INDICATIONS AND USAGE
NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness
associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder
Limitations of Use
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 and during treatment
with NUVIGIL for excessive sleepiness.
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 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 in patients 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 angioedema or anaphylaxis, or multi-organ
Psychiatric symptoms: Psychiatric adverse experiences have been
reported in patients treated with NUVIGIL and modafinil. In controlled trials in
adults treated with NUVIGIL, psychiatric symptoms resulting in treatment discontinuation
included anxiety, agitation, nervousness, irritability, 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 NUVIGIL is given to patients with a history of
psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms
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 events: Cardiovascular adverse reactions have been
reported in patients treated with modafinil in association with mitral valve prolapse
or left ventricular hypertrophy. NUVIGIL 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.
In clinical studies, a greater proportion of patients on NUVIGIL 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 NUVIGIL.
Caution should be exercised when prescribing NUVIGIL to patients with known cardiovascular
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 reactions (≥5%) associated with the use of NUVIGIL were headache,
nausea, dizziness, and insomnia
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 the
Medication Guide for NUVIGIL.
Please see Full Prescribing Information for