Dosing and Administration[1]

Recommended Starting Dose

Recommended starting dose is 4.5 g per night

Informing Patients About Taking XYREM^®

XYREM is an oral solution containing 0.5 g/mL sodium oxybate
XYREM is taken as a liquid at night
Food significantly decreases the bioavailability of XYREM
- The first dose should be taken at least 2 hours after eating
- Patients should try to minimize variability in the timing of dosing in relation to meals
Patients should not drive or operate machinery for at least 6 hours after taking XYREM
Divide XYREM starting dose into 2 equal doses (2.25 g into each dosing cup)
- Dilute each of the 2 doses with approximately 2 oz of water (60 mL, ¼ cup, or 4 tablespoons)
- Due to its short half-life, XYREM oral solution is taken in 2 equal doses at night:
  - XYREM should be titrated to effect
- Keep both doses at bedside in dosing cups with child-resistant caps
- Take the first dose while sitting up in bed, immediately before lying down to go to sleep
- Take the second dose 2½ to 4 hours later
- Patient may need to set the alarm for second dose

Patient should prepare both nighttime doses prior to bedtime.
Dosing Graphic
The effective dose range is 6 to 9 g/night

References:

^ 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.