Side Effects
- The most commonly reported adverse events (≥5%) in placebo-controlled trials (n=655) associated with the use of sodium oxybate and occurring more frequently than seen in placebo-treated patients
- In all clinical trials (n=717), 10% of patients discontinued because of adverse events. The most frequent reasons for discontinuation (>1%) were: nausea (2%), dizziness (2%), and vomiting (1%)
- 40 patients with narcolepsy and mild to severe sleep disordered breathing were included in 2 trials
- None had clinically significant worsening of respiratory function as measured by apnea/hypopnea index and pulse oximetry (4.5–9 g/night).
- Caution should be observed if XYREM® is prescribed to patients with compromised respiratory function.[1]
To report an adverse event please call: 1-800-520-5568
References:
- ^ XYREM® (sodium oxybate) [prescribing information]. Palo Alto, Calif: Jazz Pharmaceuticals, Inc.
