NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness
(ES) associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder
In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment
for the underlying obstruction. If continuous positive airway pressure (CPAP) is
the treatment of choice for a patient, a maximal effort to treat with CPAP for an
adequate period of time should be made prior to initiating NUVIGIL for excessive
sleepiness. If NUVIGIL is used adjunctively with CPAP, the encouragement of and
periodic assessment of CPAP compliance is necessary. Careful attention to the diagnosis
and treatment of the underlying sleep disorder(s) is of utmost importance.
While NUVIGIL is indicated to treat ES associated with SWD, it is not indicated
to treat SWD itself or other associated symptoms and consequences.
IMPORTANT SAFETY INFORMATION
Contraindications: NUVIGIL 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 NUVIGIL or 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 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.
NUVIGIL has not been studied in pediatric patients in any setting and 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 with NUVIGIL. 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 NUVIGIL and immediately report to their physician
any signs or symptoms suggesting multi-organ hypersensitivity, angioedema or anaphylaxis.
Psychiatric symptoms: Psychiatric adverse experiences have been reported
in patients treated with NUVIGIL and modafinil. In controlled trials in adults administered
NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety,
agitation, nervousness, irritability, and depression. Cases of suicidal ideation,
mania, delusions, hallucinations, and aggression, some resulting in hospitalization,
have been reported in patients treated with NUVIGIL or modafinil. 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.
Persistent sleepiness and CNS effects: 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.
Cardiovascular effects: 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. Small average increases in blood pressure and heart rate
were observed in clinical trials. Increased monitoring of heart rate and blood pressure
may be appropriate in patients on NUVIGIL. Caution should be exercised when prescribing
NUVIGIL to patients with known cardiovascular disease.
Drug interactions: NUVIGIL 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 NUVIGIL and for one month
after discontinuation of therapy.
Common adverse reactions: In clinical trials, the most commonly reported
adverse events (≥5%) associated with the use of NUVIGIL were headache, nausea, dizziness,
Drug abuse and dependence: 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
Physicians should be aware and inform their patients of the availability of the
Medication Guide for NUVIGIL.
Please see 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.