NUVIGIL is a prescription medicine used to improve wakefulness in adults who are
very sleepy due to one of the following diagnosed sleep disorders:
- obstructive sleep apnea (OSA). NUVIGIL is used with other medical treatments
for this disorder. NUVIGIL does not take the place of using your CPAP machine or
other treatments that your doctor has prescribed for this condition. It is important
that you continue to use these treatments as prescribed by your doctor.
- shift work disorder (SWD)
NUVIGIL will not cure these sleep disorders. NUVIGIL may help the sleepiness caused
by these conditions, but it may not stop all your sleepiness. NUVIGIL does not take
the place of getting enough sleep.
NUVIGIL is a federally controlled substance (C-IV) because it can be abused or lead
to dependence. Keep NUVIGIL in a safe place to prevent misuse and abuse. Selling
or giving away NUVIGIL may harm others, and is against the law.
IMPORTANT SAFETY INFORMATION FOR NUVIGIL
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. Any
of these may need to be treated in a hospital and may be life-threatening.
Stop taking NUVIGIL and call your doctor right away or get emergency help if you
have any of these symptoms: skin rash, hives, sores in your mouth, or your
skin blisters and peels; swelling of your face, eyes, lips, tongue, or throat; trouble
swallowing or breathing; or fever, shortness of breath, swelling of the legs, yellowing
of the skin or whites of the eyes, or dark urine.
If you have a severe rash with NUVIGIL, stopping the medicine may not keep the rash
from becoming life-threatening or causing you to be permanently disabled or disfigured.
NUVIGIL is not approved for use in children for any medical condition. It
is not known if NUVIGIL is safe or if it works in children under the age of 17 years.
Who should not take NUVIGIL?
Do not take NUVIGIL if you are allergic to any of its ingredients or have had a
rash or allergic reaction to either armodafinil (NUVIGIL) or modafinil (PROVIGIL®).
These medicines are very similar.
What should I tell my doctor before taking NUVIGIL?
Tell your doctor about all of your medical conditions including, if you have
a history of mental health problems, including psychosis; have heart problems or
had a heart attack; have high blood pressure; have liver or kidney problems; have
a history of drug or alcohol abuse or addiction; are pregnant or planning to become
pregnant; or are breastfeeding.
Tell your doctor about all the medicines you take, including prescription
and non-prescription medicines, vitamins, and herbal supplements. Hormonal birth
control methods may not work while you take NUVIGIL. Women who use one of these
methods of birth control may have a higher chance for getting pregnant while taking
NUVIGIL, and for one month after stopping NUVIGIL.
What should I avoid while taking NUVIGIL?
- Do not drive a car or do other dangerous activities until you know how NUVIGIL
- You should avoid drinking alcohol.
What are possible side effects of NUVIGIL?
NUVIGIL may cause serious side effects. Stop taking NUVIGIL and call your
doctor right away or get emergency help if you get any of the following:
- a serious rash or serious allergic reaction (see above)
- mental (psychiatric) symptoms, including: depression; feeling anxious;
hearing, seeing, feeling, or sensing things that are not really there (hallucinations);
an extreme increase in activity and talking (mania); thoughts of suicide; aggressive
behavior, and other mental problems
- symptoms of a heart problem, including chest pain, abnormal heart beats,
and trouble breathing.
Common side effects of NUVIGIL include headache, nausea, dizziness, and trouble
Tell your doctor if you get any side effect that bothers you or that does not go
away while taking NUVIGIL.
These are not all the side effects of NUVIGIL. For more information, ask your doctor
or pharmacist. Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.
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.