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.

Abstract

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Patients were withdrawn from antidepressants and sedative/hypnotics, and then randomized to receive 4.5, 6, or 9 g SXB or placebo nightly for 8 weeks.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.

• Authors: Jed Black, Daniel Pardi, Carl S Hornfeldt, Neil Inhaber
• Journal: Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine (J Clin Sleep Med) Vol. 6 Issue 6 Pg. 596-602 (Dec 15 2010) ISSN: 1550-9397 [Electronic] United States
• PMID: 21206549 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adjuvants, Anesthesia
• Sodium Oxybate

Topics

• Adjuvants, Anesthesia (administration & dosage, adverse effects)
• Administration, Oral
• Adolescent
• Adult
• Aged
• Analysis of Variance
• Cataplexy (diagnosis, drug therapy)
• Circadian Rhythm
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Narcolepsy (diagnosis, drug therapy)
• Polysomnography (methods)
• Reference Values
• Severity of Illness Index
• Sodium Oxybate (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome
• Young Adult