Scores on the PDSS were significantly improved for patients taking WAKIX compared with placebo
This means patients taking WAKIX reported falling asleep or getting drowsy less often during the day compared with patients who took placebo.
Now FDA approved to treat
cataplexy in children 6 years of age and older with narcolepsy.
Children 6-17 Years Old With Narcolepsy
Results With WAKIX in the Clinical Trial of Children 6-17 Years Old
Significantly reduced excessive daytime sleepiness (EDS) and significantly fewer cataplexy attacks in patients 6-17 years old with narcolepsy compared with placebo
EDS Results
WAKIX significantly reduced excessive daytime sleepiness (EDS) compared with placebo
WAKIX was studied for the treatment of EDS in a clinical trial in 110 patients (aged 6-17 years) with narcolepsy.
WAKIX was compared with placebo (sugar pill) using the Pediatric Daytime Sleepiness Scale (PDSS).
The PDSS uses an overall score to measure excessive daytime sleepiness by asking 8 questions about how often one falls asleep or gets drowsy during the day in situations such as:
Homework
Classroom
In this 8-week clinical trial:
- 95 of the patients in the trial had narcolepsy with cataplexy, and 15 patients had narcolepsy without cataplexy.
- PDSS scores were evaluated for 72 patients treated with WAKIX, and 38 patients receiving placebo.
At the end of the trial…
Everyone responds to medication differently. Individual responses varied in the clinical trial.
Cataplexy Results
Significantly fewer cataplexy attacks with WAKIX compared with placebo
In the same trial, WAKIX was studied for the treatment of cataplexy in patients (aged 6-17 years) who had narcolepsy with cataplexy
- WAKIX was compared with placebo (sugar pill) by measuring how many times in a week patients in the trial experienced cataplexy.
- Cataplexy was defined as sudden muscle weakness often triggered by emotions. Examples of cataplexy include:
In this 8-week clinical trial:
- The number of cataplexy attacks per week was evaluated in 65 patients treated with WAKIX, and 30 patients receiving placebo.
At the end of the trial…
Patients taking WAKIX had fewer cataplexy attacks per week compared with patients taking placebo
Everyone responds to medication differently. Individual responses varied in the clinical trial.
Side Effects
WAKIX side effects in the clinical trial of children 6-17 years old
In the clinical trial of patients aged 6-17 years with narcolepsy, the most common side effects of WAKIX (≥5% and greater than the rate of placebo) were:
Headache
Insomnia
Side effects that occurred in at least 5% of patients treated with WAKIX and more frequently than placebo
n indicates the number of patients who were treated with WAKIX.
Overall, the side effects seen in the clinical trial of patients aged 6-17 years with narcolepsy were similar to those seen in adult clinical trials.
In the clinical trials of adults with narcolepsy:
- The most common side effects of WAKIX were insomnia, nausea, and anxiety.
- Other side effects of WAKIX included headache, upper respiratory tract infection, musculoskeletal pain, increased heart rate, hallucinations, irritability, abdominal pain, sleep disturbance, and decreased appetite.
These are not all the possible side effects of WAKIX. Call your healthcare provider for medical advice about side effects.
