WAKIX Safety and Tolerability Profile in Clinical Studies

  • In the placebo-controlled clinical studies conducted in 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%)
Adverse Reactions That Occurred in ≥5% of WAKIX-Treated Patients 
and More Frequently Than in Placebo-Treated Patients*
Adverse ReactionWAKIX 
(n=152)
Placebo 
(n=114)
Headache18%15%
Insomnia6%2%
Nausea6%3%
Upper respiratory tract infection5%3%
Musculoskeletal pain5%3%
Anxiety5%1%
  • 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
  • No clinically significant changes in mean values for blood pressure were observed in double-blind, placebo-controlled narcolepsy studies1

Patient discontinuations due to an adverse event*

  • 3.9% (n=6/152) with WAKIX
  • 3.5% (n=4/114) with placebo