41 Moores Road
Frazer, PA 19355
To request information about PROVIGIL, contact us at 1-800-896-5855 or:
Patients submit your request here
Healthcare Professionals submit your request here
For more information about the PROVIGIL pregnancy registry, please visit www.provigilpregnancyregistry.com.
IMPORTANT SAFETY INFORMATION
Contraindications: PROVIGIL is contraindicated in patients with
a known hypersensitivity to modafinil or armodafinil or its inactive ingredients.
Serious rash: Serious rash, including Stevens-Johnson Syndrome,
requiring hospitalization and discontinuation of treatment has been reported in
association with the use of modafinil. There are no factors, including duration
of therapy, that are known to predict the risk of occurrence or the severity of
rash. Although benign rashes also occur with PROVIGIL, it is not possible to reliably
predict which rashes will prove to be serious. PROVIGIL should ordinarily be discontinued
at the first sign of rash unless the rash is clearly not drug-related.
PROVIGIL is not approved for use in pediatric patients for any indication.
Angioedema and hypersensitivity reactions: Angioedema and hypersensitivity
(with rash, dysphagia, and bronchospasm) were observed in patients treated with
armodafinil. Angioedema has been reported in postmarketing experience with modafinil.
Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing
experience, have occurred in close temporal association to the initiation of modafinil.
Patients should be advised to discontinue PROVIGIL and immediately report to their
physician any signs or symptoms suggesting multi-organ hypersensitivity, angioedema
Psychiatric symptoms: Psychiatric adverse experiences have been
reported in patients treated with modafinil. In controlled trials in adults treated
with PROVIGIL, psychiatric symptoms resulting in treatment discontinuation included
anxiety, nervousness, insomnia, confusion, agitation, and depression. Postmarketing
adverse reactions associated with the use of modafinil have included mania, delusions,
hallucinations, suicidal ideation, and aggression, some resulting in hospitalization.
Caution should be exercised when PROVIGIL is given to patients with a history of
psychosis, depression, or mania. Consider discontinuing PROVIGIL if psychiatric
Persistent sleepiness and CNS effects: Patients should be advised
that their level of wakefulness may not return to normal. Although PROVIGIL has
not been shown to produce functional impairment, any drug affecting the CNS may
alter judgment, thinking or motor skills. Patients should be frequently reassessed
for their degree of sleepiness and functional impairment and, if appropriate, advised
to avoid driving or any other potentially dangerous activity.
Cardiovascular effects: Cardiovascular adverse reactions have been
reported in patients treated with modafinil in association with mitral valve prolapse
or left ventricular hypertrophy. PROVIGIL is not recommended in patients with a
history of left ventricular hypertrophy or in patients with mitral valve prolapse
who have experienced mitral valve prolapse syndrome when previously receiving CNS
stimulants. If findings of mitral valve prolapse syndrome occur, consider cardiac
evaluation. Consider increased monitoring in patients with a recent history of myocardial
infarction or unstable angina. In clinical studies, a greater proportion of patients
on PROVIGIL required new or increased use of antihypertensive medications compared
to patients on placebo. Increased monitoring of heart rate and blood pressure may
be appropriate in patients on PROVIGIL. Caution should be exercised when prescribing
PROVIGIL to patients with known cardiovascular disease.
Drug interactions: PROVIGIL may interact with drugs that are substrates
for CYP3A4/5 or CYP2C19. Dose adjustment of these drugs may be required. The effectiveness
of steroidal contraceptives may be reduced when used with PROVIGIL and for one month
after discontinuation of therapy.
Common adverse reactions: In clinical trials, the most commonly
reported adverse reactions (≥5%) associated with the use of PROVIGIL were headache,
nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness,
PROVIGIL is a Schedule IV controlled substance because it has the potential to be
abused or lead to dependence. Physicians should follow patients closely, especially
those with a history of drug and/or stimulant abuse.
Physicians should be aware and inform their patients of the availability of the
Guide for PROVIGIL.
Please see Full Prescribing Information for PROVIGIL.