NUVIGIL

LOE Approaching

armodafinil

NDAORALTABLET
Approved
Jun 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

mechanism(s) through which armodafinil promotes wakefulness is unknown. Armodafinil (R-modafinil) has pharmacological properties similar to those of modafinil (a mixture of R- and S-modafinil), to the extent tested in animal and in vitro studies. The R- and S-enantiomers have similar…

Indications (4)

excessive sleepinesswakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA)narcolepsyshift work disorder (SWD)

Clinical Trials (5)

NCT02552303N/ACompleted

The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia

Started Apr 2014
39 enrolled
Sleep ApneaInsomnia
NCT01781468Phase 3Completed

Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

Started Jun 2013
328 enrolled
Fatigue
NCT01624480Phase 1Completed

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

Started Jul 2012
40 enrolled
Narcolepsy
NCT01460628Phase 4Completed

Effect of Nuvigil on Fatigue

Started Oct 2011
25 enrolled
Menopause
NCT01305408Phase 3Completed

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Started Mar 2011
399 enrolled
Depression
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers