Pharmacokinetics & Drug Interactions

Pharmacokinetic (PK) and Drug Interaction Information for WAKIX

The PK profile of WAKIX supports once-daily dosing

Median t_1/2 ~20 hours (7.5 to 24.2 hours) after a single 35.6-mg dose
Median T_max 3.5 hours (2 to 5 hours)
No clinically significant PK differences were observed following administration with a high-fat meal

t_1/2, half-life; T_max, time to maximum concentration.

WAKIX had no clinically important PK interactions with modafinil or sodium oxybate

In a clinical PK study to evaluate the concomitant use of WAKIX with modafinil or sodium oxybate, WAKIX had no effect on the PK of modafinil or sodium oxybate, and these agents had no clinically relevant effect on the PK of WAKIX

WAKIX and Modafinil

WAKIX and Sodium Oxybate

Effect of WAKIX on modafinil

WAKIX had no effect on the PK of modafinil

Effect of modafinil on WAKIX

Modafinil had no clinically relevant effect on the PK of WAKIX

*Seventeen healthy male subjects received treatment with a single dose of 35.6 mg WAKIX on Day 1, modafinil 200 mg/day from Day 5 to Day 25, and a single dose of 35.6 mg WAKIX plus 200 mg modafinil on Day 26.¹

Some medications have clinically important drug interactions with WAKIX
Effect of Other Drugs on WAKIX
Strong CYP2D6 Inhibitors	Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold
Strong CYP3A4 Inducers	Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%
Histamine 1 (H₁) Receptor Antagonists	WAKIX increases the levels of histamine in the brain; therefore, H₁ receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX
Drugs Known to Prolong QT Interval	Concomitant use of drugs that prolong the QT interval may add to the QT effects of WAKIX and increase the risk of cardiac arrhythmia
Effect of WAKIX on Other Drugs
Sensitive CYP3A4 Substrates	WAKIX is a borderline/weak inducer of CYP3A4; therefore, reduced effectiveness of sensitive CYP3A4 substrates may occur when used concomitantly with WAKIX The effectiveness of hormonal contraceptives (e.g., ethinyl estradiol) may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy

See Full Prescribing Information for prevention or management of drug interactions.

Dosing WAKIX with other medications
Some medications have clinically important drug interactions with
WAKIX. Identify drug interactions and recommendations for dosing
WAKIX with other medications.

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