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) or severe (eGFR of 15 to 29 mL/minute/1.73 m2) renal impairment, initiate WAKIX at 8.9 mg once daily and increase after 7 days to a maximum dosage of 17.8 mg once daily [see Warnings and Precautions (5.1), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

WAKIX is not recommended in patients with end-stage renal disease (ESRD) (eGFR of <15 mL/minute/1.73 m2)[see Warnings and Precautions (5.1), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

Dosage Recommendations for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers

Coadministration with Strong CYP2D6 Inhibitors

For patients receiving strong CYP2D6 inhibitors, initiate WAKIX at 8.9 mg once daily and increase after 7 days to a maximum dosage of 17.8 mg once daily.

For patients on a stable dose of WAKIX, reduce the WAKIX dose by half upon initiating strong CYP2D6 inhibitors [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Coadministration with Strong CYP3A4 Inducers

Concomitant use of WAKIX with strong CYP3A4 inducers decreases pitolisant exposure by 50%. Assess for loss of efficacy after initiation of a strong CYP3A4 inducer.

For patients stable on WAKIX 8.9 mg or 17.8 mg once daily, increase the dose of WAKIX to double the original daily dose (i.e., 17.8 mg or 35.6 mg, respectively) over 7 days.

If concomitant dosing of a strong CYP3A4 inducer is discontinued, decrease WAKIX dosage by half [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Use in Patients Who Are Known CYP2D6 Poor Metabolizers (PMs)

In patients known to be poor CYP2D6 metabolizers, initiate WAKIX at 8.9 mg once daily and titrate to a maximum dose of 17.8 mg once daily after 7 days [see Use in Specific Populations (8.8), Clinical Pharmacology (12.5)].