woman narcolepsy 2

“What clinical effects were seen for excessive daytime sleepiness (EDS) in narcolepsy in adults?”

XYREM significantly improved the ability to sustain wakefulness.1,2

The results of the XYREM Trial N4 showed...

  • XYREM, with or without modafinil, and at a dosage of 9 g per night, significantly reduced EDS as measured by improvements in Maintenance of Wakefulness Test (MWT) scores at week 8.1,2
STUDY RESULTS
Change in Wakefulness on MWT at Week 81,2*
Xyrem trial n4 change in wakefulness on MWT graph

*This trial was not designed to compare the effects of XYREM with modafinil because patients receiving modafinil were not titrated to a maximally effective dose.1

Trial N4 Study Description

Study Design1,2

  • Randomized, double-blind, placebo-controlled, parallel-group, multicenter trial
  • Compared effects of orally administered XYREM, modafinil, and the combination of the 2 with placebo for the treatment of EDS in narcolepsy

Patients Studied1,2

  • 222 adult patients with narcolepsy with inclusion criteria featuring:
    • The use of a stimulant medication for EDS for at least 3 months, and stable dosages of 200 mg to 600 mg of modafinil daily, for at least 1 month prior to the trial, or stable doses of modafinil for at least 6 weeks prior to the trial
  • Patients were permitted to remain on antidepressant medications at unchanged dosages throughout the trial
  • Patients were not allowed to have used XYREM or any investigational therapy within the 30-day period prior to the trial

Baseline Characteristics1,2

  • Mean age: 38.6 years
  • Moderate to severe symptoms at study entry:
    • Median Epworth Sleepiness Scale (ESS) score of 15
    • Mean Maintenance of Wakefulness Test (MWT) score of 10.3 minutes

Objective1,2

  • Evaluate the efficacy of XYREM as monotherapy and in combination with modafinil compared with placebo in the treatment of EDS in narcolepsy*

Primary Efficacy Measure1,2

  • EDS as measured by the 20-minute MWT

*This trial was not designed to compare the effects of XYREM with modafinil because patients receiving modafinil were not titrated to a maximally effective dose.

Trial N4 Study Design1,2,4

Xyrem efficacy in excessive daytime sleepiness n4 study design flowchart

*Weeks 1–4 = XYREM 6 g per night; weeks 5–8 = XYREM 9 g per night.

†Weeks 1–4 = XYREM 6 g per night + modafinil; weeks 5–8 = XYREM 9 g per night + modafinil.

Modafinil was continued at patients’ prior dose in the modafinil alone and XYREM + modafinil treatment groups.

It is recommended that XYREM be titrated at weekly intervals, by adding 1.5 g per night, from 4.5 g to the effective dosage range of 6 g to 9 g per night.1
The American Academy of Sleep Medicine (AASM) recommends sodium oxybate as a standard of care for the treatment of EDS in narcolepsy.3