48789
document
The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption : a double-blind , placebo-controlled study in patients with narcolepsy . OBJECTIVE To further explore the effects of sodium oxybate ( SXB ) administration on nocturnal sleep in narcolepsy patients during a double-blind , placebo-controlled , parallel group study conducted with 228 adult patients with narcolepsy/cataplexy in the United States , Canada , and Europe . METHOD Patients were withdrawn from antidepressants and sedative/hypnotics , and then randomized to receive 4.5 , 6 , or 9 g SXB or placebo nightly for 8 weeks . Patients receiving 6 and 9 g/night doses were titrated to their final dose in weekly 1.5 g increments , while patients receiving placebo were randomized to undergo a similar mock dose titration . The use of stimulant therapy continued unchanged . Changes in sleep architecture were measured using centrally scored nocturnal polysomnograms . Daily diaries were used to record changes in narcolepsy symptoms and adverse events . RESULTS Following 8 weeks of SXB treatment , study patients demonstrated significant dose-related increases in the duration of stage 3 and 4 sleep , reaching a median increase of 52.5 minutes in patients receiving 9 g nightly . Compared to placebo-treated patients , delta power was significantly increased in all dose groups . Stage 1 sleep and the frequency of nocturnal awakenings were each significantly decreased at the 6 and 9 g/night doses . The changes in nocturnal sleep coincided with significant decreases in the severity and frequency of narcolepsy symptoms . CONCLUSIONS The nightly administration of SXB to narcolepsy patients significantly impacts measures of slow wave sleep , wake after sleep onset , awakenings , total sleep time , and stage 1 sleep in a dose-related manner . The frequency and severity of narcolepsy symptoms decreased with treatment .
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Intervention_Pharmacological
sodium oxybate
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
sodium oxybate ( SXB )
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Intervention_Pharmacological
withdrawn from antidepressants and sedative/hypnotics
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Intervention_Control
placebo
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Intervention_Control
placebo
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Outcome_Physical
nocturnal sleep disruption
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Outcome_Physical
nocturnal sleep
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Outcome_Other
Changes in sleep architecture
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Outcome_Other
centrally scored nocturnal polysomnograms
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Outcome_Adverse-effects
changes in narcolepsy symptoms and adverse events .
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Outcome_Other
duration of stage 3 and 4 sleep
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Outcome_Other
delta power
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Outcome_Other
Stage 1 sleep and the frequency of nocturnal awakenings
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Outcome_Physical
changes in nocturnal sleep
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Outcome_Physical
severity and frequency of narcolepsy symptoms
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Outcome_Physical
slow wave sleep
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Outcome_Physical
wake after sleep onset
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Outcome_Physical
awakenings
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Outcome_Other
total sleep time
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Outcome_Physical
stage 1 sleep
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Outcome_Other
frequency and severity of narcolepsy symptoms
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Participant_Condition
nocturnal sleep disruption :
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Participant_Condition
patients with narcolepsy .
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Participant_Age
narcolepsy patients
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Participant_Age
228 adult patients with narcolepsy/cataplexy in the United States , Canada , and Europe .