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Xyrem (Sodium Oxybate) - Summary

 


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BOX WARNING

!WARNING: Central nervous system depressant with abuse potential. Should not be used with alcohol or other CNS depressants.

Sodium oxybate is 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. (See WARNINGS).

 

XYREM SUMMARY

Xyrem® (sodium oxybate) oral solution
CIII

Xyrem (sodium oxybate) is a central nervous system depressant that reduces excessive daytime sleepiness and cataplexy in patients with narcolepsy. Sodium oxybate is intended for oral administration.

Xyrem (sodium oxybate) oral solution is indicated for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.

In Xyrem clinical trials, approximately 80% of patients maintained concomitant stimulant use (see BLACK BOX WARNINGS).


See all Xyrem indications & dosage >>

XYREM NEWS HIGHLIGHTS

Media Articles Related to Xyrem (Sodium Oxybate)

Jazz Pharmaceuticals And UCB Announce Positive Phase III Results For Sodium Oxybate In Fibromyalgia
Source: Pain / Anesthetics News From Medical News Today [2008.11.21]

Narcolepsy
Source: MedicineNet Sleep Aids And Stimulants Specialty [2008.08.05]

more >>

Published Studies Related to Xyrem (Sodium Oxybate)

A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy. [2006.09.01]

Sodium oxybate improves excessive daytime sleepiness in narcolepsy. [2006.07.01]

Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients. [2005.09]

Sodium oxybate: efficacy, safety and tolerability in the treatment of narcolepsy with or without cataplexy. [2008.03]

Treatment of drop attacks in Coffin-Lowry syndrome with the use of sodium oxybate. [2007.11]

more >>

Clinical Trials Related to Xyrem (Sodium Oxybate)

Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD) [Active, not recruiting]

Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia [Completed]

Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients [Completed]

Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy [Completed]

Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes [Completed]

more >>

XYREM PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Xyrem has an overall score of 6. The effectiveness score is 7 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
 

Xyrem review by 57 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   sleep disorders
Dosage & duration:   400 mg taken nightly, 2 does for the period of one week
Other conditions:   none
Other drugs taken:   Ritalin, Mirapex, C-PAP machine
  
Reported Results
Benefits:   I ahve three sleep disorders: sleep apnea due to closing up of my throat (anatomical), restless leg syndrome and the worst one, hypersomnia -- tired much of the time with no explanation. I tried this drug - sent directly to the home and only with approved diagnosis (I am just short of narcolepsy) - to see if I would feel rested when I awoke. I did for one day but then the effects did not continue with each successive night. Sounds strange, I know, but that is what happened.
Side effects:   I did not have any side effects except that if I got less than 4 1/2 hours of sleep after waking to take the second dose - I would stillfeel the effects -- as if drugged a bit.
Comments:   I think I have included everything above. I tried a second week and felt a slight refreshed feeling upon awakening - but not significant ewnough to keep taking it. Understand, I only remember awakening refreshed 3 times in my life. one of them after that first night I used Xyrem. I have enough to try a third week and probably will -- since I am desperate for my former qualilty of life when I didn't struggle with feeling tired as I do now.

 

Xyrem review by 34 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   3mg taken daily for the period of 6 months
Other conditions:   bipolar disorder
Other drugs taken:   prozac, seroquel, lamictal, topamax, trileptal
  
Reported Results
Benefits:   While taking Xyrem, I slept exceptionally well at night, woke up rested, and strangely, within months of starting the medication, lost fifteen or more pounds.
Side effects:   Some nights I felt significant joint pain, primarily in my elbows and my shoulders. Other nights I suffered night sweats so severe that I would have to change out of my wet pajamas. On occasion when falling asleep I would feel very giddy, almost "high."
Comments:   Lack of sleep severely impacts my mood and none of the other sedative medications that I had tried worked, so I tried xyrem with beneficial effects.

See all Xyrem reviews / ratings >>

Page last updated: 2008-11-21

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