Pitolisant

Chemical formula: C₁₇H₂₆ClNO Molecular mass: 295.85 g/mol

Therapeutic indications

Pitolisant is indicated for:

Improvement of wakefulness and reduction of excessive daytime sleepiness in obstructive sleep apnoea

Population group: only adults (18 years old or older)

Pitolisant is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

4.5 mg daily at Week 1, 9 mg daily at Week 2, 4.5 mg or 18 mg daily at Week 3 and thereafter 4.5-18 mg daily

Contraindications

Pitolisant is contraindicated in the following cases:

Lactation

Severe hepatic impairment (Child-Pugh C)

Hepatic failure stage IV

Tricyclic antidepressants, tetracyclic antidepressants

at least one of

Tetracyclic antidepressants

Anti-histamines

Antihistamines for systemic use

Substrates of CYP3A4 having a narrow therapeutic margin

CYP3A4 substrates and additionally Narrow Therapeutic Index Drugs (NTI)

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