Full Prescribing Information Important Safety Information Medication Guide

What is Xyrem?

Cataplexy in Narcolepsy: Xyrem (sodium oxybate) oral solution is indicated for the treatment of cataplexy in narcolepsy.

Excessive Daytime Sleepiness in Narcolepsy: Xyrem (sodium oxybate) oral solution is indicated for the treatment of excessive daytime sleepiness (EDS) in narcolepsy.

  • In three controlled clinical trials, the most common adverse reactions (incidence ≥5% and twice the rate seen with placebo) in Xyrem-treated patients were nausea, dizziness, vomiting, somnolence, enuresis, and tremor. Additional adverse reactions occurring in ≥ 2% of Xyrem-treated patients and more frequently than placebo were diarrhea, upper abdominal pain, dry mouth, pain, feeling drunk, peripheral edema, extremity pain, cataplexy, muscle spasms, paresthesia, attention disturbance, sleep paralysis, disorientation, anxiety, irritability, sleep walking, and hyperhidrosis.
  • The most common adverse reaction leading to discontinuation was nausea (2.8%). The majority of adverse reactions leading to discontinuation began during the first few weeks of treatment.

To report an adverse event please call: 1-800-520-5568

 

 

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