Results With WAKIX in the Adult Clinical Trials

WAKIX significantly reduced excessive daytime sleepiness (EDS) compared with placebo

WAKIX was studied for the treatment of EDS in two clinical trials (Trial 1 and Trial 2) in 159 adult patients with narcolepsy. WAKIX was compared with placebo (sugar pill) using the Epworth Sleepiness Scale (ESS)A questionnaire that measures the level of EDS by seeing how likely you are to doze or fall asleep in 8 everyday situations..

At the start of the trials, the majority of patients reported severe EDS

Their ESSEpworth Sleepiness Scale (ESS): A questionnaire that measures the level of EDS by seeing how likely you are to doze or fall asleep in 8 everyday situations. scores were 16 or higher, which means they had a high chance of dozing or falling asleep in everyday situations, such as:

Reading

Watching TV

Sitting and talking

At the end of the trials…

• 

  ESS scores were significantly improved for patients taking WAKIX compared with placebo

  This means patients taking WAKIX reported a significantly lower ESS score, or lower chance of dozing or falling asleep in everyday situations compared with placebo.

• Everyone responds to medication differently. Individual responses varied in the clinical trials.

Significantly fewer cataplexy attacks with WAKIX compared with placebo

WAKIX was studied for the treatment of cataplexy in two clinical trials (Trial 3 and Trial 1) in 154 adult patients with narcolepsy. WAKIX was compared with placebo (sugar pill) by measuring how often patients in the trials experienced cataplexy. One trial measured the number of weekly cataplexy attacks and the other trial measured the number of daily cataplexy attacks.

At the start of the trial measuring weekly cataplexy attacks, on average, patients had about 8 cataplexy attacks per week

Examples of cataplexy include:

Knees buckling

Hand weakness(dropping objects)

Jaw sagging

At the end of this trial…

• 

  Patients taking WAKIX had about half as many cataplexy attacks per week compared with patients taking placebo

Everyone responds to medication differently. Individual responses varied in the clinical trials.

WAKIX side effects in the adult clinical trials

In clinical trials of adult patients with narcolepsy, the most common side effects of WAKIX that were at least twice the rate of placebo (sugar pill) were:

Insomnia

Nausea

Anxiety

n indicates the number of patients who were treated with WAKIX or received placebo.

• 

  Other side effects of WAKIX in the adult clinical trials included 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.