The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy.

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: Jed Black, Daniel Pardi, Carl S Hornfeldt, Neil Inhaber
• Journal: Sleep medicine (Sleep Med) Vol. 10 Issue 8 Pg. 829-35 (Sep 2009) ISSN: 1878-5506 [Electronic] Netherlands
• PMID: 19616998 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adjuvants, Anesthesia
• Benzhydryl Compounds
• Central Nervous System Stimulants
• Placebos
• Sodium Oxybate
• Modafinil

Topics

• Adjuvants, Anesthesia (administration & dosage, adverse effects)
• Adult
• Benzhydryl Compounds (administration & dosage, adverse effects)
• Central Nervous System Stimulants (administration & dosage, adverse effects)
• Drug Therapy, Combination
• Female
• Humans
• Male
• Middle Aged
• Modafinil
• Narcolepsy (complications, drug therapy)
• Placebos
• Polysomnography
• Sleep (drug effects)
• Sleep Wake Disorders (drug therapy, etiology)
• Sodium Oxybate (administration & dosage, adverse effects)
• Wakefulness (drug effects)