Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C15H19NO2 |
Molecular Weight | 245.3169 |
Optical Activity | UNSPECIFIED |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
CCC(=O)NC[C@@H]1C[C@H]1C2=C3CCOC3=CC=C2
InChI
InChIKey=PTOIAAWZLUQTIO-GXFFZTMASA-N
InChI=1S/C15H19NO2/c1-2-15(17)16-9-10-8-13(10)11-4-3-5-14-12(11)6-7-18-14/h3-5,10,13H,2,6-9H2,1H3,(H,16,17)/t10-,13+/m0/s1
Molecular Formula | C15H19NO2 |
Molecular Weight | 245.3169 |
Charge | 0 |
Count |
|
Stereochemistry | ABSOLUTE |
Additional Stereochemistry | No |
Defined Stereocenters | 2 / 2 |
E/Z Centers | 0 |
Optical Activity | UNSPECIFIED |
DescriptionCurator's Comment: description was created based on several sources, including
http://www.ncbi.nlm.nih.gov/pubmed/?term=19579175
Curator's Comment: description was created based on several sources, including
http://www.ncbi.nlm.nih.gov/pubmed/?term=19579175
Tasimelteon, developed by Vanda Pharmaceuticals Inc under license from Bristol-Myers Squibb Co, is a melatonin receptor agonist. Tasimelteon differs structurally from melatonin and drugs with known melatonin agonist activity, in particular by its distinct aromatic group and linker. Tasimelteon bears also no structural relationship to any other approved active substance. Tasimelteon is presumably acts through activation of MT1 and MT2 G-protein coupled receptors, which are involved primarily in inhibition of neuronal firing and phase shift of circadian rhythms. Tasimelteon is approved for the treatment of Non24-Hour Sleep-Wake Disorder.
Originator
Sources: https://newdrugapprovals.org/tag/tasimelteon/
Curator's Comment: In May 2013 Vanda Pharmaceuticals submitted a New Drug Application to the Food and Drug Administration for Tasimelteon
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: P49286 Gene ID: 4544.0 Gene Symbol: MTNR1B Target Organism: Homo sapiens (Human) |
0.0692 nM [Ki] | ||
Target ID: P48039 Gene ID: 4543.0 Gene Symbol: MTNR1A Target Organism: Homo sapiens (Human) |
0.304 nM [Ki] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | HETLIOZ Approved UseIndicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). Launch Date2014 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
12 ng/mL |
1 mg 1 times / day steady-state, oral dose: 1 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
394 ng/mL |
150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
873 ng/mL |
150 mg 1 times / day steady-state, oral dose: 150 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
173 ng/mL |
50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
33 ng/mL |
10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
261 ng/mL |
50 mg 1 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
5 ng/mL |
1 mg single, oral dose: 1 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
51 ng/mL |
10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
786 ng/mL |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
445 ng/mL |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: HIGH-FAT |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
17 ng × h/mL |
1 mg 1 times / day steady-state, oral dose: 1 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
1823 ng × h/mL |
150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
3797 ng × h/mL |
150 mg 1 times / day steady-state, oral dose: 150 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
426 ng × h/mL |
50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
59 ng × h/mL |
10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
611 ng × h/mL |
50 mg 1 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
8 ng × h/mL |
1 mg single, oral dose: 1 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
96 ng × h/mL |
10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
2269 ng × h/mL |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
2304 ng × h/mL |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: HIGH-FAT |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
1.49 h |
1 mg 1 times / day steady-state, oral dose: 1 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
2.78 h |
150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
2.63 h |
150 mg 1 times / day steady-state, oral dose: 150 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
2.37 h |
50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
1.29 h |
10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
2.57 h |
50 mg 1 times / day steady-state, oral dose: 50 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
1.75 h |
1 mg single, oral dose: 1 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
1.44 h |
10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
2.75 h |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
|
2.06 h |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
TASIMELTEON plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: HIGH-FAT |
Doses
Dose | Population | Adverse events |
---|---|---|
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Disc. AE: Supraventricular extrasystoles, Tachycardia... AEs leading to discontinuation/dose reduction: Supraventricular extrasystoles (0.07%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81Tachycardia (0.07%) Constipation (0.07%) Fatigue (0.07%) Oedema peripheral (0.07%) Cholestasis (0.07%) ALT increased (0.07%) AST increased (0.07%) GGT increased (0.07%) Blood creatine increased (0.07%) Hyperglycaemia (0.07%) Headache (0.07%) Loss of consciousness (0.07%) Syncope (0.07%) Transient ischaemic attack (0.07%) Insomnia (0.14%) Nightmare (0.14%) Renal pain (0.07%) Rash (0.07%) |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Disc. AE: Supraventricular extrasystoles, Vomiting... AEs leading to discontinuation/dose reduction: Supraventricular extrasystoles (0.7%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84Vomiting (0.7%) Headache (0.7%) Syncope (0.7%) Insomnia (0.7%) Nightmare (1.3%) Anger (0.7%) Depression (0.7%) |
