NUVIGIL was studied in four 12-week clinical trials
The clinical trials included more than 1100 patients with these disorders
People who took NUVIGIL experienced significant improvement in wakefulness
In 2 studies of people with treated OSA and a study of people with narcolepsy, NUVIGIL was tested using the Maintenance of Wakefulness Test (MWT), 4 times throughout the day. In these studies, the measures were taken between 9 am and 3 pm1-4
In a study of people with SWD, NUVIGIL was tested using the Multiple Sleep Latency Test (MSLT), 4 times throughout the patients' night shift. In this study, the measures were taken between 2 am and 8 am5
The MWT and MSLT are measures of a person's degree of sleepiness
NUVIGIL does not affect sleep, as shown in sleep studies.1
Based on sleep studies that measure nighttime breathing and brain and muscle activity, NUVIGIL does NOT interfere with sleep.
In these studies, most people (95%) taking NUVIGIL did not report trouble sleeping (5% reported trouble sleeping). 1% of people taking a sugar pill (placebo) reported trouble sleeping
NUVIGIL is generally well tolerated.1
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
7% of people taking NUVIGIL stopped treatment due to side effects, compared with 4% of people taking a sugar pill (placebo)
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.
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.
Share your story and tell us about your experience with NUVIGIL.
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.
Important Safety Information
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 monohydrate, 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.
References: 1. NUVIGIL [prescribing information]. Frazer, PA: Cephalon, Inc; 2010.
2. Roth T, White D, Schmidt-Nowara W, et al. Effects of armodafinil in the treatment of residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome: a 12-week, multicenter, double-blind, randomized, placebo-controlled study in nCPAP-adherent adults. Clin Ther. 2006;28(5):689-706.
3. Data on file. Cephalon, Inc.
4. Harsh JR, Hayduk R, Rosenberg R, et al. The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy. Curr Med Res Opin. 2006;22(4):761-774.
5. 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.
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