Efficacy in Pediatric Patients

WAKIX Significantly Reduced Excessive Daytime Sleepiness Versus Placebo in Pediatric Patients

Significant improvement in LS mean change from baseline to end of treatment in the final PDSS total score with WAKIX versus placebo: -3.41 points (P=0.002)^1,*

WAKIX demonstrated a 5.5-point mean reduction in PDSS total score from baseline versus 2.1 points with placebo^1,†
Mean PDSS total scores at baseline^1,‡
- 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.

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WAKIX Significantly Reduced Excessive Daytime Sleepiness Versus Placebo in Pediatric Patients

Significant improvement in LS mean change from baseline to end of treatment in the final PDSS total score with WAKIX versus placebo: -3.41 points (P=0.002)1,*

Significant improvement in LS mean change from baseline to end of treatment in the final PDSS total score with WAKIX versus placebo: -3.41 points (P=0.002)^1,*