Active Ingredient: Pitolisant
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:
For:
Regimen A: Oral, 4.5 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 9 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 18 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, between 4.5 milligrams pitolisant and 18 milligrams pitolisant, once daily to breakfast.
Regimen B: Oral, 4.5 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 9 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, 4.5 milligrams pitolisant, once daily to breakfast, over the duration of 1 week. Afterwards, oral, between 4.5 milligrams pitolisant and 18 milligrams pitolisant, once daily to breakfast.
Treatment should be initiated by a healthcare professional experienced in the treatment of OSA and cardiovascular risk. OSA disease should be annually reassessed.
Pitolisant is not a therapy for the underlying airway obstruction in patients with OSA. Primary OSA therapy should be maintained or periodically rechallenged in patients not tolerating primary OSA therapy.
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 18 mg/day:
Week 1: initial dose of 4.5 mg (one 4.5 mg tablet) per day.
Week 2: the dose may be increased to 9 mg (two 4.5 mg tablets) per day.
Week 3: 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.
At any time the dose can be decreased (down to 4.5 mg per day) or increased (up to 18 mg per day) according to the physician assessment and the patient’s response.
The total daily dose should be administered as a single dose in the morning during breakfast.
As long-term efficacy data are limited, the continued efficacy of treatment should be regularly evaluated by the physician.
Limited data are available in elderly. Therefore, dosing should be adjusted according to their individual response and tolerance. Insomnia has been reported in higher rate in the elderly and dosing should be adjusted accordingly.
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