U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C10H14N2O2
Molecular Weight 194.2307
Optical Activity UNSPECIFIED
Defined Stereocenters 1 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of SOLRIAMFETOL

SMILES

c1ccc(cc1)C[C@]([H])(COC(=N)O)N

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

HIDE SMILES / InChI
Molecular Formula C10H14N2O2
Molecular Weight 194.2307
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 1 / 1
E/Z Centers 0
Optical Activity UNSPECIFIED

Description

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

2019
98
Targets

Targets

Primary TargetPharmacologyConditionPotency
Inhibitor
7701
 2.89999999999999991 µM [IC50]
Inhibitor
7701
 4.40000000000000036 µM [IC50]
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
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

AUC

ValueDoseCo-administeredAnalytePopulation
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

T1/2

ValueDoseCo-administeredAnalytePopulation
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

Doses

DosePopulationAdverse events​
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Other AEs: Decreased appetite, Insomnia...
Other AEs:
Decreased appetite (9%)
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%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Disc. AE: Anxiety, Palpitations...
Other AEs: Headache, Nausea...
AEs leading to
discontinuation/dose reduction:
Anxiety (0.5%)
Palpitations (0.5%)
Restlessness (0.5%)
Other AEs:
Headache (13%)
Nausea (9%)
Decreased appetite (8%)
Anxiety (7%)
Dry mouth (4%)
Diarrhea (5%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
37.5 mg 1 times / day steady, oral
Recommended
Dose: 37.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 37.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Other AEs: Headache, Nausea...
Other AEs:
Headache (7%)
Nausea (7%)
Decreased appetite (2%)
Anxiety (2%)
Dry mouth (2%)
Diarrhea (2%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
75 mg 1 times / day steady, oral
Recommended
Dose: 75 mg, 1 times / day
Route: oral
Route: steady
Dose: 75 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Other AEs: Headache, Nausea...
Other AEs:
Headache (9%)
Nausea (5%)
Decreased appetite (7%)
Anxiety (3%)
Dry mouth (3%)
Diarrhea (4%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Other AEs: Decreased appetite, Anxiety...
Other AEs:
Decreased appetite (6%)
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%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Other AEs: Blood pressure systolic increased, Blood pressure diastolic increased...
Other AEs:
Blood pressure systolic increased
Blood pressure diastolic increased
Heart rate increased
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
Other AEs: Insomnia, Headache...
Other AEs:
Insomnia (grade 1, 21.9%)
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%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
Disc. AE: Blood pressure increased, Nervousness...
Other AEs: Hypervigilance, Elevated mood...
AEs leading to
discontinuation/dose reduction:
Blood pressure increased (grade 1, 2.4%)
Nervousness (grade 1, 2.4%)
Other AEs:
Hypervigilance (42.9%)
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%)
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
unhealthy
Health Status: unhealthy
Sex: M+F
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
Disc. AE: Blood pressure increased, Hypertension...
AEs leading to
discontinuation/dose reduction:
Blood pressure increased (0.48%)
Hypertension (0.24%)
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
AEs

