are allergic to any of the following ingredients: modafinil, armodafinil, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, or pregelatinized starch

What are possible side effects of NUVIGIL?

Stop taking NUVIGIL and call your doctor or get emergency help if you get any of the following serious side effects:
- Mental (psychiatric) symptoms, including: depression, feeling anxious, sensing things that are not really there, extreme increase in activity (mania), thoughts of suicide, aggression, or other mental problems
- Symptoms of a heart problem, including: chest pain, abnormal heart beat, and trouble breathing
Common side effects of NUVIGIL are headache, nausea, dizziness, and trouble sleeping. These are not all the side effects of NUVIGIL
Tell your doctor if you get any side effect that bothers you or that does not go away. Talk to your doctor for medical advice about side effects

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
Tell your doctor about all of the medicines you take. Women who use hormonal birth control may have a higher chance of getting pregnant, while taking and for one month after stopping NUVIGIL. Talk to your doctor about other birth control methods while taking NUVIGIL

You are encouraged to report 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 for medical advice about your condition or treatment.

Please read the Medication Guide for Patients in the Full Prescribing Information for NUVIGIL.

There is a registry for women who become pregnant during treatment with NUVIGIL. The purpose of this registry is to collect information about the safety of NUVIGIL during pregnancy. You or your doctor can get information and enroll you in the registry by calling 1-866-404-4106 or by visiting www.NUVIGILpregnancyregistry.com.

References

Schwartz JRL, Roth T. Shift work sleep disorder: burden of illness and approaches to management. Drugs. 2006;66(18):2357-2370.
Ohayon MM. From wakefulness to excessive sleepiness: what we know and still need to know. Sleep Med Rev. 2008;12(2):129-141.
Morgenthaler TI, Lee-Chiong T, Alessi C, et al. Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders. Sleep. 2007;30(11):1445-1459.
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.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed, text revision. Washington, DC: American Psychiatric Association; 2000.
US Department of Labor, Bureau of Labor Statistics. Workers on flexible and shift schedules. Bureau of Labor Statistics website. Available at http://www.bls.gov/news.release/pdf/flex.pdf. Accessed May 12, 2010.
Monk, Timothy H. Shift Work: Basic Principles. In: Kryger MH, Roth T, Dement WC, eds. Principles and Practice of Sleep Medicine. 4th ed. Philadelphia, PA: Elsevier Saunders;
2005:673-679.

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