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Clinical data
Trade namesProvigil, Alertec, Modavigil, others
License dataUS   FDA: Modafinil
Pregnancy categoryAU: B3 US: C (Risk not ruled out) [3]
Dependence liabilityPsychological: Very low [1] Physical: Negligible [1]
Addiction liabilityVery low to low [2]
Routes of administrationBy mouth (tablets) [3]
ATC codeN06BA07 ( WHO )
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Legal statusAU: S4 (Prescription only) UK: POM (Prescription only) US: Schedule IV
Pharmacokinetic data
BioavailabilityNot determined due to the aqueous insolubility
Protein binding62.3%
MetabolismHepatic (primarily via amide hydrolysis; [4] CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP3A4, CYP3A5 involved [5]
Elimination half-life15 hours ( R -enantiomer), 4 hours ( S -enantiomer) [6]
ExcretionUrine (80%)

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