AEs

AESignificanceDosePopulation
Headache 16%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Palpitations 2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Constipation 3%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Dry mouth 4%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Insomnia 5%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Anxiety 6%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Nausea 7%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Decreased appetite 9%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Agitation <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Bruxism <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Chest discomfort <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Chest pain <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Cough <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Feeling jittery <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Hyperhidrosis <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Irritability <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Thirst <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Weight decreased <2%
112.5 mg 1 times / day steady, oral
Recommended
Dose: 112.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 112.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Anxiety 0.5%
Disc. AE
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Palpitations 0.5%
Disc. AE
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Restlessness 0.5%
Disc. AE
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Headache 13%
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Dry mouth 4%
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Diarrhea 5%
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Anxiety 7%
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Decreased appetite 8%
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Nausea 9%
150 mg 1 times / day steady, oral
Recommended
Dose: 150 mg, 1 times / day
Route: oral
Route: steady
Dose: 150 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Anxiety 2%
37.5 mg 1 times / day steady, oral
Recommended
Dose: 37.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 37.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Decreased appetite 2%
37.5 mg 1 times / day steady, oral
Recommended
Dose: 37.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 37.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Diarrhea 2%
37.5 mg 1 times / day steady, oral
Recommended
Dose: 37.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 37.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Dry mouth 2%
37.5 mg 1 times / day steady, oral
Recommended
Dose: 37.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 37.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Headache 7%
37.5 mg 1 times / day steady, oral
Recommended
Dose: 37.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 37.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Nausea 7%
37.5 mg 1 times / day steady, oral
Recommended
Dose: 37.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 37.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Anxiety 3%
75 mg 1 times / day steady, oral
Recommended
Dose: 75 mg, 1 times / day
Route: oral
Route: steady
Dose: 75 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Dry mouth 3%
75 mg 1 times / day steady, oral
Recommended
Dose: 75 mg, 1 times / day
Route: oral
Route: steady
Dose: 75 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Diarrhea 4%
75 mg 1 times / day steady, oral
Recommended
Dose: 75 mg, 1 times / day
Route: oral
Route: steady
Dose: 75 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Nausea 5%
75 mg 1 times / day steady, oral
Recommended
Dose: 75 mg, 1 times / day
Route: oral
Route: steady
Dose: 75 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Decreased appetite 7%
75 mg 1 times / day steady, oral
Recommended
Dose: 75 mg, 1 times / day
Route: oral
Route: steady
Dose: 75 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Headache 9%
75 mg 1 times / day steady, oral
Recommended
Dose: 75 mg, 1 times / day
Route: oral
Route: steady
Dose: 75 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Chest discomfort 2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Dizziness 2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Hyperhidrosis 2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Abdominal pain 3%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Dry mouth 3%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Feeling jittery 3%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Irritability 3%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Palpitations 3%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Anxiety 4%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Diarrhea 4%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Decreased appetite 6%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Nausea 8%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Bruxism <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Constipation <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Cough <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Disturbance in attention <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Dyspnea <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Restlessness <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Tremor <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Vomiting <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Weight decreased <2%
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Blood pressure diastolic increased
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Blood pressure systolic increased
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
Heart rate increased
87.5 mg 1 times / day steady, oral
Recommended
Dose: 87.5 mg, 1 times / day
Route: oral
Route: steady
Dose: 87.5 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
unhealthy, 18 to 75 years
Health Status: unhealthy
Age Group: 18 to 75 years
Sex: M+F
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211230s000lbl.pdf
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://pubmed.ncbi.nlm.nih.gov/30598342/
healthy, 19 to 54 years
Health Status: healthy
Age Group: 19 to 54 years
Sex: M+F
Sources:
https://pubmed.ncbi.nlm.nih.gov/30598342/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
healthy, mean age 29.3 years
Health Status: healthy
Age Group: mean age 29.3 years
Sex: M
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
https://pubmed.ncbi.nlm.nih.gov/30269642/
Hypertension 0.24%
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
unhealthy
Health Status: unhealthy
Sex: M+F
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
Blood pressure increased 0.48%
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:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
unhealthy
Health Status: unhealthy
Sex: M+F
Sources:
https://www.ema.europa.eu/en/documents/assessment-report/sunosi-epar-public-assessment-report_en.pdf
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
1318
inhibitor
1421
inhibitor
1360

OverviewOther

Other InhibitorOther SubstrateOther Inducer
CYP1A2
1268

CYP2A6
594

CYP2B6
679

CYP2C8
761

CYP2C19
1215

CYP2E1
761

CYP3A4/5
225

UGT
29

P-gp
1089

BCRP
574

OATP1B1
698

OATP1B3
613

OAT1
547

OAT3
570

OCT1
473

MATE2
258

OCTN1
28

OCTN2
66

OCT2
582

MATE1
290

UGT1A
3

UGT2B7
130
P-gp
1223

BCRP
461

OATP1B1
353

OATP1B3
303

OAT1
290

OAT3
299
CYP1A2
618

CYP2B6
486

CYP3A4/5
107

UGT
24
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BCRP
639
 no
CYP1A2
1406
 no
CYP1A2
1406
 no
CYP2A6
625
 no
CYP2B6
845
 no
CYP2B6
845
 no
CYP2C19
1277
 no
CYP2C8
810
 no
CYP2C9
1362
 no
CYP2E1
841
 no
CYP3A4/5
277
 no
CYP3A4/5
277
 no
MATE2
258
 no
OAT1
551
 no
OAT3
572
 no
OATP1B1
713
 no
OATP1B3
622
 no
OCT1
488
 no
OCTN1
28
 no
OCTN2
71
 no
P-gp
1255
 no
UGT
49
 no
UGT
49
 no
UGT1A
5
 no
UGT2B7
138
 no
OCT2
583
 weak [IC50 146 uM]
MATE1
291
 weak [IC50 211 uM]
CYP2D6
1455
 weak [IC50 360 uM]
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
BCRP
461
 no
OAT1
290
 no
OAT3
299
 no
OATP1B1
353
 no
OATP1B3
303
 no
P-gp
1223
 no
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
1392
Sourcing

