child narcolepsy 3

“What kind of side effects can my child experience with XYREM?”

XYREM demonstrated a similar safety profile in children and adolescents as previously observed in adults.1

In a placebo-controlled, randomized-withdrawal XYREM clinical study of patients aged 7 to 17 years with narcolepsy...

  • The most common adverse reactions (≥5%) were1:
    • Enuresis (18.3%)
    • Nausea (17.3%)
    • Headache (16.3%)
    • Vomiting (16.3%)
    • Weight decreased (11.5%)
    • Decreased appetite (7.7%)
    • Nasopharyngitis (7.7%)
    • Dizziness (5.8%)
  • The majority of events were mild or moderate in severity.1
  • The incidence of adverse reactions was higher in pediatric patients who were XYREM-naïve at study entry compared with patients who were receiving XYREM prior to study entry.2,3
  • Five of 104 patients (4.8%) discontinued because of adverse events, which included1:
    • Tactile hallucination
    • Suicidal ideation
    • Weight decreased
    • Sleep apnea syndrome
    • Affect lability

The safety and effectiveness of XYREM in pediatric patients less than 7 years old have not been established in clinical trials.1