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Drug ReportsArmodafinil
Armodafinil
Armodafinil, Nuvigil (armodafinil) is a small molecule pharmaceutical. Armodafinil was first approved as Nuvigil on 2007-06-15. It is used to treat sleep wake disorders in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Armodafinil, Nuvigil (discontinued: Armodafinil, Nuvigil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Armodafinil
Tradename
Company
Number
Date
Products
NUVIGILNuvo PharmaceuticalsN-021875 RX2007-06-15
4 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
armodafinilANDA2026-03-06
nuvigilNew Drug Application2026-09-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sleep wake disorders—D012893G47
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06B: Psychostimulants, agents used for adhd and nootropics
— N06BA: Centrally acting sympathomimetics
— N06BA13: Armodafinil
HCPCS
No data
Clinical
Clinical Trials
63 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SleepinessD000077260—R40.012113116
FatigueD005221—R53.831733315
Obstructive sleep apneaD020181EFO_0003918G47.33——6219
Sleep apnea syndromesD012891EFO_0003877G47.3——6219
Disorders of excessive somnolenceD006970—G47.1—15218
Sleep wake disordersD012893—G47——4127
ApneaD001049—R06.81——42—6
DepressionD003863—F33.9—141—6
Depressive disorderD003866EFO_1002014F32.A—141—6
SchizophreniaD012559EFO_0000692F20—2—1—3
Show 15 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NarcolepsyD009290EFO_0000614G47.41—4—27
Circadian rhythm sleep disordersD020178—G47.2——4—26
ParasomniasD020447—G47.5——4—15
ObesityD009765EFO_0001073E66.9——2——2
SyndromeD013577————2——2
Wounds and injuriesD014947—T14.8——2——2
Traumatic brain injuriesD000070642—S06——2——2
Brain injuriesD001930—S06.9——2——2
Multiple sclerosisD009103EFO_0003885G35—11——1
SclerosisD012598———11——1
Show 8 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep initiation and maintenance disordersD007319—F51.01—2——13
Healthy volunteers/patients———31———3
GliomaD005910EFO_0000520——2———2
Head and neck neoplasmsD006258——22———2
Non-small-cell lung carcinomaD002289——11——12
Lung neoplasmsD008175—C34.9011——12
Cognition disordersD003072———2———2
NeoplasmsD009369—C80—2———2
Sleep deprivationD012892—F51.12—1———1
Cognitive dysfunctionD060825—G31.84—1———1
Show 7 more
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C95————11
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—————11
Myeloid leukemiaD007951—C92————11
Parkinson diseaseD010300EFO_0002508G20————11
LymphomaD008223—C85.9————11
B-cell lymphomaD016393——————11
Pregnancy rateD018873——————11
Idiopathic hypersomniaD020177—G47.11————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameArmodafinil
INNarmodafinil
Description
Armodafinil is a 2-[(diphenylmethyl)sulfinyl]acetamide that has R configuration at the sulfur atom. Like its racemate, modafinil, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. Peak concentration in the blood later occurs later following administration than with modafinil, so it is thought that armodafinil may be more effective than modafinil in treating people with excessive daytime sleepiness. It has a role as a central nervous system stimulant and a eugeroic. It is an enantiomer of a (S)-modafinil.
Classification
Small molecule
Drug classAtypical dopamine reuptake inhibitor; wakefulness-promoting agent
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Structure (InChI/SMILES or Protein Sequence)
NC(=O)C[S@@+]([O-])C(c1ccccc1)c1ccccc1
Identifiers
PDB—
CAS-ID112111-43-0
RxCUI—
ChEMBL IDCHEMBL1201192
ChEBI ID77590
PubChem CID9690109
DrugBank—
UNII IDV63XWA605I (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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Nuvigil – Cephalon
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Estimated US medical usage
Armodafinil
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,270 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,176 adverse events reported
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