Scroll

armodafinil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	4501	112111-43-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: nuvigil CEP-10953 armodafinil R-modafinil	Molecular weight: 273.35 Formula: C15H15NO2S CLOGP: 0.94 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 60.16 ALOGS: -2.64 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

nuvigil
CEP-10953
armodafinil
R-modafinil

Molecular weight: 273.35
Formula: C15H15NO2S
CLOGP: 0.94
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 60.16
ALOGS: -2.64
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.15	g	O

ADMET properties:

Show entries

Search:

Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	8 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	13.06 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Showing 1 to 3 of 3 entries

Previous1Next

Approvals:

Date	Agency	Company	Orphan
June 5, 2007	FDA	CEPHALON

FDA Adverse Event Reporting System (Female)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pre-existing condition improved	262.71	15.18	91	14631	8153	63466147
Anxiety	224.95	15.18	264	14458	217277	63257023
Sleep apnoea syndrome	223.83	15.18	117	14605	29016	63445284
Depression	187.46	15.18	229	14493	196263	63278037
Suicidal ideation	174.72	15.18	132	14590	62289	63412011
Product administration interrupted	122.33	15.18	45	14677	4791	63469509
Somnambulism	112.81	15.18	44	14678	5499	63468801
Therapeutic response unexpected	112.55	15.18	64	14658	18695	63455605
Feeling abnormal	87.05	15.18	137	14585	148255	63326045
Multiple sclerosis relapse	71.22	15.18	71	14651	48407	63425893

Showing 1 to 10 of 101 entries

Previous1 2 3 4 5…11Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Sleep apnoea syndrome	154.47	23.31	68	4582	20253	34932028
Depression	81.13	23.31	81	4569	97017	34855264
Suicidal ideation	78.57	23.31	55	4595	40333	34911948
Pre-existing condition improved	78.23	23.31	24	4626	2568	34949713
Anxiety	68.79	23.31	75	4575	99353	34852928
Product administration interrupted	59.88	23.31	18	4632	1797	34950484
Somnambulism	50.58	23.31	18	4632	3054	34949227
Insomnia	48.18	23.31	64	4586	103843	34848438
Feeling abnormal	39.02	23.31	45	4605	63190	34889091
Therapeutic response unexpected	38.80	23.31	21	4629	9736	34942545

Showing 1 to 10 of 21 entries

Previous1 2 3Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pre-existing condition improved	115.64	16.44	39	10790	5524	79728035
Sleep apnoea syndrome	115.26	16.44	68	10761	36410	79697149
Anxiety	112.68	16.44	153	10676	248359	79485200
Depression	100.55	16.44	135	10694	216655	79516904
Multiple sclerosis relapse	95.33	16.44	66	10763	46467	79687092
Feeling abnormal	87.69	16.44	108	10721	159091	79574468
Somnambulism	69.61	16.44	27	10802	5694	79727865
Suicidal ideation	63.00	16.44	64	10765	76276	79657283
Somnolence	60.73	16.44	113	10716	238868	79494691
Memory impairment	58.59	16.44	74	10755	111660	79621899

Showing 1 to 10 of 63 entries

Previous1 2 3 4 5 6 7Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	N06BA13	NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics
CHEBI has role	CHEBI:35337	analeptic
CHEBI has role	CHEBI:77567	wakefulness-promoting agent
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D000697	Central Nervous System Stimulants
MeSH PA	D065701	Cytochrome P-450 CYP3A Inducers
MeSH PA	D065606	Metabolic Side Effects of Drugs and Substances
MeSH PA	D064690	Wakefulness-Promoting Agents

Showing 1 to 8 of 8 entries

Previous1Next

Drug Use | Suggest Off label Use Form| |View source of the data|

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Narcolepsy	indication	60380001	DOID:8986
Sleepiness Due To Obstructive Sleep Apnea	indication
Sleepiness Due To Shift Work Sleep Disorder	indication
Suicidal thoughts	contraindication	6471006
Depressive disorder	contraindication	35489007
Hypertensive disorder	contraindication	38341003	DOID:10763
Left ventricular hypertrophy	contraindication	55827005
Hepatic failure	contraindication	59927004
Psychotic disorder	contraindication	69322001
Mania	contraindication	231494001

Showing 1 to 10 of 11 entries

Previous1 2Next

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.23	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN	INHIBITOR	IC50	5.50	WOMBAT-PK	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	4.41	CHEMBL
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		EC50	6.92	WOMBAT-PK
Cytochrome P450 1A2	Enzyme	P05177	CP1A2_HUMAN				WOMBAT-PK
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN				WOMBAT-PK
Alpha-1B adrenergic receptor	GPCR	P35368	ADA1B_HUMAN				WOMBAT-PK
Sodium-dependent dopamine transporter	Transporter		SC6A3_RAT		Ki	5.49	CHEMBL

Showing 1 to 7 of 7 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
012231	NDDF
116668	MMSL
23941	MMSL
241076	MMSL
4026237	VANDF
428694009	SNOMEDCT_US
429452005	SNOMEDCT_US
641465	RXNORM
8474	INN_ID
9690109	PUBCHEM_CID

Showing 1 to 10 of 18 entries

Previous1 2Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3090	TABLET	50 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3090	TABLET	50 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3090	TABLET	50 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3092	TABLET	150 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3092	TABLET	150 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3092	TABLET	150 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3093	TABLET	200 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3093	TABLET	200 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3093	TABLET	200 mg	ORAL	NDA authorized generic	30 sections
Armodafinil	HUMAN PRESCRIPTION DRUG LABEL	1	0093-3094	TABLET	250 mg	ORAL	NDA authorized generic	30 sections

Showing 1 to 10 of 30 entries

Previous1 2 3Next