Prescription Referral Form
Efficacy in Pediatric Patients
- WAKIX demonstrated a 5.5-point mean reduction in PDSS total score from baseline versus 2.1 points with placebo1,†
- Mean PDSS total scores at baseline1,‡
- Placebo: 20.0
- WAKIX: 20.2
CI, confidence interval; LS, least squares; PDSS, Pediatric Daytime Sleepiness Scale.
*Placebo-subtracted difference (95% CI: -5.52, -1.31).
†LS mean change in PDSS total score from baseline to mean of the final 2 weeks (Week 7 and Week 8).1
‡Baseline values shown as raw mean values.1
Study 4 design
8-week, multicenter, randomized, double-blind, placebo-controlled study in 110 pediatric patients 6 to 17 years of age with narcolepsy with or without cataplexy (based on ICSD-3 criteria). WAKIX was initiated at 4.45 mg once daily and could be increased at weekly intervals to 17.8 mg (patients weighing <40 kg) or 35.6 mg (patients weighing ≥40 kg) once daily based on clinical response and tolerability. After the 4-week titration period, patients were treated with a stable dosage for an additional 4 weeks. No dosage adjustments were permitted during the stable dose phase.
ICSD-3, International Classification of Sleep Disorders, 3rd edition.
