Details
Stereochemistry | ABSOLUTE |
Molecular Formula | C10H14N2O2 |
Molecular Weight | 194.2304 |
Optical Activity | ( + ) |
Defined Stereocenters | 1 / 1 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
N[C@@H](COC(N)=O)CC1=CC=CC=C1
InChI
InChIKey=UCTRAOBQFUDCSR-SECBINFHSA-N
InChI=1S/C10H14N2O2/c11-9(7-14-10(12)13)6-8-4-2-1-3-5-8/h1-5,9H,6-7,11H2,(H2,12,13)/t9-/m1/s1
ADX-N05, originally discovered by SK Holdings, is a selective dopamine and norepinephrine reuptake inhibitor (DNRI). ADX-N05 (Solriamfetol, sold under the brand name Sunosi) is approved in the US and is under regulatory review in the EU to improve wakefulness in adult patients with hypersomnia associated with narcolepsy or obstructive sleep apnoea.The US FDA has approved solriamfetol (Sunosi, Jazz Pharmaceuticals) for the treatment of excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.The dual-acting dopamine and norepinephrine reuptake inhibitor is approved for narcolepsy in once-daily 75 mg and 150 mg doses, and in obstructive sleep apnea in once-daily 37.5 mg, 75 mg, and 150 mg doses.
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL238 Sources: https://www.ncbi.nlm.nih.gov/pubmed/29891587 |
2.9 µM [IC50] | ||
Target ID: CHEMBL222 Sources: https://www.ncbi.nlm.nih.gov/pubmed/29891587 |
4.4 µM [IC50] |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
499 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/30865315/ |
75 mg single, oral dose: 75 mg route of administration: Oral experiment type: SINGLE co-administered: |
SOLRIAMFETOL plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
5273 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/30865315/ |
75 mg single, oral dose: 75 mg route of administration: Oral experiment type: SINGLE co-administered: |
SOLRIAMFETOL plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
7.6 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/30865315/ |
75 mg single, oral dose: 75 mg route of administration: Oral experiment type: SINGLE co-administered: |
SOLRIAMFETOL plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED |
Doses
Dose | Population | Adverse events |
---|---|---|
112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Other AEs: Decreased appetite, Insomnia... Other AEs: Decreased appetite (9%) Sources: Insomnia (5%) Anxiety (6%) Headache (16%) Palpitations (2%) Nausea (7%) Dry mouth (4%) Constipation (3%) Agitation (<2%) Bruxism (<2%) Irritability (<2%) Cough (<2%) Hyperhidrosis (<2%) Feeling jittery (<2%) Thirst (<2%) Chest discomfort (<2%) Chest pain (<2%) Weight decreased (<2%) |
150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Disc. AE: Anxiety, Palpitations... Other AEs: Headache, Nausea... AEs leading to discontinuation/dose reduction: Anxiety (0.5%) Other AEs:Palpitations (0.5%) Restlessness (0.5%) Headache (13%) Sources: Nausea (9%) Decreased appetite (8%) Anxiety (7%) Dry mouth (4%) Diarrhea (5%) |
37.5 mg 1 times / day steady, oral (mean) Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: steady Dose: 37.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 58 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 58 Sources: |
Other AEs: Headache, Nausea... Other AEs: Headache (7%) Sources: Nausea (7%) Decreased appetite (2%) Anxiety (2%) Dry mouth (2%) Diarrhea (2%) |
75 mg 1 times / day steady, oral (mean) Recommended Dose: 75 mg, 1 times / day Route: oral Route: steady Dose: 75 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 120 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 120 Sources: |
Other AEs: Headache, Nausea... Other AEs: Headache (9%) Sources: Nausea (5%) Decreased appetite (7%) Anxiety (3%) Dry mouth (3%) Diarrhea (4%) |
87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Other AEs: Decreased appetite, Anxiety... Other AEs: Decreased appetite (6%) Sources: Anxiety (4%) Irritability (3%) Dizziness (2%) Palpitations (3%) Nausea (8%) Diarrhea (4%) Abdominal pain (3%) Dry mouth (3%) Feeling jittery (3%) Chest discomfort (2%) Hyperhidrosis (2%) Bruxism (<2%) Restlessness (<2%) Disturbance in attention (<2%) Tremor (<2%) Cough (<2%) Dyspnea (<2%) Constipation (<2%) Vomiting (<2%) Weight decreased (<2%) |
87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 396 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 396 Sources: |
Other AEs: Blood pressure systolic increased, Blood pressure diastolic increased... Other AEs: Blood pressure systolic increased Sources: Blood pressure diastolic increased Heart rate increased |
300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Other AEs: Insomnia, Headache... Other AEs: Insomnia (grade 1, 21.9%) Sources: Headache (grade 1, 15.6%) Hypervigilance (grade 1, 9.4%) Decreased appetite (grade 1, 9.4%) Nausea (grade 1, 9.4%) Insomnia (grade 1, 21.9%) Headache (grade 1, 12.5%) Hypervigilance (grade 1, 12.5%) Decreased appetite (grade 1, 9.4%) Nausea (grade 1, 6.3%) |
1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Disc. AE: Blood pressure increased, Nervousness... Other AEs: Hypervigilance, Elevated mood... AEs leading to discontinuation/dose reduction: Blood pressure increased (grade 1, 2.4%) Other AEs:Nervousness (grade 1, 2.4%) Hypervigilance (42.9%) Sources: Elevated mood (23.8%) Dry mouth (21.4%) Nausea (21.4%) Feeling of relaxation (19%) Decreased appetite (19%) Hyperhidrosis (19%) Insomnia (16.7%) Headache (14.3%) Restlessness (14.3%) Palpitations (11.9%) Paresthesia (7.1%) |
150 mg 1 times / day multiple, oral (mean) Studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy n = 417 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Sex: M+F Population Size: 417 Sources: |
