NDAORALTABLET
Approved
Dec 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PROVIGIL (modafinil) by Hikma is mechanism(s) through which modafinil promotes wakefulness is unknown. First approved in 1998.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROVIGIL (modafinil) is an oral sympathomimetic-like wakefulness-promoting agent approved by the FDA in December 1998 for treating excessive sleepiness in adults. It is indicated for narcolepsy, obstructive sleep apnea, and shift work disorder. While modafinil's exact mechanism remains incompletely understood, it appears to work primarily through dopamine transporter inhibition and selective neuronal activation in discrete brain regions, distinguishing it pharmacologically from traditional sympathomimetic amines like amphetamine. The drug represents a standard-of-care option in the sleep disorder and fatigue management treatment landscape.
$0.0BPart D
Mechanism of Action
mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of the sympathomimetic amines. Modafinil-induced…
Worked on PROVIGIL at Hikma? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.