Abstract：
BACKGROUND AND PURPOSE:This study was conducted to demonstrate the long-term efficacy of sodium oxybate for the long-term treatment of cataplexy in patients with narcolepsy. PATIENTS AND METHODS:Fifty-five (55) narcoleptic patients with cataplexy who had received continuous treatment with sodium oxybate for 7-44 months (mean 21 months) were enrolled in a double-blind treatment withdrawal paradigm. A 2-week single-blind sodium oxybate treatment phase established a baseline for the weekly occurrence of cataplexy. This was followed by a 2-week double-blind phase in which patients were randomized to receive unchanged drug therapy or placebo. Patients recorded the incidence of cataplexy attacks and adverse events in daily diaries. RESULTS:During the 2-week double-blind phase, the abrupt cessation of sodium oxybate therapy in the placebo patients resulted in a significant increase in the number of cataplexy attacks (median=21; P<0.001 ) compared to patients who remained on sodium oxybate (median=0). Cataplexy attacks returned gradually with placebo patients reporting a median of 4.2 and 11.7 cataplexy attacks during the first and second weeks, respectively. There were no symptoms of frank withdrawal. CONCLUSIONS:This controlled trial provides evidence supporting the long-term efficacy of sodium oxybate for the treatment of cataplexy. In contrast with antidepressant drug therapy, there is no evidence of rebound cataplexy upon abrupt discontinuation of treatment.
journal_name
Sleep Medjournal_title
Sleep medicineauthors
U.S. Xyrem Multicenter Study Group.doi
10.1016/j.sleep.2003.11.002keywords:
subject
Has Abstractpub_date
2004-03-01 00:00:00pages
119-23issue
2eissn
1389-9457issn
1878-5506pii
S1389945703002491journal_volume
5pub_type
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