Stem definition | Drug id | CAS RN |
---|---|---|
2355 | 196597-26-9 |
None
Property | Value | Reference |
---|---|---|
BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
EoM (Fraction excreted unchanged in urine) | 0.10 % | Benet LZ, Broccatelli F, Oprea TI |
MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.44 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
BA (Bioavailability) | 1.80 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Vd (Volume of distribution) | 1.05 L/kg | Lombardo F, Berellini G, Obach RS |
CL (Clearance) | 13.10 mL/min/kg | Lombardo F, Berellini G, Obach RS |
fu (Fraction unbound in plasma) | 0.20 % | Lombardo F, Berellini G, Obach RS |
t_half (Half-life) | 1.90 hours | Lombardo F, Berellini G, Obach RS |
Date | Agency | Company | Orphan |
---|---|---|---|
July 22, 2005 | FDA | TAKEDA PHARMS USA |
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 |
---|---|---|---|---|---|---|
Initial insomnia | 127.71 | 17.48 | 38 | 5067 | 5117 | 53338844 |
Abnormal dreams | 126.86 | 17.48 | 45 | 5060 | 10556 | 53333405 |
Nightmare | 114.30 | 17.48 | 48 | 5057 | 17703 | 53326258 |
Middle insomnia | 107.76 | 17.48 | 40 | 5065 | 10668 | 53333293 |
Product dispensing error | 66.92 | 17.48 | 28 | 5077 | 10212 | 53333749 |
Somnolence | 66.58 | 17.48 | 81 | 5024 | 167653 | 53176308 |
Poor quality sleep | 61.53 | 17.48 | 31 | 5074 | 17292 | 53326669 |
Insomnia | 59.57 | 17.48 | 81 | 5024 | 186991 | 53156970 |
Altered state of consciousness | 36.26 | 17.48 | 25 | 5080 | 24811 | 53319150 |
Ovarian cancer recurrent | 35.10 | 17.48 | 10 | 5095 | 1153 | 53342808 |
Hallucination | 33.51 | 17.48 | 33 | 5072 | 53805 | 53290156 |
Hepatic function abnormal | 31.51 | 17.48 | 27 | 5078 | 36872 | 53307089 |
Somnambulism | 29.46 | 17.48 | 13 | 5092 | 5389 | 53338572 |
Intentional overdose | 29.12 | 17.48 | 34 | 5071 | 67171 | 53276790 |
Restlessness | 29.11 | 17.48 | 23 | 5082 | 28064 | 53315897 |
Galactorrhoea | 26.35 | 17.48 | 11 | 5094 | 3984 | 53339977 |
Hangover | 24.48 | 17.48 | 8 | 5097 | 1460 | 53342501 |
Feeling abnormal | 24.11 | 17.48 | 45 | 5060 | 135256 | 53208705 |
Hypersomnia | 22.78 | 17.48 | 16 | 5089 | 16339 | 53327622 |
Drug eruption | 22.73 | 17.48 | 19 | 5086 | 25075 | 53318886 |
Impulsive behaviour | 20.25 | 17.48 | 7 | 5098 | 1517 | 53342444 |
Blood pressure decreased | 19.94 | 17.48 | 27 | 5078 | 61842 | 53282119 |
Anxiety | 19.77 | 17.48 | 52 | 5053 | 196652 | 53147309 |
Hallucination, visual | 18.61 | 17.48 | 15 | 5090 | 18817 | 53325144 |
Interstitial lung disease | 18.01 | 17.48 | 25 | 5080 | 58597 | 53285364 |
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 |
---|---|---|---|---|---|---|
Somnolence | 67.33 | 18.87 | 70 | 3599 | 103727 | 32406130 |
Initial insomnia | 65.59 | 18.87 | 21 | 3648 | 3051 | 32506806 |
Hangover | 52.32 | 18.87 | 14 | 3655 | 1085 | 32508772 |
Middle insomnia | 50.28 | 18.87 | 21 | 3648 | 6463 | 32503394 |
Nightmare | 49.99 | 18.87 | 26 | 3643 | 13140 | 32496717 |
Abnormal dreams | 47.78 | 18.87 | 22 | 3647 | 8542 | 32501315 |
Pneumonia aspiration | 42.50 | 18.87 | 36 | 3633 | 41120 | 32468737 |
Interstitial lung disease | 37.05 | 18.87 | 41 | 3628 | 64960 | 32444897 |
Poor quality sleep | 36.65 | 18.87 | 18 | 3651 | 8056 | 32501801 |
Hepatic function abnormal | 34.05 | 18.87 | 33 | 3636 | 44807 | 32465050 |
Delirium | 30.81 | 18.87 | 31 | 3638 | 44015 | 32465842 |
Disseminated intravascular coagulation | 29.68 | 18.87 | 23 | 3646 | 23153 | 32486704 |
Cerebral infarction | 28.17 | 18.87 | 24 | 3645 | 27590 | 32482267 |
Upper respiratory tract inflammation | 24.60 | 18.87 | 9 | 3660 | 1948 | 32507909 |
Restlessness | 22.12 | 18.87 | 20 | 3649 | 24861 | 32484996 |
Insomnia | 19.43 | 18.87 | 38 | 3631 | 100310 | 32409547 |
Source | Code | Description |