1 mg 1 times / day multiple, oral Studied dose Dose: 1 mg, 1 times / day Route: oral Route: multiple Dose: 1 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Disc. AE: Local swelling, Disorientation... AEs leading to discontinuation/dose reduction: Local swelling (0.07%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81Disorientation (0.07%) Rash (0.07%) |
10 mg 1 times / day multiple, oral Studied dose Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Disc. AE: Diarrhoea, Gastritis... AEs leading to discontinuation/dose reduction: Diarrhoea (0.07%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81Gastritis (0.07%) Dizziness (0.07%) |
100 mg 1 times / day multiple, oral Studied dose Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Disc. AE: Vomiting... AEs leading to discontinuation/dose reduction: Vomiting (0.07%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
150 mg 1 times / day multiple, oral Studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Disc. AE: Rash... AEs leading to discontinuation/dose reduction: Rash (0.07%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Disc. AE: Ventricular arrhythmia, Gastritis... AEs leading to discontinuation/dose reduction: Ventricular arrhythmia (0.9%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84Gastritis (0.9%) Local swelling (0.9%) Electrocardiogram ST segment elevation (0.9%) Ataxia (0.9%) Dizziness (0.9%) Confusional state (0.9%) Disorientation (0.9%) Rash (0.9%) |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Disc. AE: Supraventricular extrasystoles, Ventricular arrhythmia... AEs leading to discontinuation/dose reduction: Supraventricular extrasystoles (0.2%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84Ventricular arrhythmia (0.2%) Diarrhoea (0.2%) Dyspepsia (0.2%) Gastritis (0.2%) Hypoaesthesia oral (0.2%) Vomiting (0.2%) Local swelling (0.2%) Somnolence (0.5%) Ataxia (0.2%) Dizziness (0.2%) Headache (0.2%) Syncope (0.2%) Insomnia (0.5%) Nightmare (0.5%) Anger (0.2%) Confusional state (0.2%) Depression (0.2%) Disorientation (0.2%) Rash (0.2%) |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Disc. AE: Dyspepsia, Blood creatine increased... AEs leading to discontinuation/dose reduction: Dyspepsia (0.07%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81Blood creatine increased (0.07%) Somnolence (0.07%) Insomnia (0.07%) |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 164 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 164 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Disc. AE: Diarrhoea, Dyspepsia... AEs leading to discontinuation/dose reduction: Diarrhoea (0.6%) Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84Dyspepsia (0.6%) Hypoaesthesia oral (0.6%) Blood creatine phosphokinase increased (0.6%) Somnolence (1.2%) Insomnia (0.6%) |
300 mg 1 times / day multiple, oral Highest studied dose Dose: 300 mg, 1 times / day Route: oral Route: multiple Dose: 300 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.20 |
healthy, 18-44 years n = 11 Health Status: healthy Age Group: 18-44 years Sex: M+F Population Size: 11 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.20 |
Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.20 |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
ALT increased | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
AST increased | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Blood creatine increased | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Cholestasis | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Constipation | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Fatigue | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
GGT increased | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Headache | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Hyperglycaemia | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Loss of consciousness | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Oedema peripheral | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Rash | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Renal pain | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Supraventricular extrasystoles | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Syncope | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Tachycardia | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Transient ischaemic attack | 0.07% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Insomnia | 0.14% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Nightmare | 0.14% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Anger | 0.7% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Depression | 0.7% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Headache | 0.7% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Insomnia | 0.7% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Supraventricular extrasystoles | 0.7% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Syncope | 0.7% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Vomiting | 0.7% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Nightmare | 1.3% Disc. AE |
20 mg 1 times / day multiple, oral Recommended Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 151 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 151 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Disorientation | 0.07% Disc. AE |
1 mg 1 times / day multiple, oral Studied dose Dose: 1 mg, 1 times / day Route: oral Route: multiple Dose: 1 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Local swelling | 0.07% Disc. AE |