Disc. AE: Blood pressure increased, Hypertension... AEs leading to discontinuation/dose reduction: Blood pressure increased (0.48%) Sources: Hypertension (0.24%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Headache | 16% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Palpitations | 2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Constipation | 3% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Dry mouth | 4% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Insomnia | 5% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Anxiety | 6% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Nausea | 7% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Decreased appetite | 9% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Agitation | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Bruxism | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Chest discomfort | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Chest pain | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Cough | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Feeling jittery | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Hyperhidrosis | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Irritability | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Thirst | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Weight decreased | <2% | 112.5 mg 1 times / day steady, oral (mean) Recommended Dose: 112.5 mg, 1 times / day Route: oral Route: steady Dose: 112.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 161 Health Status: unhealthy Condition: narcolepsy Age Group: 18 to 75 years Sex: M+F Population Size: 161 Sources: |
Anxiety | 0.5% Disc. AE |
150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Palpitations | 0.5% Disc. AE |
150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Restlessness | 0.5% Disc. AE |
150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Headache | 13% | 150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Dry mouth | 4% | 150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Diarrhea | 5% | 150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Anxiety | 7% | 150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Decreased appetite | 8% | 150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Nausea | 9% | 150 mg 1 times / day steady, oral (mean) Recommended Dose: 150 mg, 1 times / day Route: oral Route: steady Dose: 150 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 218 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 218 Sources: |
Anxiety | 2% | 37.5 mg 1 times / day steady, oral (mean) Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: steady Dose: 37.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 58 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 58 Sources: |
Decreased appetite | 2% | 37.5 mg 1 times / day steady, oral (mean) Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: steady Dose: 37.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 58 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 58 Sources: |
Diarrhea | 2% | 37.5 mg 1 times / day steady, oral (mean) Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: steady Dose: 37.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 58 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 58 Sources: |
Dry mouth | 2% | 37.5 mg 1 times / day steady, oral (mean) Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: steady Dose: 37.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 58 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 58 Sources: |
Headache | 7% | 37.5 mg 1 times / day steady, oral (mean) Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: steady Dose: 37.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 58 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 58 Sources: |
Nausea | 7% | 37.5 mg 1 times / day steady, oral (mean) Recommended Dose: 37.5 mg, 1 times / day Route: oral Route: steady Dose: 37.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 58 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 58 Sources: |
Anxiety | 3% | 75 mg 1 times / day steady, oral (mean) Recommended Dose: 75 mg, 1 times / day Route: oral Route: steady Dose: 75 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 120 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 120 Sources: |
Dry mouth | 3% | 75 mg 1 times / day steady, oral (mean) Recommended Dose: 75 mg, 1 times / day Route: oral Route: steady Dose: 75 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 120 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 120 Sources: |
Diarrhea | 4% | 75 mg 1 times / day steady, oral (mean) Recommended Dose: 75 mg, 1 times / day Route: oral Route: steady Dose: 75 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 120 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 120 Sources: |
Nausea | 5% | 75 mg 1 times / day steady, oral (mean) Recommended Dose: 75 mg, 1 times / day Route: oral Route: steady Dose: 75 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 120 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 120 Sources: |
Decreased appetite | 7% | 75 mg 1 times / day steady, oral (mean) Recommended Dose: 75 mg, 1 times / day Route: oral Route: steady Dose: 75 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 120 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 120 Sources: |
Headache | 9% | 75 mg 1 times / day steady, oral (mean) Recommended Dose: 75 mg, 1 times / day Route: oral Route: steady Dose: 75 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 120 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 120 Sources: |
Chest discomfort | 2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Dizziness | 2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Hyperhidrosis | 2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Abdominal pain | 3% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Dry mouth | 3% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Feeling jittery | 3% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Irritability | 3% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Palpitations | 3% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Anxiety | 4% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Diarrhea | 4% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Decreased appetite | 6% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Nausea | 8% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Bruxism | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Constipation | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Cough | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Disturbance in attention | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Dyspnea | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Restlessness | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Tremor | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Vomiting | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Weight decreased | <2% | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 235 Health Status: unhealthy Condition: obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 235 Sources: |
Blood pressure diastolic increased | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 396 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 396 Sources: |
|
Blood pressure systolic increased | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 396 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 396 Sources: |
|
Heart rate increased | 87.5 mg 1 times / day steady, oral (mean) Recommended Dose: 87.5 mg, 1 times / day Route: oral Route: steady Dose: 87.5 mg, 1 times / day Sources: |
unhealthy, 18 to 75 years n = 396 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Age Group: 18 to 75 years Sex: M+F Population Size: 396 Sources: |
|
Headache | grade 1, 12.5% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Hypervigilance | grade 1, 12.5% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Headache | grade 1, 15.6% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Insomnia | grade 1, 21.9% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Insomnia | grade 1, 21.9% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Nausea | grade 1, 6.3% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Decreased appetite | grade 1, 9.4% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Decreased appetite | grade 1, 9.4% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Hypervigilance | grade 1, 9.4% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Nausea | grade 1, 9.4% | 300 mg 1 times / day single, oral Studied dose Dose: 300 mg, 1 times / day Route: oral Route: single Dose: 300 mg, 1 times / day Sources: |
healthy, 19 to 54 years n = 32 Health Status: healthy Age Group: 19 to 54 years Sex: M+F Population Size: 32 Sources: |
Palpitations | 11.9% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Headache | 14.3% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Restlessness | 14.3% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Insomnia | 16.7% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Decreased appetite | 19% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Feeling of relaxation | 19% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Hyperhidrosis | 19% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Dry mouth | 21.4% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Nausea | 21.4% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Elevated mood | 23.8% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Hypervigilance | 42.9% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Paresthesia | 7.1% | 1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Blood pressure increased | grade 1, 2.4% Disc. AE |
1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Nervousness | grade 1, 2.4% Disc. AE |
1200 mg 1 times / day single, oral Highest studied dose Dose: 1200 mg, 1 times / day Route: oral Route: single Dose: 1200 mg, 1 times / day Sources: |
healthy, mean age 29.3 years n = 42 Health Status: healthy Age Group: mean age 29.3 years Sex: M Population Size: 42 Sources: |
Hypertension | 0.24% Disc. AE |
150 mg 1 times / day multiple, oral (mean) Studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy n = 417 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Sex: M+F Population Size: 417 Sources: |
Blood pressure increased | 0.48% Disc. AE |
150 mg 1 times / day multiple, oral (mean) Studied dose Dose: 150 mg, 1 times / day Route: oral Route: multiple Dose: 150 mg, 1 times / day Sources: |
unhealthy n = 417 Health Status: unhealthy Condition: narcolepsy | obstructive sleep apnea Sex: M+F Population Size: 417 Sources: |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
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/2019/211230Orig1Orig2s000PharmR.pdf#page=30 Page: 30.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211230Orig1Orig2s000PharmR.pdf#page=30 Page: 30.0 |
no | |||
weak [IC50 146 uM] | ||||
weak [IC50 211 uM] | ||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211230Orig1Orig2s000PharmR.pdf#page=30 Page: 30.0 |
weak [IC50 360 uM] |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
no | ||||
no | ||||
no | ||||
no | ||||
no | ||||
no |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211230Orig1Orig2s000PharmR.pdf#page=20 Page: 20.0 |
PubMed
Title | Date | PubMed |
---|---|---|
Effect of oral JZP-110 (ADX-N05) treatment on wakefulness and sleepiness in adults with narcolepsy. | 2015 Sep |
|
Effect of Oral JZP-110 (ADX-N05) on Wakefulness and Sleepiness in Adults with Narcolepsy: A Phase 2b Study. | 2016 Jul 1 |
|
New developments in the management of narcolepsy. | 2017 |
Sample Use Guides
The dual-acting dopamine and norepinephrine reuptake inhibitor is approved for narcolepsy in once-daily 75 mg and 150 mg doses, and in obstructive sleep apnea in once-daily 37.5 mg, 75 mg, and 150 mg doses.
Route of Administration:
Oral
Solriamfetol binds to the dopamine transporter and norepinephrine transporter with low affinity (Ki=14.2 uM and 3.7 uM, respectively), and inhibits the reuptake of dopamine and norepinephrine with low potency (IC50 =2.9 uM and 4.4 uM, respectively). Solriamfetol has no appreciable binding affinity for the serotonin transporter (Ki=81.5 uM) and does not inhibit serotonin reuptake (IC50 > 100 uM).
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Classification Tree | Code System | Code | ||
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NCI_THESAURUS |
C78272
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C152389
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Solriamfetol
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ACTIVE MOIETY
METABOLITE (PARENT)
METABOLITE (PARENT)
METABOLITE INACTIVE (PARENT)
SALT/SOLVATE (PARENT)