|Systematic (IUPAC) name|
|Legal status||Schedule IV (US) ℞ Prescription only|
|Dependence liability||Very Low|
|Metabolism||Hepatic, including CYP3A4 and other pathways|
|Excretion||Urine (as metabolites)|
|(what is this?)|
Armodafinil (Nuvigil) is a stimulant-like wakefulness-promoting agent produced by the pharmaceutical company Cephalon Inc., which was approved by the U.S. Food and Drug Administration (FDA) on June 15, 2007. Armodafinil is an enantiopure drug consisting of just the active (−)-(R)-enantiomer of the racemic drug modafinil (Provigil). Although they have similar half lives, armodafinil reaches its peak concentration in the blood later after administration than modafinil does, which may make it more effective at improving wakefulness in patients with excessive daytime sleepiness.
Mechanism of action
Armodafinil is currently FDA-approved to treat excessive daytime sleepiness associated with obstructive sleep apnea, narcolepsy, and shift work disorder. It is commonly used off-label to treat attention deficit hyperactivity disorder, chronic fatigue syndrome, and major depressive disorder. It has been shown to improve vigilance in air traffic controllers.
Armodafinil is approved by the U.S. FDA for the treatment of narcolepsy and shift work sleep disorder, and as an adjuvant therapy for obstructive sleep apnea. For narcolepsy and obstructive sleep apnea, armodafinil is taken as a once daily 150 mg or 250 mg dose in the morning. For shift work sleep disorder, 150 mg of armodafinil are taken one hour prior to starting work. Slow dose titration is needed to mitigate some side effects.
In June, 2010, it was revealed that a phase II study of armodafinil as an adjunctive therapy in adults with schizophrenia had failed to meet the primary endpoints, and the clinical program was subsequently terminated. However, a study published later that year showed that schizophrenic patients treated with armodafinil showed fewer of the negative symptoms of schizophrenia.
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- Kane, J. M.; d'Souza, D. C.; Patkar, A. A.; Youakim, J. M.; Tiller, J. M.; Yang, R.; Keefe, R. S. E. (2010). "Armodafinil as Adjunctive Therapy in Adults with Cognitive Deficits Associated with Schizophrenia". The Journal of Clinical Psychiatry 71 (11): 1475–1481. doi:10.4088/JCP.09m05950gry. PMID 20816042.
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