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).
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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).
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NEWS HIGHLIGHTSMedia Articles Related to Xyrem (Sodium Oxybate)
Narcolepsy
Source: MedicineNet modafinil Specialty [2010.08.10]
Title: Narcolepsy
Category: Diseases and Conditions
Created: 3/4/2002 12:00:00 AM
Last Editorial Review: 8/10/2010 12:00:00 AM
Published Studies Related to Xyrem (Sodium Oxybate)
Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double-blind, placebo-controlled study. [2011.05]
This 14-week, phase 3, double-blind, randomized, controlled trial evaluated sodium oxybate (SXB) 4.5 and 6g per night versus placebo in patients with fibromyalgia (FM)...
A 2-week, polysomnographic, safety study of sodium oxybate in obstructive sleep apnea syndrome. [2011.01]
PURPOSE: Sodium oxybate (SXB) is approved for cataplexy and excessive daytime sleepiness in narcolepsy. Obstructive sleep apnea syndrome (OSAS) affects approximately 9-50% of narcoleptics. Effects of 2-week SXB administration on apnea-hypopnea index (AHI), oxygen saturation (SaO(2)), and sleep architecture were investigated in OSAS patients... CONCLUSIONS: Short-term use of 4.5 g/night SXB did not generate respiratory depressant effects in OSAS patients as measured by AHI, obstructive apnea events, central apneas, and SaO2. Extended use of SXB in higher therapeutic doses in OSAS has not been studied, and merits caution.
The nightly use of sodium oxybate is associated with a reduction in nocturnal sleep disruption: a double-blind, placebo-controlled study in patients with narcolepsy. [2010.12.15]
CONCLUSIONS: The nightly administration of SXB to narcolepsy patients significantly impacts measures of slow wave sleep, wake after sleep onset, awakenings, total sleep time, and stage 1 sleep in a dose-related manner. The frequency and severity of narcolepsy symptoms decreased with treatment.
Enhancing slow wave sleep with sodium oxybate reduces the behavioral and physiological impact of sleep loss. [2010.09]
STUDY OBJECTIVES: To investigate whether enhancement of slow wave sleep (SWS) with sodium oxybate reduces the impact of sleep deprivation... CONCLUSIONS: Pharmacological enhancement of SWS with sodium oxybate resulted in a reduced response to sleep loss on measures of alertness and attention. In addition, SWS enhancement during sleep restriction appears to result in a reduced homeostatic response to sleep loss.
A safety trial of sodium oxybate in patients with obstructive sleep apnea: Acute effects on sleep-disordered breathing. [2010.01]
OBJECTIVE: Sodium oxybate (SXB) is an approved drug for the treatment of excessive daytime sleepiness (EDS) and cataplexy in narcolepsy. Obstructive sleep apnea syndrome (OSAS) is a condition that frequently co-occurs with narcolepsy. Given the known central nervous system (CNS) depressant effects of SXB, this study aimed to examine its effects on sleep-disordered breathing (SDB) and sleep architecture in patients with OSAS... CONCLUSION: These results suggest that nighttime administration of 9g SXB in patients with mild to moderate OSAS does not negatively impact SDB, as measured by mean change from baseline in AHI and SaO(2), but might increase central apneas and cause oxygen desaturation in some individuals and should be used with caution. Copyright 2009 Elsevier B.V. All rights reserved.
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]
This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for
the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in
patients with mild to moderate Parkinson's Disease (PD).
Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia [Completed]
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when
used alone to treat the pain and sleep disturbances of fibromyalgia.
Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients [Completed]
To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the
morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and
outcome of events of sleep-disordered breathing in patients with obstructive sleep apnea
syndrome (OSAS).
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy [Completed]
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled,
parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will
be required to make 5 visits over up to 14 weeks to a participating expert physician
practitioner for various sleep and narcolepsy evaluations and diaries will also be collected.