Sourcing

Vendor/AggregatorIDURL
1PlusChem LLC
1P01C3BA
A2B Chem
AW42982
AA Blocks
AA01C2RU
AChemBlock
Q69522
Chem Scene
CS-0031486
Chem Scene
CS-0112102
ChemShuttle
139041
Chemspace
CSC041015464
Enamine
BBV-44122269
Enamine
BBV-77772338
Enamine
EN300-253107
Hairui
R2CQ017
MedChem Express
HY-109043
MedChem Express
HY-109043A
MolPort
MolPort-039-241-646
MolPort
MolPort-046-793-373
MolPort
MolPort-047-156-022
Molnova
M12688
MuseChem
I009552
Toronto Research Chemicals
S676775
ZINC
ZINC000034278783
http://zinc15.docking.org/substances/ZINC000034278783
eMolecules
222563444
eMolecules
303230315
eMolecules
67911099
mcule
MCULE-3233675360
PubMed

PubMed

TitleDatePubMed
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

In Vivo Use Guide
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
In Vitro Use Guide
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).
Substance Class Chemical
Created
by admin
on Sat Jun 26 02:36:59 UTC 2021
Edited
by admin
on Sat Jun 26 02:36:59 UTC 2021
Record UNII
939U7C91AI
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
SOLRIAMFETOL
USAN   INN  
Official Name English
(2R)-2-AMINO-3-PHENYLPROPYL CARBAMATE
Systematic Name English
SOLRIAMFETOL [ORANGE BOOK]
Common Name English
YKP-10A
Code English
R-228060
Code English
SOLRIAMFETOL [WHO-DD]
Common Name English
SUNOSI
Brand Name English
BENZENEPROPANOL, .BETA.-AMINO-, CARBAMATE (ESTER), (R)-
Systematic Name English
BENZENEPROPANOL, .BETA.-AMINO-, 1-CARBAMATE, (.BETA.R)-
Systematic Name English
JZP-110
Code English
SOLRIAMFETOL [INN]
Common Name English
ADX-N-05
Code English
SKL-N-05
Code English
SOLRIAMFETOL [USAN]
Common Name English
SOLRIAMFETOL [MI]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C78272
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
Code System Code Type Description
INN
10117
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
DRUG CENTRAL
5325
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
RXCUI
2121751
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
MERCK INDEX
M12132
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
FDA UNII
939U7C91AI
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
CAS
178429-62-4
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
PUBCHEM
10130337
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
DRUG BANK
DB14754
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
NCI_THESAURUS
C152389
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
LACTMED
Solriamfetol
Created by admin on Sat Jun 26 02:36:59 UTC 2021 , Edited by admin on Sat Jun 26 02:36:59 UTC 2021
PRIMARY
Related Record Type Details
Structure of SOLRIAMFETOL HYDROCHLORIDE
SALT/SOLVATE -> PARENT
OCT-2
TRANSPORTER -> INHIBITOR
WEAK
IC50
MULTIDRUG AND TOXIN EXTRUSION PROTEIN 1
TRANSPORTER -> INHIBITOR
WEAK
IC50
PLASMA PROTEIN FRACTION (HUMAN)
BINDER->LIGAND
BINDING
Structure of SOLRIAMFETOL
EXCRETED UNCHANGED
Approximately 95% of the dose was recovered in urine as unchanged solriamfetol, 1% or less of the administered dose was recovered in urine as the minor inactive metabolite N-acetyl solriamfetol.
URINE
SODIUM-DEPENDENT DOPAMINE TRANSPORTER
TARGET -> INHIBITOR
Ki
SODIUM-DEPENDENT NORADRENALINE TRANSPORTER
TARGET -> INHIBITOR
Ki
Related Record Type Details
Structure of N-ACETYL SOLRIAMFETOL
METABOLITE INACTIVE -> PARENT
Structure of PHENYLALANINOL, D-
METABOLITE -> PARENT
Related Record Type Details
Structure of SOLRIAMFETOL
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
Volume of Distribution PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC
ORAL BIOAVAILABILITY PHARMACOKINETIC
Tmax PHARMACOKINETIC
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
DISCLAIMER
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National Center for Advancing Translational Sciences (NCATS),
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