1 mg 1 times / day multiple, oral Studied dose Dose: 1 mg, 1 times / day Route: oral Route: multiple Dose: 1 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Rash | 0.07% Disc. AE |
1 mg 1 times / day multiple, oral Studied dose Dose: 1 mg, 1 times / day Route: oral Route: multiple Dose: 1 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Diarrhoea | 0.07% Disc. AE |
10 mg 1 times / day multiple, oral Studied dose Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Dizziness | 0.07% Disc. AE |
10 mg 1 times / day multiple, oral Studied dose Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Gastritis | 0.07% Disc. AE |
10 mg 1 times / day multiple, oral Studied dose Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Vomiting | 0.07% Disc. AE |
100 mg 1 times / day multiple, oral Studied dose Dose: 100 mg, 1 times / day Route: oral Route: multiple Dose: 100 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Rash | 0.07% Disc. AE |
150 mg 1 times / day multiple, oral Studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Ataxia | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Confusional state | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Disorientation | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Dizziness | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Electrocardiogram ST segment elevation | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Gastritis | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Local swelling | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Rash | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Ventricular arrhythmia | 0.9% Disc. AE |
20 mg 1 times / day multiple, oral (max) Studied dose Dose: 20 mg, 1 times / day Route: oral Route: multiple Dose: 20 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 114 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 114 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Anger | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Ataxia | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Confusional state | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Depression | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Diarrhoea | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Disorientation | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Dizziness | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Dyspepsia | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Gastritis | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Headache | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Hypoaesthesia oral | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Local swelling | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Rash | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Supraventricular extrasystoles | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Syncope | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Ventricular arrhythmia | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Vomiting | 0.2% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Insomnia | 0.5% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Nightmare | 0.5% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Somnolence | 0.5% Disc. AE |
25 mg 1 times / day multiple, oral (mean) Studied dose Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 429 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 429 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Blood creatine increased | 0.07% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Dyspepsia | 0.07% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Insomnia | 0.07% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Somnolence | 0.07% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
unhealthy, 18 - 92 years n = 1346 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 1346 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.81 |
Blood creatine phosphokinase increased | 0.6% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 164 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 164 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Diarrhoea | 0.6% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 164 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 164 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Dyspepsia | 0.6% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 164 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 164 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Hypoaesthesia oral | 0.6% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 164 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 164 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Insomnia | 0.6% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 164 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 164 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Somnolence | 1.2% Disc. AE |
50 mg 1 times / day multiple, oral Studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
unhealthy, 18 - 92 years n = 164 Health Status: unhealthy Condition: 24-Hour Sleep-Wake Disorder Age Group: 18 - 92 years Sex: M+F Population Size: 164 Sources: Page: nda/2014/205677Orig1s000MedR.pdf - p.84 |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
no | ||||
no | ||||
no | ||||
no | ||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=8 Page: 8.0 |
no | |||
no | ||||
no | ||||
no | ||||
no | ||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=8 Page: 8.0 |
no | |||
no | ||||
no | ||||
no | ||||
no | ||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=8 Page: 8.0 |
no | |||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=8 Page: 8.0 |
no | |||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=8 Page: 8.0 |
