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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Trade Name
FDA
EMA
Nuvigil (generic drugs available since 2012-06-01)
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 |
|---|---|---|---|---|
| NUVIGIL | Cephalon | N-021875 RX | 2007-06-15 | 4 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| armodafinil | NDA authorized generic | 2023-01-31 |
| nuvigil | New Drug Application | 2020-03-02 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
355 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 21 | 17 | 45 | 64 | 19 | 160 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 4 | 3 | 24 | 18 | 13 | 61 |
| Psychotic disorders | D011618 | F20.81 | 2 | 3 | 8 | 26 | 11 | 49 | |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 1 | 1 | 13 | 12 | 3 | 30 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 3 | 7 | 2 | 2 | 14 |
| Tourette syndrome | D005879 | EFO_0004895 | F95.2 | — | — | 7 | 2 | 1 | 10 |
| Tic disorders | D013981 | F95 | — | 1 | 4 | 2 | 2 | 8 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | 1 | 2 | 3 | 6 |
| Depression | D003863 | F33.9 | — | 1 | 1 | 2 | 2 | 6 | |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 3 | 3 | 1 | — | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | — | 1 | — | 1 | 2 |
| Behavioral symptoms | D001526 | HP_0000708 | — | — | 2 | — | — | 2 | |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | 1 | — | — | 2 |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Drug therapy | D004358 | — | 1 | 1 | — | — | 1 | ||
| Postpartum depression | D019052 | EFO_0007453 | F53.0 | — | — | 1 | — | — | 1 |
| Body weight changes | D001836 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | 1 | — | — | 2 | 3 |
| Cocaine-related disorders | D019970 | F14 | 1 | 2 | — | — | — | 3 | |
| Asperger syndrome | D020817 | EFO_0003757 | F84.5 | — | 3 | — | — | — | 3 |
| Nervous system diseases | D009422 | G00-G99 | 1 | 1 | — | — | — | 2 | |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | 1 | 1 | — | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | — | 1 |
| Fragile x syndrome | D005600 | Q99.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | — | 4 | ||
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 2 | — | — | — | — | 2 |
| Immunoassay | D007118 | 1 | — | — | — | — | 1 | ||
| Amphetamine-related disorders | D019969 | EFO_0004701 | F15 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | — | 1 | 1 | ||
| Body weight | D001835 | EFO_0004338 | — | — | — | — | 1 | 1 | |
| Therapeutic equivalency | D013810 | — | — | — | — | 1 | 1 | ||
| Dissociative disorders | D004213 | F44.1 | — | — | — | — | 1 | 1 | |
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 1 | 1 | |
| Trichotillomania | D014256 | HP_0012167 | F63.3 | — | — | — | — | 1 | 1 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ARMODAFINIL |
| INN | armodafinil |
| 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 class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | NC(=O)C[S@@+]([O-])C(c1ccccc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 112111-43-0 |
| RxCUI | 641465 |
| ChEMBL ID | CHEMBL1201192 |
| ChEBI ID | 77590 |
| PubChem CID | 9690109 |
| DrugBank | DB06413 |
| UNII ID | V63XWA605I (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Nuvigil - Cephalon
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Additional graphs summarizing 807 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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72,770 adverse events reported
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