Wakix Tablets

Generic name:pitolisant hydrochloride
Dosage form: tablet, film coated
Drug class:CNS stimulants

Medically reviewed by Drugs.com. Last updated on Mar 1, 2021.

Indications and Usage for Wakix Tablets

WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.

Wakix Tablets Dosage and Administration

Recommended Dosage

The recommended dosage range for WAKIX is 17.8 mg to 35.6 mg administered orally once daily in the morning upon wakening. Titrate dosage as follows:

Week 1: Initiate with a dosage of 8.9 mg (two 4.45 mg tablets) once daily

Week 2: Increase dosage to 17.8 mg (one 17.8 mg tablet) once daily

Week 3: May increase to the maximum recommended dosage of 35.6 mg (two 17.8 mg tablets) once daily

Dose may be adjusted based on tolerability.

If a dose is missed, patients should take the next dose the following day in the morning upon wakening.

It may take up to 8 weeks for some patients to achieve a clinical response.

Dosage Modification and Recommendations in Patients with Hepatic Impairment

In patients with moderate hepatic impairment, initiate WAKIX at 8.9 mg once daily and increase after 14 days to a maximum dosage of 17.8 mg once daily [see Warnings and Precautions (5.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

WAKIX is contraindicated in patients with severe hepatic impairment. WAKIX has not been studied in patients with severe hepatic impairment [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Dosage Modification and Recommendations in Patients with Renal Impairment and End-Stage Renal Disease

In patients with moderate (eGFR of 30 to 59 mL/minute/1.73 m2) and severe renal impairment (...