---|---|---|
ATC | N05CH02 | NERVOUS SYSTEM PSYCHOLEPTICS HYPNOTICS AND SEDATIVES Melatonin receptor agonists |
FDA MoA | N0000000250 | Melatonin Receptor Agonists |
FDA EPC | N0000175743 | Melatonin Receptor Agonist |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Initial insomnia | indication | 59050008 | |
Suicidal thoughts | contraindication | 6471006 | |
Alcoholism | contraindication | 7200002 | |
Depressive disorder | contraindication | 35489007 | |
Hepatic failure | contraindication | 59927004 | |
Sleep apnea | contraindication | 73430006 | DOID:0050847 |
Disease of liver | contraindication | 235856003 | DOID:409 |
Hyperprolactinemia | contraindication | 237662005 | DOID:12700 |
Sleep automatism | contraindication | 247962006 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 13.14 | acidic |
None
None
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Melatonin receptor type 1A | GPCR | AGONIST | Ki | 10.90 | WOMBAT-PK | CHEMBL | |||
Melatonin receptor type 1B | GPCR | AGONIST | Ki | 10.39 | WOMBAT-PK | CHEMBL |
ID | Source |
---|---|
4024923 | VUID |
N0000171613 | NUI |
D02689 | KEGG_DRUG |
4024923 | VANDF |
C1565316 | UMLSCUI |
CHEBI:109549 | CHEBI |
JEV | PDB_CHEM_ID |
CHEMBL1218 | ChEMBL_ID |
DB00980 | DRUGBANK_ID |
8447 | INN_ID |
C495910 | MESH_SUPPLEMENTAL_RECORD_UI |
208902 | PUBCHEM_CID |
1356 | IUPHAR_LIGAND_ID |
901AS54I69 | UNII |
596205 | RXNORM |
20324 | MMSL |
320752 | MMSL |
70325 | MMSL |
d05578 | MMSL |
010947 | NDDF |
419588002 | SNOMEDCT_US |
419878007 | SNOMEDCT_US |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2191 | TABLET | 8 mg | ORAL | ANDA | 27 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0832-1250 | TABLET, FILM COATED | 8 mg | ORAL | ANDA | 30 sections |
Rozerem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-183 | TABLET, FILM COATED | 8 mg | ORAL | NDA | 30 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-776 | TABLET | 8 mg | ORAL | ANDA | 26 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43598-741 | TABLET | 8 mg | ORAL | ANDA | 25 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-708 | TABLET | 8 mg | ORAL | ANDA | 26 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51407-375 | TABLET | 8 mg | ORAL | ANDA | 26 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52817-235 | TABLET, FILM COATED | 8 mg | ORAL | ANDA | 28 sections |
Rozerem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5649 | TABLET, FILM COATED | 8 mg | ORAL | NDA | 18 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55700-874 | TABLET, FILM COATED | 8 mg | ORAL | ANDA | 28 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-8264 | TABLET | 8 mg | ORAL | ANDA | 28 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-8531 | TABLET | 8 mg | ORAL | ANDA | 26 sections |
Rozerem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 64764-805 | TABLET, FILM COATED | 8 mg | ORAL | NDA | 27 sections |
Rozerem | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68151-4881 | TABLET, FILM COATED | 8 mg | ORAL | NDA | 28 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70010-028 | TABLET | 8 mg | ORAL | ANDA | 26 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1344 | TABLET | 8 mg | ORAL | ANDA | 27 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70771-1495 | TABLET | 8 mg | ORAL | ANDA | 1 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71205-918 | TABLET | 8 mg | ORAL | ANDA | 26 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71335-1853 | TABLET | 8 mg | ORAL | ANDA | 27 sections |
RAMELTEON | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72189-153 | TABLET | 8 mg | ORAL | ANDA | 16 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72319-005 | TABLET, FILM COATED | 8 mg | ORAL | ANDA | 28 sections |