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The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy.
Sleep Med. 2009 Sep; 10(8):829-35.SM

Abstract

BACKGROUND

Previous studies indicate that nightly sodium oxybate administration reduces nocturnal sleep disruption in narcolepsy. The present study provided an opportunity to further characterize these sleep-related effects in patients with narcolepsy during treatment with sodium oxybate as monotherapy or in combination with modafinil.

METHODS

This double-blind, placebo-controlled study enrolled 278 patients with narcolepsy taking modafinil 200-600 mg daily for the treatment of excessive daytime sleepiness (EDS). Following a baseline polysomnogram (PSG) and Maintenance of Wakefulness Test (MWT), patients were randomized to receive treatment with: (1) placebo, (2) sodium oxybate, (3) modafinil, or (4) sodium oxybate+modafinil. PSGs and MWTs were repeated after 4 and 8 weeks. Other efficacy measures included Epworth Sleepiness Scale scores and daily diary recordings.

RESULTS

After 8 weeks, significant changes in sleep architecture among patients receiving sodium oxybate and sodium oxybate/modafinil included a median increase in Stage 3 and 4 sleep (43.5 and 24.25 min, respectively) and delta power and a median decrease in nocturnal awakenings (6.0 and 9.5, respectively). No significant changes in PSG parameters were noted in patients treated with placebo or modafinil alone.

CONCLUSIONS

In addition to its established efficacy for the treatment of cataplexy and EDS, nightly sodium oxybate administration significantly reduces measures of sleep disruption and significantly increases slow-wave sleep in patients with narcolepsy.

Authors+Show Affiliations

Stanford Sleep Disorders Clinic, 401 Quary Road, Stanford, CA 94305, USA. jedblack@stanford.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19616998

Citation

Black, Jed, et al. "The Nightly Administration of Sodium Oxybate Results in Significant Reduction in the Nocturnal Sleep Disruption of Patients With Narcolepsy." Sleep Medicine, vol. 10, no. 8, 2009, pp. 829-35.
Black J, Pardi D, Hornfeldt CS, et al. The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy. Sleep Med. 2009;10(8):829-35.
Black, J., Pardi, D., Hornfeldt, C. S., & Inhaber, N. (2009). The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy. Sleep Medicine, 10(8), 829-35. https://doi.org/10.1016/j.sleep.2009.05.004
Black J, et al. The Nightly Administration of Sodium Oxybate Results in Significant Reduction in the Nocturnal Sleep Disruption of Patients With Narcolepsy. Sleep Med. 2009;10(8):829-35. PubMed PMID: 19616998.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy. AU - Black,Jed, AU - Pardi,Daniel, AU - Hornfeldt,Carl S, AU - Inhaber,Neil, Y1 - 2009/07/18/ PY - 2009/01/21/received PY - 2009/04/27/revised PY - 2009/05/01/accepted PY - 2009/7/21/entrez PY - 2009/7/21/pubmed PY - 2009/12/18/medline SP - 829 EP - 35 JF - Sleep medicine JO - Sleep Med VL - 10 IS - 8 N2 - BACKGROUND: Previous studies indicate that nightly sodium oxybate administration reduces nocturnal sleep disruption in narcolepsy. The present study provided an opportunity to further characterize these sleep-related effects in patients with narcolepsy during treatment with sodium oxybate as monotherapy or in combination with modafinil. METHODS: This double-blind, placebo-controlled study enrolled 278 patients with narcolepsy taking modafinil 200-600 mg daily for the treatment of excessive daytime sleepiness (EDS). Following a baseline polysomnogram (PSG) and Maintenance of Wakefulness Test (MWT), patients were randomized to receive treatment with: (1) placebo, (2) sodium oxybate, (3) modafinil, or (4) sodium oxybate+modafinil. PSGs and MWTs were repeated after 4 and 8 weeks. Other efficacy measures included Epworth Sleepiness Scale scores and daily diary recordings. RESULTS: After 8 weeks, significant changes in sleep architecture among patients receiving sodium oxybate and sodium oxybate/modafinil included a median increase in Stage 3 and 4 sleep (43.5 and 24.25 min, respectively) and delta power and a median decrease in nocturnal awakenings (6.0 and 9.5, respectively). No significant changes in PSG parameters were noted in patients treated with placebo or modafinil alone. CONCLUSIONS: In addition to its established efficacy for the treatment of cataplexy and EDS, nightly sodium oxybate administration significantly reduces measures of sleep disruption and significantly increases slow-wave sleep in patients with narcolepsy. SN - 1878-5506 UR - https://www.unboundmedicine.com/medline/citation/19616998/The_nightly_administration_of_sodium_oxybate_results_in_significant_reduction_in_the_nocturnal_sleep_disruption_of_patients_with_narcolepsy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(09)00223-8 DB - PRIME DP - Unbound Medicine ER -