Symptoms of Narcolepsy

Prevalence

  • Affects approximately 1 in 2,000 Americans[1][2]
  • The third most frequently diagnosed primary sleep disorder at sleep clinics[1]

Symptoms of Narcolepsy

XYREM® (sodium oxybate) is not approved for DNS, hypnagogic/hypnopompic hallucinations, or sleep paralysis.

Source: [2][3][4][5][6][7]

References:

  1. ^ National Institute of Neurological Disorders and Stroke. Narcolepsy Fact Sheet. Available at: http://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm. Accessed February 6, 2007.
  2. ^ Mahmood M, Black J. Narcolepsy-cataplexy: how does recent understanding help in evaluation and treatment. Curr Treat Options Neurol. 2005;7:363–371.
  3. ^ Bassetti C, Aldrich MS. Narcolepsy. Neurol Clin. 1996;14:545–571.
  4. ^ American Academy of Sleep Medicine. The International Classification of Sleep Disorders, Revised: Diagnostic and Coding Manual. Westchester, Ill: American Academy of Sleep Medicine; 2001.
  5. ^ Chaudhary BA, Husain I. Narcolepsy. J Fam Pract. 1993;36:207–213.
  6. ^ Overeem S, Mignot E, van Dijk JG, Lammers GJ. Narcolepsy: clinical features, new pathophysiologic insights, and future perspectives. J Clin Neurophysiol. 2001;18:78–105
  7. ^ Thorpy M. Current concepts in the etiology, diagnosis and treatment of narcolepsy. Sleep Med. 2001;2:5–17

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.