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 excessive daytime sleepiness (EDS) in children 6 years of age and older with narcolepsy.
EDS in Children 6-17 Years Old
Results With WAKIX in the Clinical Trial of Children 6-17 Years Old
Significantly reduced excessive daytime sleepiness (EDS) 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 of 110 patients (aged 6-17 years) with narcolepsy.
WAKIX was compared with placebo (sugar pill) using the Pediatric Daytime Sleepiness Scale (PDSS) questionnaire.
This questionnaire 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:
- 72 patients were treated with WAKIX, and 38 patients received placebo.
- 90 of the patients in the trial had narcolepsy with cataplexy, and 20 patients had narcolepsy without cataplexy.
At the end of the trial…
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 8-week clinical trial of 110 patients (aged 6-17 years) with narcolepsy, the most common side effects of WAKIX were headache and 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. Tell your healthcare provider about any side effect that is bothersome or that does not go away.
