Comparing three doses of oral sodium oxybate to placebo for treating narcolepsy in a controlled trial
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Abstract
Weekly cataplexy attacks were significantly reduced by sodium oxybate at the 9 g dose (p=0.0008).
- A decrease in weekly cataplexy attacks was observed at the 6 g dose (p=0.0529), but it was significant only at the 9 g dose.
- Daytime sleepiness, measured by the Epworth Sleepiness Scale, showed a significant reduction at the 9 g dose (p=0.0001).
- Improvements in overall disease severity were noted, with significant changes at the 9 g dose (p=0.0002).
- The frequency of inadvertent naps and nighttime awakenings exhibited similar dose-response trends, becoming significant at the 9 g dose (p=0.0122 and p=0.0035, respectively).
- Sodium oxybate was generally well tolerated, with nausea, headache, dizziness, and enuresis being the most commonly reported adverse events.
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