XYREM® is FDA approved for excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy
In XYREM clinical trials, approximately 80% of patients maintained concomitant stimulant use
- Daytime sleepiness significantly decreased, as assessed by the Epworth Sleepiness Scale (ESS)[1][2]
- XYREM significantly reduces cataplexy attacks in narcolepsy[2][3]
- The most commonly reported adverse events (≥5%) in placebo-controlled trials (n=655) associated with the use of XYREM and occurring more frequently than seen in placebo–treated patients were: nausea (19%), dizziness (18%), headache (18%), vomiting (8%), somnolence (6%), urinary incontinence (6%), and nasopharyngitis (6%).
- In clinical trials in narcolepsy (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%).
Prescribing XYREM
View our Quick Start Guide for the procedure for writing and dispensing XYREM prescriptions.
- Prescribing Requirements
- Central Pharmacy’s Role and Services
- Physician Registration Form
- Prescription Form
- Titration Form
- Important Safety Information
To report an adverse event please call: 1-800-520-5568
References:
- ^ The XYREM® International Study Group. A double-blind, placebo-controlled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J Clin Sleep Med. 2005;1:391–397.
- ^ XYREM® (sodium oxybate) [prescribing information]. Palo Alto, Calif: Jazz Pharmaceuticals, Inc.
- ^ The US XYREM® Multicenter Study Group. A randomized, double blind, placebo-controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002;25:42–49.
