Sodium oxybate for cataplexy.
OBJECTIVE
To review the pharmacology, pharmacokinetics, clinical efficacy, adverse effects, drug interactions, precautions, dosing recommendations, and patient counseling of sodium oxybate for the treatment of cataplexy in patients with narcolepsy.


METHODS
OVID and PubMed databases were searched (1966-January 2006) using the key words sodium oxybate, gamma-hydroxybutyrate, narcolepsy, and cataplexy. Only English-language articles were selected.


METHODS
All information on sodium oxybate related to narcolepsy and cataplexy was considered. Study selection included human trials evaluating safety and efficacy of sodium oxybate for the treatment of cataplexy.


RESULTS
Sodium oxybate is approved by the Food and Drug Administration for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. In placebo-controlled trials, sodium oxybate demonstrated efficacy in reducing the number of cataplexy attacks. The dosing regimen includes a split dose given at bedtime and 2.5-4 hours later due to its short elimination half-life. The drug is generally well tolerated, with headache, nausea, dizziness, pain, and somnolence being the most common adverse events.


CONCLUSIONS
Sodium oxybate is safe and effective for the treatment of cataplexy. Potential disadvantages include a multiple dosing regimen, abuse potential, cost, and a closed distribution system. Potential advantages demonstrated in clinical trials include significant decreases in the number of weekly cataplexy attacks, improvement in daytime sleepiness, and improvement in the Clinical Global Impression of Change score and nighttime awakenings. Overall, sodium oxybate provides a new option for the treatment of cataplexy.
Lemon
Michael D
MD
College of Pharmacy, South Dakota State University; Veterans Affairs Black Hills Health Care System, Fort Meade, 57741, USA. Michael.lemon@med.va.gov
Strain
Joe D
JD
Farver
Debra K
DK
D002385:Cataplexy / Q000150:complications / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D016208:Databases, Factual; D006801:Humans; D009290:Narcolepsy / Q000150:complications; D012890:Sleep / Q000187:drug effects; D012978:Sodium Oxybate / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*
D012978:Sodium Oxybate