Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026
Sodium oxybate for excessive daytime sleepiness in narcolepsy: a systematic review and meta-analysis of randomized placebo-controlled trials.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод пока не подготовлен
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Kanawjia Preeti, Kanaujia Surendra Kumar, Kumari Renu
Аннотация
BACKGROUND & OBJECTIVES: Excessive daytime sleepiness (EDS) is a debilitating symptom in narcolepsy. Sodium oxybate (SO) is approved for narcolepsy and has shown consistent efficacy across multiple formulations. This systematic review and meta-analysis aimed to evaluate the efficacy and safety of SO compared to placebo in reducing EDS in patients with narcolepsy.
METHODS: A systematic search was conducted in PubMed, Cochrane Library, and ClinicalTrials.gov from inception to March 2024. Randomized, double-blind, placebo-controlled trials of SO in narcolepsy reporting Epworth Sleepiness Scale (ESS) scores were included. Primary outcome was change in ESS from baseline. Mean difference (MD) with 95% confidence intervals (CI) was pooled using a random-effects model. Heterogeneity was assessed using I² statistic. Subgroup analyses were performed by formulation and dose. Risk of bias was assessed using Cochrane RoB 2.0 tool. The review followed PRISMA guidelines and was registered with PROSPERO (CRD42024604014).
RESULTS: Five randomized controlled trials (n = 1,066 patients) met inclusion criteria. SO significantly reduced ESS scores compared to placebo (pooled MD: -4.8 points; 95% CI: -5.8 to -3.8; P < 0.001; I²=44%). Subgroup analysis showed comparable effects across formulations: once-nightly extended-release FT218 (MD: -4.9; 95% CI: -6.2 to -3.6), low-sodium oxybate JZP-258 (MD: -4.7; 95% CI: -5.8 to -3.6), and standard twice-nightly (MD: -4.7; 95% CI: -5.7 to -3.7). Objective sleep latency improved by 3.5 min. Cataplexy frequency reduced by 3.3 attacks/week (P < 0.001). Safety outcomes included mild-to-moderate adverse events (nausea 9-18%, dizziness 8-11%, headache 7-11%), with discontinuation rates of 3-11%.
INTERPRETATION & CONCLUSIONS: Sodium oxybate significantly reduces EDS in narcolepsy with consistent effects across formulations. Once-nightly and low-sodium formulations offer additional benefits in terms of dosing convenience and reduced sodium burden. Safety profiles were acceptable, with mild-to-moderate adverse events being most common. Larger trials with longer durations are warranted for validation.
REGISTRATION: PROSPERO (CRD42024604014).
METHODS: A systematic search was conducted in PubMed, Cochrane Library, and ClinicalTrials.gov from inception to March 2024. Randomized, double-blind, placebo-controlled trials of SO in narcolepsy reporting Epworth Sleepiness Scale (ESS) scores were included. Primary outcome was change in ESS from baseline. Mean difference (MD) with 95% confidence intervals (CI) was pooled using a random-effects model. Heterogeneity was assessed using I² statistic. Subgroup analyses were performed by formulation and dose. Risk of bias was assessed using Cochrane RoB 2.0 tool. The review followed PRISMA guidelines and was registered with PROSPERO (CRD42024604014).
RESULTS: Five randomized controlled trials (n = 1,066 patients) met inclusion criteria. SO significantly reduced ESS scores compared to placebo (pooled MD: -4.8 points; 95% CI: -5.8 to -3.8; P < 0.001; I²=44%). Subgroup analysis showed comparable effects across formulations: once-nightly extended-release FT218 (MD: -4.9; 95% CI: -6.2 to -3.6), low-sodium oxybate JZP-258 (MD: -4.7; 95% CI: -5.8 to -3.6), and standard twice-nightly (MD: -4.7; 95% CI: -5.7 to -3.7). Objective sleep latency improved by 3.5 min. Cataplexy frequency reduced by 3.3 attacks/week (P < 0.001). Safety outcomes included mild-to-moderate adverse events (nausea 9-18%, dizziness 8-11%, headache 7-11%), with discontinuation rates of 3-11%.
INTERPRETATION & CONCLUSIONS: Sodium oxybate significantly reduces EDS in narcolepsy with consistent effects across formulations. Once-nightly and low-sodium formulations offer additional benefits in terms of dosing convenience and reduced sodium burden. Safety profiles were acceptable, with mild-to-moderate adverse events being most common. Larger trials with longer durations are warranted for validation.
REGISTRATION: PROSPERO (CRD42024604014).