52468
document
Armodafinil and modafinil in patients with excessive sleepiness associated with shift work disorder : a pharmacokinetic/pharmacodynamic model for predicting and comparing their concentration-effect relationships . Armodafinil , the longer lasting R-isomer of racemic modafinil , improves wakefulness in patients with excessive sleepiness associated with shift work disorder ( SWD ) . Pharmacokinetic studies suggest that armodafinil achieves higher plasma concentrations than modafinil late in a dose interval following equal oral doses . Pooled Multiple Sleep Latency Test ( MSLT ) data from 2 randomized , double-blind , placebo-controlled trials in 463 patients with SWD , 1 with armodafinil 150 mg/d and 1 with modafinil 200 mg/d ( both administered around 2200 h before night shifts ) , were used to build a pharmacokinetic/pharmacodynamic model . Predicted plasma drug concentrations were obtained by developing and applying a population pharmacokinetic model using nonlinear mixed-effects modeling . Armodafinil 200 mg produced a plasma concentration above the EC ( 50 ) ( 4.6 µg/mL ) for 9 hours , whereas modafinil 200 mg did not exceed the EC ( 50 ) . Consequently , armodafinil produced greater increases in predicted placebo-subtracted MSLT times of 0.5-1 minute ( up to 10 hours after dosing ) compared with modafinil . On a milligram-to-milligram basis , armodafinil 200 mg consistently increased wakefulness more than modafinil 200 mg , including times late in the 8-hour shift .
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Intervention_Pharmacological
Armodafinil and modafinil
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Intervention_Pharmacological
Armodafinil
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Intervention_Pharmacological
armodafinil
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
armodafinil 150 mg/d
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Intervention_Pharmacological
1 with modafinil 200 mg/d
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Outcome_Physical
pharmacokinetic/pharmacodynamic
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Outcome_Physical
wakefulness
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Outcome_Physical
excessive sleepiness
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Outcome_Physical
shift work disorder ( SWD )
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Outcome_Physical
plasma concentrations
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Outcome_Physical
Pooled Multiple Sleep Latency Test ( MSLT )
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Outcome_Physical
pharmacokinetic/pharmacodynamic
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Outcome_Physical
plasma drug concentrations
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Outcome_Physical
pharmacokinetic model
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Outcome_Physical
plasma concentration
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Participant_Condition
excessive sleepiness
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Participant_Condition
excessive sleepiness
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Participant_Condition
shift work disorder
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Participant_Sample-size
463
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Participant_Condition
SWD