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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.
J Clin Sleep Med. 2010 Dec 15; 6(6):596-602.JC

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Patients were withdrawn from antidepressants and sedative/hypnotics, and then randomized to receive 4.5, 6, or 9 g SXB or placebo nightly for 8 weeks.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

Stanford Sleep Medicine Center, 450 Broadway Street, Pavilion B, 2nd Floor, Redwood City, CA 94063-5730, USA. jedblack@stanford.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21206549

Citation

Black, Jed, et al. "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." Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine, vol. 6, no. 6, 2010, pp. 596-602.
Black J, Pardi D, Hornfeldt CS, et al. 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. J Clin Sleep Med. 2010;6(6):596-602.
Black, J., Pardi, D., Hornfeldt, C. S., & Inhaber, N. (2010). 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. Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine, 6(6), 596-602.
Black J, et al. 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. J Clin Sleep Med. 2010 Dec 15;6(6):596-602. PubMed PMID: 21206549.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Black,Jed, AU - Pardi,Daniel, AU - Hornfeldt,Carl S, AU - Inhaber,Neil, PY - 2011/1/6/entrez PY - 2011/1/6/pubmed PY - 2011/5/26/medline KW - Narcolepsy KW - delta power KW - polysomnography KW - sleep architecture KW - sodium oxybate SP - 596 EP - 602 JF - Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine JO - J Clin Sleep Med VL - 6 IS - 6 N2 - 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. SN - 1550-9397 UR - https://www.unboundmedicine.com/medline/citation/21206549/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_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21206549/ DB - PRIME DP - Unbound Medicine ER -