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NUVIGIL (ARMODAFINIL) TABLETS: OVERDOSAGE

Human Experience

There were no overdoses reported in the Armodafinil (Nuvigil) tablets clinical studies. Symptoms of Nuvigil overdose are likely to be similar to those of modafinil. Overdose in modafinil clinical trials included excitation or agitation, insomnia, and slight or moderate elevations in hemodynamic parameters. From post-marketing experience with modafinil, there have been no reports of fatal overdoses involving modafinil alone (doses up to 12 grams). Overdoses involving multiple drugs, including modafinil, have resulted in fatal outcomes. Symptoms most often accompanying modafinil overdose, alone or in combination with other drugs have included; insomnia; central nervous system symptoms such as disorientation, restlessness, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension and chest pain.

Overdose Management

No specific antidote exists for the toxic effects of a Nuvigil (Armodafinil) overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring. If there are no contraindications, induced emesis or gastric lavage should be considered. There are no data to suggest the utility of dialysis or urinary acidification or alkalinization in enhancing drug elimination. The physician should consider contacting a poison-control center for advice in the treatment of any overdose.

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