Details
Stereochemistry | ACHIRAL |
Molecular Formula | C17H26ClNO |
Molecular Weight | 295.847 |
Optical Activity | NONE |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
ClC1=CC=C(CCCOCCCN2CCCCC2)C=C1
InChI
InChIKey=NNACHAUCXXVJSP-UHFFFAOYSA-N
InChI=1S/C17H26ClNO/c18-17-9-7-16(8-10-17)6-4-14-20-15-5-13-19-11-2-1-3-12-19/h7-10H,1-6,11-15H2
Molecular Formula | C17H26ClNO |
Molecular Weight | 295.847 |
Charge | 0 |
Count |
|
Stereochemistry | ACHIRAL |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Optical Activity | NONE |
DescriptionSources: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002616/WC500204746.pdfCurator's Comment: description was created based on several sources, including
https://www.google.com/patents/WO2000006254A2 | https://www.drugs.com/uk/wakix.html | https://www.ncbi.nlm.nih.gov/pubmed/28087755 | https://www.ncbi.nlm.nih.gov/pubmed/27568835 | https://www.ncbi.nlm.nih.gov/pubmed/27223666
Sources: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002616/WC500204746.pdf
Curator's Comment: description was created based on several sources, including
https://www.google.com/patents/WO2000006254A2 | https://www.drugs.com/uk/wakix.html | https://www.ncbi.nlm.nih.gov/pubmed/28087755 | https://www.ncbi.nlm.nih.gov/pubmed/27568835 | https://www.ncbi.nlm.nih.gov/pubmed/27223666
Pitolisant (INN) or tiprolisant (USAN) is a histamine receptor inverse agonist/antagonist selective for the H3 subtype. It has stimulant and nootropic effects in animal studies and may have several medical applications, having been researched for the treatment of narcolepsy, for which it has been granted orphan drug status in the EU and US. It is currently in clinical trials for schizophrenia and Parkinson’s disease. Pitolisant hydrochloride was approved by European Medicine Agency (EMA) on Mar 31, 2016. It was developed and marketed as Wakix® by Bioprojet in EU. Wakix® is available as the tablet for oral use, containing 4.5 mg and 18 mg of Pitolisant hydrochloride. The initial dose of 9 mg (two 4.5 mg, tablets) per day, and it should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day. Pitolisant was the first clinically used H3 receptor inverse agonist.
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL264 Sources: https://www.ncbi.nlm.nih.gov/pubmed/18841880 |
12.0 nM [IC50] | ||
Target ID: CHEMBL231 Sources: https://www.ncbi.nlm.nih.gov/pubmed/24650714 |
1148.15 nM [Ki] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | Wakix Approved UseTherapeutic indications. Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy |
|||
Primary | Wakix Approved UseTherapeutic indications. Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy |
|||
Primary | Wakix Approved UseTherapeutic indications. Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
73 ng/mL |
35.6 mg 1 times / day steady-state, oral dose: 35.6 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
PITOLISANT unknown | Homo sapiens population: UNKNOWN age: ADULT sex: UNKNOWN food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
812 ng × h/mL |
35.6 mg 1 times / day steady-state, oral dose: 35.6 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
PITOLISANT unknown | Homo sapiens population: UNKNOWN age: ADULT sex: UNKNOWN food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
20 h |
35.6 mg 1 times / day steady-state, oral dose: 35.6 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
PITOLISANT unknown | Homo sapiens population: UNKNOWN age: ADULT sex: UNKNOWN food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
6.5% |
35.6 mg 1 times / day steady-state, oral dose: 35.6 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
PITOLISANT unknown | Homo sapiens population: UNKNOWN age: ADULT sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
240 mg single, oral Highest studied dose Dose: 240 mg Route: oral Route: single Dose: 240 mg Sources: |
healthy, adults Health Status: healthy Age Group: adults Sex: unknown Sources: |
|
50 mg 1 times / day multiple, oral Highest studied dose Dose: 50 mg, 1 times / day Route: oral Route: multiple Dose: 50 mg, 1 times / day Sources: |
healthy, adults Health Status: healthy Age Group: adults Sex: unknown Sources: |
|
53.4 mg 1 times / day steady, oral (max) Highest studied dose Dose: 53.4 mg, 1 times / day Route: oral Route: steady Dose: 53.4 mg, 1 times / day Sources: |
unhealthy, adults n = 6 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 6 Sources: |
|
17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Disc. AE: Anxiety, Depression... Other AEs: Anxiety, Depression... AEs leading to discontinuation/dose reduction: Anxiety Other AEs:Depression Insomnia Hypnagogic hallucination Cataplexy Myalgia Somnolence Abdominal pain Headache Anxiety Sources: Page: P09-15Depression Insomnia Hypnagogic hallucination Cataplexy Myalgia Somnolence Abdominal pain Headache |
35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Other AEs: Cluster headache, Headache... Other AEs: Cluster headache (18%) Sources: Headache (18%) Migraine (18%) Premenstrual headache (18%) Tension headache (18%) Initial insomnia (6%) Insomnia (6%) Middle insomnia (6%) Poor quality sleep (6%) Nausea (6%) Pharyngitis (5%) Rhinitis (5%) Sinusitis (5%) Upper respiratory tract infection (5%) Upper respiratory tract inflammation (5%) Viral upper respiratory tract infection (5%) Arthralgia (5%) Back pain (5%) Carpal tunnel syndrome (5%) Limb discomfort (5%) Musculoskeletal pain (5%) Myalgia (5%) Neck pain (5%) Osteoarthritis (5%) Pain in extremity (5%) Sciatica (5%) Nervousness (5%) Stress (5%) Stress at work (5%) Heart rate increased (3%) Sinus tachycardia (3%) Tachycardia (3%) Hallucination visual (3%) Hypnagogic hallucination (3%) Irritability (3%) Abdominal discomfort (3%) Abdominal pain (3%) Abdominal pain upper (3%) Dyssomnia (3%) Sleep disorder (3%) Sleep paralysis (3%) Sleep talking (3%) Decreased appetite (3%) Cataplexy (2%) Dry mouth (2%) Eczema (2%) Erythema migrans (2%) Rash (2%) Urticaria (2%) Cluster headache (18%) Headache (18%) Migraine (18%) Premenstrual headache (18%) Tension headache (18%) Initial insomnia (6%) Insomnia (6%) Middle insomnia (6%) Poor quality sleep (6%) Nausea (6%) Pharyngitis (5%) Rhinitis (5%) Sinusitis (5%) Upper respiratory tract infection (5%) Upper respiratory tract inflammation (5%) Viral upper respiratory tract infection (5%) Arthralgia (5%) Back pain (5%) Carpal tunnel syndrome (5%) Limb discomfort (5%) Musculoskeletal pain (5%) Myalgia (5%) Neck pain (5%) Osteoarthritis (5%) Pain in extremity (5%) Sciatica (5%) Nervousness (5%) Stress (5%) Stress at work (5%) Heart rate increased (3%) Sinus tachycardia (3%) Tachycardia (3%) Hallucination visual (3%) Hypnagogic hallucination (3%) Irritability (3%) Abdominal discomfort (3%) Abdominal pain (3%) Abdominal pain upper (3%) Dyssomnia (3%) Sleep disorder (3%) Sleep paralysis (3%) Sleep talking (3%) Decreased appetite (3%) Cataplexy (2%) Dry mouth (2%) Eczema (2%) Erythema migrans (2%) Rash (2%) Urticaria (2%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Abdominal pain | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Anxiety | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Cataplexy | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Depression | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Headache | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Hypnagogic hallucination | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Insomnia | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Myalgia | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Somnolence | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
|
Abdominal pain | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Anxiety | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Cataplexy | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Depression | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Headache | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Hypnagogic hallucination | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Insomnia | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Myalgia | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Somnolence | Disc. AE | 17.8 mg 1 times / day multiple, oral (max) Recommended Dose: 17.8 mg, 1 times / day Route: oral Route: multiple Dose: 17.8 mg, 1 times / day Sources: Page: P09-15 |
unhealthy, adults n = 166 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 166 Sources: Page: P09-15 |
Cluster headache | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Cluster headache | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Headache | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Headache | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Migraine | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Migraine | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Premenstrual headache | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Premenstrual headache | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Tension headache | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Tension headache | 18% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Cataplexy | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Cataplexy | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Dry mouth | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Dry mouth | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Eczema | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Eczema | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Erythema migrans | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Erythema migrans | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Rash | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Rash | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Urticaria | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Urticaria | 2% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Abdominal discomfort | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Abdominal discomfort | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Abdominal pain upper | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Abdominal pain upper | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Abdominal pain | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Abdominal pain | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Decreased appetite | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Decreased appetite | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Dyssomnia | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Dyssomnia | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Hallucination visual | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Hallucination visual | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Heart rate increased | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Heart rate increased | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Hypnagogic hallucination | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Hypnagogic hallucination | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Irritability | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Irritability | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sinus tachycardia | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sinus tachycardia | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sleep disorder | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sleep disorder | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sleep paralysis | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sleep paralysis | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sleep