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 ยตM/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 |
---|---|---|---|---|---|---|
Abnormal dreams | 129.89 | 17.28 | 45 | 5065 | 9332 | 50590682 |
Initial insomnia | 121.70 | 17.28 | 37 | 5073 | 5078 | 50594936 |
Nightmare | 116.37 | 17.28 | 48 | 5062 | 16038 | 50583976 |
Middle insomnia | 108.63 | 17.28 | 40 | 5070 | 9881 | 50590133 |
Somnolence | 69.90 | 17.28 | 82 | 5028 | 154903 | 50445111 |
Product dispensing error | 69.29 | 17.28 | 28 | 5082 | 8863 | 50591151 |
Poor quality sleep | 61.12 | 17.28 | 31 | 5079 | 16615 | 50583399 |
Altered state of consciousness | 37.88 | 17.28 | 25 | 5085 | 21885 | 50578129 |
Ovarian cancer recurrent | 37.31 | 17.28 | 10 | 5100 | 872 | 50599142 |
Hallucination | 36.03 | 17.28 | 33 | 5077 | 46624 | 50553390 |
Hepatic function abnormal | 35.23 | 17.28 | 28 | 5082 | 32653 | 50567361 |
Restlessness | 30.24 | 17.28 | 23 | 5087 | 25150 | 50574864 |
Somnambulism | 29.94 | 17.28 | 13 | 5097 | 4911 | 50595103 |
Intentional overdose | 29.64 | 17.28 | 34 | 5076 | 62470 | 50537544 |
Galactorrhoea | 26.53 | 17.28 | 11 | 5099 | 3712 | 50596302 |
Feeling abnormal | 24.80 | 17.28 | 45 | 5065 | 125447 | 50474567 |
Hangover | 24.50 | 17.28 | 8 | 5102 | 1381 | 50598633 |
Hypersomnia | 22.95 | 17.28 | 16 | 5094 | 15298 | 50584716 |
Drug eruption | 22.85 | 17.28 | 19 | 5091 | 23587 | 50576427 |
Blood pressure decreased | 22.53 | 17.28 | 28 | 5082 | 55881 | 50544133 |
Anxiety | 20.34 | 17.28 | 51 | 5059 | 177555 | 50422459 |
Impulsive behaviour | 20.18 | 17.28 | 7 | 5103 | 1451 | 50598563 |
Hallucination, visual | 19.58 | 17.28 | 15 | 5095 | 16567 | 50583447 |
Interstitial lung disease | 18.86 | 17.28 | 25 | 5085 | 53151 | 50546863 |
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 | 66.91 | 17.69 | 70 | 3643 | 93885 | 29476929 |
Initial insomnia | 65.48 | 17.69 | 21 | 3692 | 2754 | 29568060 |
Hangover | 52.47 | 17.69 | 14 | 3699 | 963 | 29569851 |
Nightmare | 50.87 | 17.69 | 26 | 3687 | 11391 | 29559423 |
Middle insomnia | 50.70 | 17.69 | 21 | 3692 | 5687 | 29565127 |
Abnormal dreams | 50.03 | 17.69 | 22 | 3691 | 6898 | 29563916 |
Pneumonia aspiration | 46.90 | 17.69 | 38 | 3675 | 36699 | 29534115 |
Interstitial lung disease | 37.46 | 17.69 | 41 | 3672 | 57677 | 29513137 |
Hepatic function abnormal | 34.78 | 17.69 | 33 | 3680 | 39226 | 29531588 |
Poor quality sleep | 33.75 | 17.69 | 17 | 3696 | 7216 | 29563598 |
Disseminated intravascular coagulation | 30.53 | 17.69 | 23 | 3690 | 19957 | 29550857 |
Delirium | 29.11 | 17.69 | 30 | 3683 | 39367 | 29531447 |
Cerebral infarction | 28.29 | 17.69 | 24 | 3689 | 24651 | 29546163 |
Upper respiratory tract inflammation | 25.32 | 17.69 | 9 | 3704 | 1611 | 29569203 |
Restlessness | 20.33 | 17.69 | 19 | 3694 | 22126 | 29548688 |
Enterocolitis | 18.19 | 17.69 | 11 | 3702 | 6655 | 29564159 |
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 | 104.99 | 15.77 | 35 | 7242 | 5769 | 64485686 |
Middle insomnia | 84.32 | 15.77 | 37 | 7240 | 12840 | 64478615 |
Somnolence | 73.44 | 15.77 | 102 | 7175 | 203543 | 64287912 |
Hepatic function abnormal | 65.86 | 15.77 | 56 | 7221 | 64257 | 64427198 |
Poor quality sleep | 65.05 | 15.77 | 35 | 7242 | 18916 | 64472539 |
Pneumonia aspiration | 63.55 | 15.77 | 53 | 7224 | 59218 | 64432237 |
Abnormal dreams | 59 | 15.77 | 27 | 7250 | 10329 | 64481126 |
Hangover | 53.23 | 15.77 | 16 | 7261 | 1885 | 64489570 |
Interstitial lung disease | 51.14 | 15.77 | 59 | 7218 | 97673 | 64393782 |
Altered state of consciousness | 49.37 | 15.77 | 38 | 7239 | 37864 | 64453591 |
Nightmare | 48.59 | 15.77 | 30 | 7247 | 20963 | 64470492 |
Delirium | 41.73 | 15.77 | 45 | 7232 | 69149 | 64422306 |
Restlessness | 41.44 | 15.77 | 35 | 7242 | 39750 | 64451705 |
Disseminated intravascular coagulation | 34.80 | 15.77 | 29 | 7248 | 32319 | 64459136 |
Cerebral infarction | 32.62 | 15.77 | 31 | 7246 | 41013 | 64450442 |
Drug eruption | 30.07 | 15.77 | 28 | 7249 | 36108 | 64455347 |
Femoral neck fracture | 29.62 | 15.77 | 16 | 7261 | 8708 | 64482747 |
Intentional overdose | 26.46 | 15.77 | 41 | 7236 | 89903 | 64401552 |
Hypersomnia | 26.17 | 15.77 | 20 | 7257 | 19697 | 64471758 |
Upper respiratory tract inflammation | 25.18 | 15.77 | 11 | 7266 | 3771 | 64487684 |
Marasmus | 22.99 | 15.77 | 7 | 7270 | 861 | 64490594 |
Renal impairment | 21.26 | 15.77 | 47 | 7230 | 134970 | 64356485 |
Arthralgia | 20.90 | 15.77 | 12 | 7265 | 442248 | 64049207 |
Product administered to patient of inappropriate age | 20.11 | 15.77 | 10 | 7267 | 4591 | 64486864 |
Hallucination | 19.78 | 15.77 | 32 | 7245 | 72756 | 64418699 |
Platelet count decreased | 19.57 | 15.77 | 52 | 7225 | 167659 | 64323796 |
Blood pressure decreased | 18.32 | 15.77 | 34 | 7243 | 86165 | 64405290 |
Hallucination, visual | 16.58 | 15.77 | 18 | 7259 | 27816 | 64463639 |
Respiratory failure | 15.87 | 15.77 | 47 | 7230 | 161136 | 64330319 |
None
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 |
None
None
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 |
C495910 | MESH_SUPPLEMENTAL_RECORD_UI |
208902 | PUBCHEM_CID |
1356 | IUPHAR_LIGAND_ID |
8447 | INN_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 | 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 | 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 | 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 | 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 | 63629-8264 | TABLET | 8 mg | ORAL | ANDA | 28 sections |
Ramelteon | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63629-8531 | TABLET | 8 mg | ORAL | ANDA | 26 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 | 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 |