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Glossary
Clinical Global Impression of Change (CGI-C)1
The CGI-C is a standard assessment tool used by doctors to measure the impact of symptoms or disease on your overall medical condition. In addition, it allows your doctor to track your response to treatment. Using a 7-point scale, a change in your overall condition is measured using the CGI-C that ranges from Very Much Improved to Very Much Worse .
Continuous positive airway pressure (CPAP)2
CPAP is the most common treatment for obstructive sleep apnea (OSA). CPAP is delivered through a machine that provides a stream of compressed air through a hose to a nasal pillow, nose mask, or full-face mask. This delivery allows for unobstructed breathing to take place, making it easier for a person to breathe during sleep.
Epworth Sleepiness Scale (ESS)3,4
The ESS measures your general level of sleepiness. It asks you to rate the chance that you would doze off during 8 routine daytime situations. Your score can help you start a conversation with your doctor about excessive sleepiness (ES) and underlying causes of ES such as treated obstructive sleep apnea (OSA), shift work disorder (SWD), formerly known as shift work sleep disorder, and narcolepsy.
Excessive sleepiness (ES)5
ES is defined as having trouble staying awake enough to do the things you usually do.
Isomer6,7
Isomers are two or more compounds that have the same number and kinds of atoms but have different chemical characteristics. NUVIGIL is made of R-modafinil, the longer-lasting R-isomer of modafinil.
Karolinska Sleepiness Scale (KSS)8
A questionnaire used to measure your overall level of sleepiness on a 9-point scale, ranging from 1 (very alert) to 9 (very sleepy, great effort to stay awake, fighting sleep).
Maintenance of Wakefulness Test (MWT)9
The MWT is an assessment of sleepiness that measures a person's ability to stay awake in the controlled environment of a sleep lab.
Modafinil6,7,10
Modafinil contains only 50% of the longer-lasting R-isomer found in NUVIGIL. The other 50% is a shorter-lasting isomer called S-modafinil.
Multiple Sleep Latency Test (MSLT)9
Administered by a physician in a sleep lab, an MSLT is an assessment of sleepiness that measures a person's likelihood of falling asleep. The test measures the time it takes one to get to sleep when given 20 minutes to do so.
Narcolepsy11,12
Narcolepsy is a sleep disorder involving the brain. Narcolepsy occurs when the brain is unable to normally regulate cycles of sleep and waking. This can cause people with narcolepsy to experience excessive sleepiness, including episodes of falling asleep suddenly.
Obstructive sleep apnea (OSA)12-14
OSA is caused by a blockage in a person's airway that can disrupt breathing during sleep. This disruption in breathing can cause a person to wake repeatedly throughout the night and can have serious health consequences.
Placebo-controlled study
In a placebo-controlled study, one group of patients is given an active drug and another group of patients is given a placebo, also called a sugar pill, which has no clinical effect. The results from these two groups are then compared at the end of the study to determine the effects of the active drug.
R-modafinil/armodafinil6,7
R-modafinil, or armodafinil, is the generic name for NUVIGIL. R-modafinil is the longer-lasting isomer of modafinil, a similar medicine.
Shift workers12
Traditionally, people thought of as shift workers include nurses, factory workers, and truck drivers. But in today's world, this category has grown to include people who work other types of non-traditional schedules, including chefs, radio DJs, stockbrokers, and many other kinds of jobs.
Many people who work shifts or a non-traditional schedule may not have the option to work a different schedule.
Shift work disorder (SWD), or shift work sleep disorder12
SWD occurs when the body's internal sleep-wake clock is out of sync with the work schedule (the body wants to go to sleep when it needs to stay awake). Because of this disruption of the body's natural rhythm, people with SWD often struggle to stay awake during their waking hours or have trouble sleeping during their sleeping hours.
Important Safety Information
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
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.
Guy W. ECDEU Assessment Manual for Psychopharmacology, revised 1976. Rockville, MD: National Institute of Mental Health; 1976.
Institute for Clinical Systems Improvement. Health Care Guideline: Diagnosis and Treatment of Obstructive Sleep Apnea. 6th ed. Bloomington, MN: Institute for Clinical Systems Improvement; 2008.
Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep. 1991;14(6):540-545.
Johns MW. Reliability and factor analysis of the Epworth Sleepiness Scale. Sleep. 1992;15(4):376-381.
Ohayon MM. From wakefulness to excessive sleepiness: what we know and still need to know. Sleep Med Rev. 2008;12(2):129-141.
NUVIGIL [prescribing information]. Frazer, PA: Cephalon, Inc; 2010.
Nishino S, Okuro M. Armodafinil for excessive daytime sleepiness. Drugs Today (Barc). 2008;44(6):395-414.
Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990;52(1-2):29-37.
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.
PROVIGIL [prescribing information]. Frazer, PA: Cephalon, Inc; 2008.
National Institute of Neurological Disorders and Stroke. Narcolepsy Fact Sheet. National Institute of Neurological Disorders and Stroke, National Institutes of Health website. http://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm. Accessed April 26, 2010.
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.
Carney PR, Berry RB, Geyer JD. Clinical Sleep Disorders. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:255.
Attarian HP, Sabri AN. When to suspect obstructive sleep apnea syndrome. Symptoms may be subtle, but treatment is straightforward. Postgrad Med. 2002;111(3):70-76; quiz.