talking | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sleep talking | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Tachycardia | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Tachycardia | 3% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Arthralgia | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Arthralgia | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Back pain | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Back pain | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Carpal tunnel syndrome | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Carpal tunnel syndrome | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Limb discomfort | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Limb discomfort | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Musculoskeletal pain | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Musculoskeletal pain | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Myalgia | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Myalgia | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Neck pain | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Neck pain | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Nervousness | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Nervousness | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Osteoarthritis | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Osteoarthritis | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Pain in extremity | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Pain in extremity | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Pharyngitis | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Pharyngitis | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Rhinitis | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Rhinitis | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sciatica | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sciatica | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sinusitis | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Sinusitis | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Stress at work | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Stress at work | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Stress | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Stress | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Upper respiratory tract infection | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Upper respiratory tract infection | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Upper respiratory tract inflammation | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Upper respiratory tract inflammation | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Viral upper respiratory tract infection | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Viral upper respiratory tract infection | 5% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Initial insomnia | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Initial insomnia | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Insomnia | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Insomnia | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Middle insomnia | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Middle insomnia | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Nausea | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Nausea | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Poor quality sleep | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Poor quality sleep | 6% | 35.6 mg 1 times / day multiple, oral (typical) Recommended Dose: 35.6 mg, 1 times / day Route: oral Route: multiple Dose: 35.6 mg, 1 times / day Sources: |
unhealthy, adults n = 152 Health Status: unhealthy Condition: excessive daytime sleepiness (EDS) Age Group: adults Sex: unknown Population Size: 152 Sources: |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Drug as perpetrator
Drug as victim
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211150Orig1s000ClinPharmR.pdf#page=23 Page: 23.0 |
PubMed
Title | Date | PubMed |
---|---|---|
Keynote review: histamine H3 receptor antagonists reach out for the clinic. | 2005 Dec |
|
Brain histamine and schizophrenia: potential therapeutic applications of H3-receptor inverse agonists studied with BF2.649. | 2007 Apr 15 |
|
BF2.649 [1-{3-[3-(4-Chlorophenyl)propoxy]propyl}piperidine, hydrochloride], a nonimidazole inverse agonist/antagonist at the human histamine H3 receptor: Preclinical pharmacology. | 2007 Jan |
|
Histamine H3 antagonists as wake-promoting and pro-cognitive agents. | 2008 |
|
An inverse agonist of the histamine H(3) receptor improves wakefulness in narcolepsy: studies in orexin-/- mice and patients. | 2008 Apr |
|
Diether derivatives of homo- or substituted piperidines as non-imidazole histamine H3 receptor ligands. | 2009 Apr 15 |
|
5-hydroxyindole-2-carboxylic acid amides: novel histamine-3 receptor inverse agonists for the treatment of obesity. | 2009 Jul 9 |
|
Recent advances in histamine H3 receptor antagonists/inverse agonists. | 2010 Sep |
|
Discovery and characterization of 6-{4-[3-(R)-2-methylpyrrolidin-1-yl)propoxy]phenyl}-2H-pyridazin-3-one (CEP-26401, irdabisant): a potent, selective histamine H3 receptor inverse agonist. | 2011 Jul 14 |
|
The histamine H3 receptor: from discovery to clinical trials with pitolisant. | 2011 Jun |
|
International Union of Basic and Clinical Pharmacology. XCVIII. Histamine Receptors. | 2015 Jul |
Sample Use Guides
Wakix (Pitolisant) should be used at the lowest effective dose, depending on individual patient response and tolerance, according to an up-titration scheme, without exceeding the dose of 36 mg/day:
- Week 1: initial dose of 9 mg (two 4.5 mg tablets) per day.
