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
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:
- A serious rash or serious allergic reaction (see above)
- 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
- 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
You are encouraged to report side effects of prescription drugs to the FDA. Visit
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
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.