"The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder ("non-24") in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorde"...
Physicians are advised to discuss the following issues with patients for whom they prescribe PROVIGIL (modafinil) .
PROVIGIL (modafinil) is indicated for patients who have abnormal levels of sleepiness. PROVIGIL (modafinil) 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) has been shown to produce levels of wakefulness that permit such activities. Patients should be advised that PROVIGIL (modafinil) 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 PROVIGIL (modafinil) . The complete text of the Medication Guide is provided at the end of this labeling.
Patients should be advised to contact their physician if they experience chest pain, rash, depression, anxiety, or signs of psychosis or mania.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Patients should be cautioned regarding the potential increased risk of pregnancy when using steroidal contraceptives (including depot or implantable contraceptives) with PROVIGIL (modafinil) and for one month after discontinuation of therapy (See Carcinogenesis, Mutagenesis, Impairment of Fertility and Pregnancy).
Patients should be advised to notify their physician if they are breast feeding an infant.
Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, because of the potential for interactions between PROVIGIL (modafinil) and other drugs.
Patients should be advised that the use of PROVIGIL (modafinil) in combination with alcohol has not been studied. Patients should be advised that it is prudent to avoid alcohol while taking PROVIGIL (modafinil) .
Patients should be advised to stop taking PROVIGIL (modafinil) and to notify their physician if they develop a rash, hives, mouth sores, blisters, peeling skin, trouble swallowing or breathing or a related allergic phenomenon.
Last reviewed on RxList: 11/29/2010
This monograph has been modified to include the generic and brand name in many instances.
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