yes | yes (co-administration study) Comment: Rifampin, a strong CYP3A4 and moderate CYP2C8, CYP2C9/2C19 inducer, decreased the exposure of tasimelteon by approximately 90%. Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=8 Page: 8.0 |
||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=8 Page: 8.0 |
yes | yes (co-administration study) Comment: Rifampin, a strong CYP3A4 and moderate CYP2C8, CYP2C9/2C19 inducer, decreased the exposure of tasimelteon by approximately 90%. Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=8 Page: 8.0 |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
major | yes (co-administration study) Comment: Drug interaction studies with CY1A2 inhibitor, fluvoxamine and CYP3A4 inducer, rifampin resulted in 6.5 fold increase and 90% decrease in tasimelteon exposure respectively. Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=5 Page: 5.0 |
|||
major | yes (co-administration study) Comment: Drug interaction studies with CY1A2 inhibitor, fluvoxamine and CYP3A4 inducer, rifampin resulted in 6.5 fold increase and 90% decrease in tasimelteon exposure respectively. Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000ClinPharmR.pdf#page=5 Page: 5.0 |
|||
minor | ||||
minor | ||||
minor | ||||
minor | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205677Orig1s000PharmR.pdf#page=28 Page: 28.0 |
PubMed
Title | Date | PubMed |
---|---|---|
Tasimelteon, a melatonin agonist for the treatment of insomnia and circadian rhythm sleep disorders. | 2009 Jul |
|
Sleep-promoting action of IIK7, a selective MT2 melatonin receptor agonist in the rat. | 2009 Jun 26 |
|
Jet lag, circadian rhythm sleep disturbances, and depression: the role of melatonin and its analogs. | 2010 Nov |
|
Mechanism of action of tasimelteon in non-24 sleep-wake syndrome: treatment for a circadian rhythm disorder in blind patients. | 2014 Dec |
|
Tasimelteon: a selective and unique receptor binding profile. | 2015 Apr |
|
Tasimelteon for the treatment of non-24-hour sleep-wake disorder. | 2015 Jan |
Patents
Sample Use Guides
Substance Class |
Chemical
Created
by
admin
on
Edited
Fri Dec 15 15:58:06 GMT 2023
by
admin
on
Fri Dec 15 15:58:06 GMT 2023
|
Record UNII |
SHS4PU80D9
|
Record Status |
Validated (UNII)
|
Record Version |
|
-
Download
Name | Type | Language | ||
---|---|---|---|---|
|
Official Name | English | ||
|
Common Name | English | ||
|
Brand Name | English | ||
|
Common Name | English | ||
|
Systematic Name | English | ||
|
Code | English | ||
|
Code | English | ||
|
Code | English | ||
|
Brand Name | English | ||
|
Systematic Name | English | ||
|
Common Name | English | ||
|
Common Name | English | ||
|
Common Name | English | ||
|
Common Name | English | ||
|
Common Name | English |
Classification Tree | Code System | Code | ||
---|---|---|---|---|
|
WHO-ATC |
N05CH03
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
||
|
NDF-RT |
N0000175743
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
||
|
FDA ORPHAN DRUG |
297409
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
||
|
EU-Orphan Drug |
EU/3/10/841
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
||
|
EMA ASSESSMENT REPORTS |
HETLIOZ (AUTHORIZED: SLEEP DISORDERS, CICARDIAN RHYTHM)
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
||
|
NCI_THESAURUS |
C47795
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
||
|
FDA ORPHAN DRUG |
301410
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
Code System | Code | Type | Description | ||
---|---|---|---|---|---|
|
SS-70
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
SHS4PU80D9
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
SHS4PU80D9
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
10220503
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
609799-22-6
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
7393
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
DTXSID70209826
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
79042
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
1490468
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | RxNorm | ||
|
C152515
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
100000157714
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
4820
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
m10478
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | Merck Index | ||
|
8985
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
SUB166225
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
CHEMBL2103822
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
DB09071
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
TASIMELTEON
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY | |||
|
C478745
Created by
admin on Fri Dec 15 15:58:06 GMT 2023 , Edited by admin on Fri Dec 15 15:58:06 GMT 2023
|
PRIMARY |
Related Record | Type | Details | ||
---|---|---|---|---|
|
METABOLIC ENZYME -> SUBSTRATE |
MINOR
|
||
|
EXCRETED UNCHANGED |
FECAL
|
||
|
TARGET -> AGONIST | |||
|
METABOLIC ENZYME -> SUBSTRATE |
MAJOR
|
||
|
BINDER->LIGAND |
BINDING
|
||
|
EXCRETED UNCHANGED |
URINE
|
||
|
METABOLIC ENZYME -> SUBSTRATE |
MINOR
|
||
|
METABOLIC ENZYME -> SUBSTRATE |
MAJOR
|
||
|
TARGET -> AGONIST | |||
|
METABOLIC ENZYME -> SUBSTRATE |
MINOR
|
||
|
METABOLIC ENZYME -> SUBSTRATE |
MINOR
|
Related Record | Type | Details | ||
---|---|---|---|---|
|
METABOLITE INACTIVE -> PARENT |
MAJOR
|
||
|
METABOLITE -> PARENT | |||
|
METABOLITE -> PARENT | |||
|
METABOLITE -> PARENT | |||
|
METABOLITE -> PARENT |
Related Record | Type | Details | ||
---|---|---|---|---|
|
ACTIVE MOIETY |
Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
---|---|---|---|---|---|---|
Tmax | PHARMACOKINETIC |
|
SINGLE- OR MULTIPLE-DOSE ADMINISTRATION |
|
||
Volume of Distribution | PHARMACOKINETIC |
|
|
|||
Biological Half-life | PHARMACOKINETIC |
|
|
|||