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Drug Abuse And Dependence. NUVIGIL contains armodafinil, a Schedule IV controlled substance. Abuse of NUVIGIL has been reported in patients treated with NUVIGIL. Patterns of abuse have included euphoric mood and use of increasingly large doses or recurrent use of NUVIGIL for a desired effect. Drug diversion has also been noted. During the postmarketing period, misuse of NUVIGIL has been observed (e. Abuse of armodafinil, the active ingredient of NUVIGIL, poses a risk of overdosage similar to that seen for modafinil, which may lead to tachycardia, insomnia, agitation, dizziness, anxiety, nausea, headache, dystonia, tremor, chest pain, hypertension, seizures, delirium, or hallucinations. Other signs and symptoms of CNS stimulant abuse include tachypnea, sweating, dilated pupils, hyperactivity, restlessness, decreased appetite, loss of coordination, flushed skin, vomiting, and abdominal pain. In humans, modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings, typical of other CNS stimulants. In in vitro binding studies, modafinil binds to the dopamine reuptake site and causes an increase in extracellular dopamine, but no increase in dopamine release. Modafinil is reinforcing, as evidenced by its self-administration in monkeys previously trained to self-administer cocaine. In some studies, modafinil was also partially discriminated as stimulant-like. Physicians should follow patients closely, especially those with a history of drug and/or stimulant (e. Patients should be observed for signs of misuse or abuse (e. The abuse potential of modafinil (200, 400, and 800 mg) was assessed relative to methylphenidate (45 and 90 mg) in an inpatient study in individuals experienced with drugs of abuse. Results from this clinical study demonstrated that modafinil produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants (methylphenidate). Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Physical dependence can occur in patients treated with NUVIGIL. Abrupt cessation or dose reduction following chronic use can result in withdrawal symptoms, including shaking, sweating, chills, nausea, vomiting, confusion, aggression, and atrial fibrillation. Drug withdrawal convulsions, suicidality, fatigue, insomnia, aches, depression and headache have also been observed during the postmarketing period. Also, abrupt withdrawal has caused deterioration of psychiatric symptoms such as depression. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i. Multiple cases of development of tolerance to NUVIGIL have been reported during the postmarketing period, altamofen 20 mg antiestrogens nolvadex. Included as part of the PRECAUTIONS section. Serious Dermatologic Reactions, including Stevens-Johnson Syndrome And Toxic Epidermal Necrosis.
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