- Week 2: the dose may be increased to 18 mg (one 18 mg tablet) per day or decreased to 4.5 mg (one 4.5 mg tablet) per day.
- Week 3: the dose may be increased to 36 mg (two 18 mg tablets) per day.
At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to the physician assessment and the patient’s response.
Route of Administration:
Oral
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/17005916
Longitudinal muscle strips from small intestine from guinea pig were dissected out and incubated in a gassed O2/CO2 (95%/5%) modified Krebs-Ringer bicarbonate medium at 37°C in presence of 1 mkM mepyramine to block H1 receptors. After equilibration, contractile activity under stimulation (rectangular pulses of 15 V, 0.5 ms, and 0.1 Hz) was recorded. Concentration-response curves of the effect of (R)-alpha-MeHA alone or together with BF2.649 (Pitolisant) were performed.
Substance Class |
Chemical
Created
by
admin
on
Edited
Sat Dec 16 01:35:11 GMT 2023
by
admin
on
Sat Dec 16 01:35:11 GMT 2023
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Record UNII |
4BC83L4PIY
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Record Status |
Validated (UNII)
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Record Version |
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-
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Classification Tree | Code System | Code | ||
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FDA ORPHAN DRUG |
307210
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admin on Sat Dec 16 01:35:11 GMT 2023 , Edited by admin on Sat Dec 16 01:35:11 GMT 2023
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WHO-ATC |
N07XX11
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admin on Sat Dec 16 01:35:11 GMT 2023 , Edited by admin on Sat Dec 16 01:35:11 GMT 2023
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100000161112
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CHEMBL462605
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m11944
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SUB174467
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4BC83L4PIY
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2197878
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C166747
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SUB166257
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DB11642
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PITOLISANT
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FG-186
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C516975
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5048
Created by
admin on Sat Dec 16 01:35:11 GMT 2023 , Edited by admin on Sat Dec 16 01:35:11 GMT 2023
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362665-56-3
Created by
admin on Sat Dec 16 01:35:11 GMT 2023 , Edited by admin on Sat Dec 16 01:35:11 GMT 2023
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Related Record | Type | Details | ||
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BINDER->LIGAND |
BINDING
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TARGET->INVERSE AGONIST | |||
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METABOLIC ENZYME -> SUBSTRATE | |||
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EXCRETED UNCHANGED |
After a single oral radiolabeled pitolisant 17.8 mg dose, approximately 90% of the dose was excreted in urine (< 2% as unchanged parent) and 2.3% in feces.
AMOUNT EXCRETED
URINE
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SALT/SOLVATE -> PARENT | |||
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METABOLIC ENZYME -> SUBSTRATE |
MAJOR
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Related Record | Type | Details | ||
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METABOLITE INACTIVE -> PARENT |
MAJOR
PLASMA
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METABOLITE -> PARENT | |||
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METABOLITE -> PARENT | |||
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METABOLITE -> PARENT | |||
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METABOLITE INACTIVE -> PARENT |
MAJOR
PLASMA
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METABOLITE INACTIVE -> PARENT |
MAJOR
PLASMA
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METABOLITE -> PARENT | |||
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METABOLITE -> PARENT | |||
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METABOLITE INACTIVE -> PARENT |
MAJOR
PLASMA
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METABOLITE INACTIVE -> PARENT |
MAJOR
PLASMA
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METABOLITE -> PARENT | |||
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METABOLITE -> PARENT |
Related Record | Type | Details | ||
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ACTIVE MOIETY |
Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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blood to plasma ratio | PHARMACOKINETIC |
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Biological Half-life | PHARMACOKINETIC |
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SINGLE DOSE ADMINISTRATION |
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Volume of Distribution | PHARMACOKINETIC |
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Tmax | PHARMACOKINETIC |
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DOSE |
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