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PROVIGIL (MODAFINIL): PRECAUTIONS

Diagnosis of Sleep Disorders

Provigil (Modafinil) should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of either narcolepsy, OSA, and/or SWD has been made in accordance with ICSD or DSM diagnostic criteria. Such an evaluation usually consists of a complete history and physical examination, and it may be supplemented with testing in a laboratory setting. Some patients may have more than one sleep disorder contributing to their excessive sleepiness (e.g., OSA and SWD coincident in the same patient).

General

Although modafinil has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until they are reasonably certain that Modafinil (Provigil) therapy will not adversely affect their ability to engage in such activities.

CPAP Use in Patients with OSA

In OSA, Provigil (Modafinil) is indicated as an adjunct to standard treatment(s) 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 Provigil (Modafinil) tablets. If this medicine is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.

Cardiovascular System

Modafinil (Provigil) has not been evaluated in patients with a recent history of myocardial infarction or unstable angina, and such patients should be treated with caution.

In clinical studies of Provigil (Modafinil), signs and symptoms including chest pain, palpitations, dyspnea and transient ischemic T-wave changes on ECG were observed in three subjects in association with mitral valve prolapse or left ventricular hypertrophy. It is recommended that Provigil (Modafinil) tablets 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. Such signs may include but are not limited to ischemic ECG changes, chest pain, or arrhythmia. If new onset of any of these symptoms occurs, consider cardiac evaluation.

Blood pressure monitoring in short-term ( < 3 months) controlled trials showed no clinically significant changes in mean systolic and diastolic blood pressure in patients receiving Modafinil (Provigil) tablets as compared to placebo. However, a retrospective analysis of the use of antihypertensive medication in these studies showed that a greater proportion of patients on Provigil required new or increased use of antihypertensive medications (2.4%) compared to patients on placebo (0.7%). The differential use was slightly larger when only studies in OSA were included, with 3.4% of patients on Provigil (Modafinil) and 1.1% of patients on placebo requiring such alterations in the use of antihypertensive medication. Increased monitoring of blood pressure may be appropriate in patients on this medication.

Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe Modafinil (Provigil).

Provigil is indicated for patients who have abnormal levels of sleepiness. This medicine has been shown to improve, but not eliminate this abnormal tendency to fall asleep. Therefore, patients should not alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with Provigil (Modafinil) tablets has been shown to produce levels of wakefulness that permit such activities. Patients should be advised that this medication is not a replacement for sleep.

Patients should be informed that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSA receiving CPAP should continue to do so).

Patients should be informed of the availability of a Medication Guide, and they should be instructed to read it prior to taking Modafinil (Provigil) tablets.

Patients should be advised to contact their physician if they experience chest pain, rash, depression, anxiety, or signs of psychosis or mania.

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