NUVIGIL is contraindicated in patients with known hypersensitivity to modafinil
or armodafinil or its inactive ingredients.
Serious rash, including Stevens-Johnson Syndrome (SJS), requiring hospitalization
and discontinuation of treatment, has been reported in adults in association with
the use of armodafinil and modafinil, and in children in association with use of
NUVIGIL has not been studied in pediatric patients in any setting and is not
approved for use in pediatric patients for any indication.
In pediatric clinical trials of modafinil, a racemic mixture of S- and R-modafinil
(the latter is armodafinil), cases of serious rash including 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.
No serious skin rashes were reported in adult clinical trials of armodafinil.
However, cases of serious rash similar to those observed with modafinil including
skin and mouth blistering have been reported in adults in postmarketing experience.
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
NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious.
NUVIGIL 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 NUVIGIL. Multi-organ hypersensitivity
reactions, including at least one fatality postmarketing, have occurred in close
temporal association to the initiation of modafinil. Patients should be advised
to discontinue NUVIGIL and immediately report to their physician any signs or symptoms
suggesting multi-organ hypersensitivity, angioedema or anaphylaxis.
Patients should be advised that their level of wakefulness may not return to normal.
Although NUVIGIL 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.
Psychiatric adverse experiences have been reported in patients treated with modafinil.
Postmarketing adverse events associated with the use of modafinil have included
mania, delusions, hallucinations, suicidal ideation and aggression, some resulting
in hospitalization. In controlled trials in adults administered NUVIGIL, psychiatric
symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness,
and irritability. Caution should be exercised when NUVIGIL is given to patients
with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL
if psychiatric symptoms develop.
Patients with a recent history of myocardial infarction or unstable angina should
be treated with caution. NUVIGIL should not be used 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.
There were also a greater proportion of patients on NUVIGIL requiring new or increased
use of antihypertensive medications compared to patients on placebo. Increased monitoring
of blood pressure may be appropriate in patients on NUVIGIL.
NUVIGIL 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 NUVIGIL and for one month after discontinuation of therapy. The concomitant
use of NUVIGIL and alcohol has not been studied and should be avoided.
In clinical trials, the most commonly reported adverse events (≥5%) were headache,
nausea, dizziness, and insomnia. Most adverse experiences were rated as mild to
NUVIGIL 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 NUVIGIL.
Full Prescribing Information for NUVIGIL.
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.