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Impact of sodium oxybate, modafinil, and combination treatment on excessive daytime sleepiness in patients who have narcolepsy with or without cataplexy
Effects of sodium oxybate, modafinil, and their combination on daytime sleepiness in narcolepsy patients with and without muscle weakness episodes
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Abstract
Sodium oxybate (SXB) alone and in combination with modafinil improved subjective sleepiness ratings and objective wakefulness measures in patients with narcolepsy with cataplexy (NC) and without cataplexy (NWOC).
- Both NC and NWOC patients showed significant improvement in the Epworth Sleepiness Scale (ESS) when treated with SXB and SXB + modafinil compared to placebo.
- In NC patients, the mean sleep latency on the Maintenance of Wakefulness Test (MWT) significantly increased with SXB + modafinil versus placebo.
- NWOC patients demonstrated significant increases in mean MWT sleep latency across all treatment groups compared to placebo.
- A higher percentage of patients in the SXB and SXB + modafinil groups reported being 'very much improved' or 'much improved' on the Clinical Global Impression of Change (CGI-C) compared to placebo, although not statistically significant in NWOC populations.
- Nausea was more frequently reported in the SXB and SXB + modafinil groups, while dizziness and tremor were more common in the SXB + modafinil group.
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