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Details

Stereochemistry ACHIRAL
Molecular Formula C17H26ClNO
Molecular Weight 295.848
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of PITOLISANT

SMILES

C1CCN(CC1)CCCOCCCc2ccc(cc2)Cl

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

HIDE SMILES / InChI

Molecular Formula C17H26ClNO
Molecular Weight 295.848
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
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.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
12.0 nM [IC50]
1148.15 nM [Ki]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Wakix

Approved Use

Therapeutic indications. Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy
Primary
Wakix

Approved Use

Therapeutic indications. Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy
Primary
Wakix

Approved Use

Therapeutic indications. Wakix is indicated in adults for the treatment of narcolepsy with or without cataplexy
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
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

AUC

ValueDoseCo-administeredAnalytePopulation
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

T1/2

ValueDoseCo-administeredAnalytePopulation
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

Funbound

ValueDoseCo-administeredAnalytePopulation
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

Doses

DosePopulationAdverse 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
Depression
Insomnia
Hypnagogic hallucination
Cataplexy
Myalgia
Somnolence
Abdominal pain
Headache
Other AEs:
Anxiety
Depression
Insomnia
Hypnagogic hallucination
Cataplexy
Myalgia
Somnolence
Abdominal pain
Headache
Sources: Page: P09-15
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%)
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%)
Sources:
AEs

AEs

AESignificanceDosePopulation
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:
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
devoid
devoid
devoid
devoid
devoid
devoid
devoid
devoid
devoid
devoid
no
no
no
no
no
no
no
no
no
not significant
not significant
not significant
not significant
not significant
not significant
weak
no (co-administration study)
Comment: pitolisant does not affect the PK of bupropion (150 mg single dose) and, therefore, does not induce CYP2B6 metabolism.
Page: 29,79
weak
weak (co-administration study)
Comment: using mRNA analysis; weak induction by pitolisant and BP2.951 at 50-fold Cmax at MRHD; pitolisant reduces exposures of midazolam (2.5 mg single dose) about 20%.
Page: 38.0
yes [IC50 0.795 uM]
yes [IC50 2.6 uM]
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
no
no
no
no
no
yes
yes (co-administration study)
Comment: paroxetine (as inhibitor) increased the Cmax and AUC of pitolisant by 1.5-fold and 2.2-fold, respectively
Page: 61.0
yes
yes (co-administration study)
Comment: rifampicin (as inducer) decreased pitolisant Cmax and AUC and by 39% and 48%, respectively; pitosilant with itraconazole had negligible effect on the PK of pitolisant
Page: 70.0
Tox targets

Tox targets

Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
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
Patents

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
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 Sat Jun 26 07:17:17 UTC 2021
Edited
by admin
on Sat Jun 26 07:17:17 UTC 2021
Record UNII
4BC83L4PIY
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
PITOLISANT
WHO-DD  
INN   USAN  
Official Name English
BF2.649
Code English
HBS-101
Code English
PITOLISANT [USAN]
Common Name English
PITOLISANT [MI]
Common Name English
PITOLISANT [WHO-DD]
Common Name English
3-(4-CHLOROPHENYL)PROPYL 3-PIPERIDINOPROPYL ETHER
Systematic Name English
1-(3-(3-(4-CHLOROPHENYL)PROPOXY)PROPYL)PIPERIDINE
Systematic Name English
PITOLISANT [INN]
Common Name English
BF-2.649
Code English
PIPERIDINE, 1-(3-(3-(4-CHLOROPHENYL)PROPOXY)PROPYL)-
Systematic Name English
BF-2649
Code English
Classification Tree Code System Code
WHO-ATC N07XX11
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
FDA ORPHAN DRUG 307210
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
Code System Code Type Description
ChEMBL
CHEMBL462605
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
MERCK INDEX
M11944
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
EVMPD
SUB174467
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
INN
8952
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
FDA UNII
4BC83L4PIY
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
RXCUI
2197878
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
NCI_THESAURUS
C166747
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
EVMPD
SUB166257
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
PUBCHEM
9948102
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
DRUG BANK
DB11642
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
WIKIPEDIA
PITOLISANT
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
MESH
C516975
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
DRUG CENTRAL
5048
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
CAS
362665-56-3
Created by admin on Sat Jun 26 07:17:18 UTC 2021 , Edited by admin on Sat Jun 26 07:17:18 UTC 2021
PRIMARY
Related Record Type Details
BINDER->LIGAND
BINDING
TARGET->INVERSE AGONIST
METABOLIC ENZYME -> SUBSTRATE
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
SALT/SOLVATE -> PARENT
METABOLIC ENZYME -> SUBSTRATE
MAJOR
Related Record Type Details
METABOLITE INACTIVE -> PARENT
MAJOR
PLASMA
METABOLITE -> PARENT
METABOLITE -> PARENT
METABOLITE INACTIVE -> PARENT
MAJOR
PLASMA
METABOLITE -> PARENT
METABOLITE INACTIVE -> PARENT
MAJOR
PLASMA
METABOLITE -> PARENT
METABOLITE -> PARENT
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
blood to plasma ratio PHARMACOKINETIC
Biological Half-life PHARMACOKINETIC SINGLE DOSE ADMINISTRATION

Volume of Distribution PHARMACOKINETIC
Tmax PHARMACOKINETIC DOSE

ORAL ADMINISTRATION

ONCE DAILY