IMPORTANT INFORMATION FOR PHYSICIANS
PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness
associated with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder
In OSA, PROVIGIL is indicated as an adjunct to standard treatment(s) for the underlying
obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice,
the encouragement of and periodic assessment of CPAP compliance is necessary and
a maximal effort to treat with CPAP for an adequate period of time should be made
prior to initiating PROVIGIL. Careful attention to the diagnosis and treatment of
the underlying sleep disorder(s) is important.
IMPORTANT SAFETY INFORMATION
PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil,
armodafinil or its inactive ingredients.
Serious rash, including Stevens Johnson Syndrome (SJS), requiring hospitalization
and discontinuation of treatment has been reported in adults and children in association
with use of modafinil.
Modafinil is not approved for use in pediatric patients for any indication.
In pediatric clinical trials of modafinil, cases of possible SJS and apparent
multi-organ hypersensitivity reaction have been reported. Several of the cases were
associated with fever and other abnormalities (e.g., vomiting, leukopenia). No serious
skin rashes have been reported in adult clinical trials of modafinil. Rare cases
of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN)
and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported
in adults and children in postmarketing experience with 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 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.
Cases of angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm)
were observed among patients treated with modafinil. Patients should be advised
to discontinue therapy and immediately report to their physician any signs or symptoms
suggesting angioedema or anaphylaxis.
Multi-organ hypersensitivity reactions, including at least one fatality postmarketing,
have occurred in close temporal association to the initiation of modafinil. If a
multi-organ hypersensitivity reaction is suspected, PROVIGIL should be discontinued.
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, if appropriate, advised
to avoid driving or any other potentially dangerous activity.
Psychiatric adverse experiences have been reported in patients treated with modafinil.
Postmarketing adverse events have included mania, delusions, hallucinations, suicidal
ideation and aggression, some resulting in hospitalization. In controlled trials
in adults, psychiatric symptoms resulting in treatment discontinuation were anxiety,
nervousness, insomnia, confusion, agitation, and depression. Caution should be exercised
when PROVIGIL is given to patients with a history of psychosis, depression, or mania.
Consider discontinuing PROVIGIL if psychiatric symptoms develop.
Patients with a recent history of myocardial infarction or unstable angina should
be treated with caution. PROVIGIL tablets should not be used in patients with a
history of left ventricular hypertrophy or in patients with mitral valve prolapse
who have experienced the mitral valve prolapse syndrome when previously receiving
CNS stimulants. There were also a greater proportion of patients on PROVIGIL requiring
new or increased use of antihypertensive medications compared to patients on placebo.
Increased monitoring of blood pressure may be appropriate in patients on PROVIGIL.
PROVIGIL may interact with drugs that inhibit, induce, or are metabolized by cytochrome
P450 isoenzymes. The effectiveness of steroidal contraceptives may be reduced when
used with PROVIGIL tablets and for one month after discontinuation of therapy. The
concomitant use of PROVIGIL and alcohol has not been studied and should be avoided.
In clinical trials, the most commonly reported adverse events ((≥5%) were headache,
nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness,
and dyspepsia. Most adverse experiences were rated as mild to moderate.
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 a Medication Guide for PROVIGIL.
Please see Full Prescribing Information for PROVIGIL.
A pregnancy registry has been established to collect information on the pregnancy
outcomes of women exposed to PROVIGIL. Healthcare providers are encouraged to register
pregnant patients, or pregnant women may enroll themselves in the registry by calling
For more information about the PROVIGIL pregnancy registry, please visit www.PROVIGILpregnancyregistry.com.