WAKIX PrescriptionSafety & Tolerability
Clinical studies in adult patients with narcolepsy
- In the placebo-controlled clinical studies conducted in adult patients with narcolepsy with or without cataplexy, the most common adverse reactions (occurring in ≥5% of patients and at least twice the rate of placebo) with the use of WAKIX were insomnia (6%), nausea (6%), and anxiety (5%)
- Additional adverse reactions* occurring in ≥2% of WAKIX-treated patients and more frequently than in placebo-treated patients were heart rate increased,† hallucinations,† irritability, abdominal pain,† sleep disturbance,† decreased appetite, cataplexy, dry mouth, and rash†
- In narcolepsy clinical studies in which WAKIX was directly compared with placebo, the incidence of patients who discontinued because of an adverse reaction was similar between the WAKIX and placebo groups (3.9% [n=6/152] vs 3.5% [n=4/114], respectively)
*In three placebo-controlled clinical studies conducted in patients with narcolepsy with or without cataplexy.
†Denotes adverse reactions for which similar terms were combined.
Clinical study in pediatric patients (6 years and older) with narcolepsy
- In the placebo-controlled phase of the study, the most common adverse reactions (occurring in ≥5% of patients and greater than the rate of placebo) with the use of WAKIX were headache (19%) and insomnia (7%)
- The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the adult clinical trial program
‡In the placebo-controlled phase of the clinical trial conducted in patients 6 to 17 years of age with narcolepsy with or without cataplexy.
No electrocardiogram baseline tests or labs are required in the Prescribing Information prior to starting WAKIX
- No clinically significant changes in mean values for blood pressure were observed in double-blind, placebo-controlled narcolepsy studies in adults1
- WAKIX prolongs the QT interval. Avoid use of WAKIX with drugs that also increase QT and in patients with risk factors for prolonged QT interval. Monitor patients with hepatic or renal impairment for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD)