Excessive Daytime Sleepiness (EDS)

Daytime sleepiness significantly decreased, as assessed by the Epworth Sleepiness Scale (ESS)[1][2]

Trial 3: From an 8-week, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial of narcolepsy patients (N=228) with moderate to severe EDS and cataplexy symptoms. Antidepressants were withdrawn prior to randomization, and stimulants were continued throughout the study at stable doses.

  • A 37% reduction in ESS score seen with 9 g/night
    • Patients taking XYREM® had scores closer to the normal range at end point
    • Improvements in ESS scores demonstrated in a dose-dependent manner
    • 78% of patients were being treated with CNS stimulants
      • 41% of patients in the study were maintained on modafinil

The ESS is a subjective patient questionnaire that evaluates the extent of daytime sleepiness in everyday situations.
Scale: 0-8 normal, 9-12 mild, 13-16 moderate, ≥17 severe

Source: [1][2]

Daytime wakefulness significantly increased, as assessed by the Maintenance of Wakefulness Test (MWT)[1][2]

Trial 4: From an 8-week, double-dummy trial that assessed 222 narcolepsy patients with moderate to severe symptoms. The patients enrolled in the study were randomized to 1 of 4 treatment groups: placebo, XYREM, modafinil, and XYREM plus modafinil. Patients were randomized to receive XYREM 6 g/night for 4 weeks and then 9 g/night for 4 weeks or placebo. The primary efficacy measure was objective change in EDS, as measured by MWT.

  • The MWT is an objective measurement of latency to sleep onset (in minutes) following nocturnal polysomnography
    • Higher scores indicate greater wakefulness
  • XYREM and XYREM plus modafinil both provided significant improvements beyond baseline modafinil treatment when compared to placebo
  • In this trial, patients had to be taking modafinil for 1 month and at stable doses of 200, 400, or 600 mg daily prior to randomization
  • This trial was not designed to compare the effects of XYREM to modafinil, because patients receiving modafinil were not titrated to a maximally effective dose

The effective dose range of XYREM is 6 to 9 g/night

References:

  1. ^ The XYREM® International Study Group. A double-blind, placebo-controlled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J Clin Sleep Med. 2005;1:391–397.
  2. ^ XYREM® (sodium oxybate) [prescribing information]. Palo Alto, Calif: Jazz Pharmaceuticals; 2005.

Important Safety Information

1. XYREM® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence. XYREM is a Schedule III drug — which means that it has a moderate dependence liability. If you sell, distribute, or give your XYREM to anyone else or use it for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines.

2. It is very important to keep XYREM out of reach of children and pets.

3. XYREM can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression and loss of consciousness. Tell your doctor if you have any of these problems while taking XYREM.

BOXED WARNING:

!Warning

Central Nervous System Depressant with Abuse Potential. Should not be used with alcohol or other CNS depressants. Sodium oxybate is a form of GHB, a known drug of abuse. Abuse has been associated with some important central nervous system (CNS) adverse events (including death). Even at recommended doses, use has been associated with confusion, depression, and other neuropsychiatric events. Reports of respiratory depression occurred in clinical trials. Almost all of the patients who received sodium oxybate during clinical trials were receiving CNS stimulants.

Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases in level of consciousness, with instances of coma and death. For events that occurred outside of clinical trials, in people taking GHB for recreational purposes, the circumstances surrounding the events are often unclear (e.g., dose of GHB taken, the nature and amount of alcohol or any concomitant drugs).

XYREM is available through the XYREM Success Program®, using a centralized pharmacy 1-866-XYREM88® (1-866-997-3688). The Success Program provides educational materials to the prescriber and the patient explaining the risks and proper use of sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the materials, the drug will be shipped to the patient. The XYREM Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.

The product information provided in this site is intended for residents of the United States only.

© 2008 Jazz Pharmaceuticals, Inc.