Participants will take assigned medications during the course of the trial. Subjects will
have a 25% probability of receiving placebo for both drugs (modafinil and Xyrem). All
subject volunteers must meet criteria for narcolepsy and have evidence of daytime sleepiness.
Patients will not incur any personal medical expenses due to participation in this trial.
The sponsor is covering all visit costs not covered by insurance and there are some funds for
patient expenses such as travel.
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes [Completed]
To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus
on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine
changes.
Reports of Suspected Xyrem (Sodium Oxybate) Side Effects
Fall (129),
Nausea (113),
Insomnia (111),
Somnolence (103),
Weight Decreased (98),
Condition Aggravated (94),
Fatigue (92),
Vomiting (77),
Dizziness (74),
Headache (72), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 9 ratings/reviews, Xyrem has an overall score of 6.89. The effectiveness score is 7.78 and the side effect score is 6.22. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Xyrem review by 40 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Insomnia |
| Dosage & duration: | | 6g nightly (3.25/2.75) (dosage frequency: nightly) for the period of 3 months |
| Other conditions: | | Depression & Anxiety |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | After suffering with chronic insomnia for the majority of my adult life, and after all of the popular sleep meds failed, I found Xyrem and it has changed my life. I am now in control of when I go to sleep and when I wake. The depression (Beck Index: 28) vanished after 3 weeks of treatment (Beck Index: 5). Anxiety has also abated. Loss of fat, increase in muscle size and strength. Improved energy. Improved interaction with friends and family. |
| Side effects: | | During the first 2 weeks there was stomach irritation, increased sweating at night, and diminished appetite. All have abated now. |
| Comments: | | I take 3.25g at bedtime, usually 10:30 PM. This normally produces sleep until about 2:00 AM. I then take another 2.75g dose and sleep until 5:30 AM. On average, I get 5.5 to 7 hours of sleep and it is the best sleep I have ever known. I no longer stay awake for days on end and I never have to come home on my lunch break to nap.
With the exception of the outrageous price, Xyrem is an amazing treatment for insomnia. It is a shame that the media has turned such a wonderful treatment into an evil 'date rape drug'. |
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| | Xyrem review by 32 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Narcolepsy/Cataplexy |
| Dosage & duration: | | 3.0 g (dosage frequency: twice at night) for the period of 2 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Before taking Xyrem I had to take a daily nap to feel refreshed. I had vivid hallucinations and I had to control my emotions.I would also get up to use the restroom approximately 10 times at night. Since i started taking Xyrem, I stopped taking those daily naps, no more hallucinations and I am able to laugh;cry more with less muscle weakness. Eventhough I only sleep for 6-7 hours max, I wake up feeling refreshed. |
| Side effects: | | When I take the first dose I noticed that I dont have trouble falling asleep. When I take my second dose 3-4 hours later,I am super dizzy. If I need to use the restroom I have to hold on and hurry back to bed. |
| Comments: | | I take my first dose (3.0 g) around 11 pm. take second dose around 3 am. I wake up like around 6 am. I want to stay in bed for more but cant. I am not sleepy. There are mornings were I am still feeling groggy, and by noon i would be okay to do my daily chores. |
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| | Xyrem review by 39 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | unrestful sleep, narcolepsy? |
| Dosage & duration: | | 3g (dosage frequency: 2 times a night) for the period of 2 weeks |
| Other conditions: | | insomnia |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I sometimes wake up refreshed although with xyrem I only sleep for about 5 hrs every night |
| Side effects: | | Night sweats. waking up too early. Getting unrefreshed sleep every other night |
| Comments: | | I have been taking Xyrem for about 2 months. I sleep about 5 to 5 1/2 hours every night. I wake up between 3 to 3 1/2 hour after the 1st dose and then I sleep for about 2 to 2 1/2 hours after the 2nd dose and am unable to fall asleep. The weirdest thing is that I get a refreshing sleep every other day. On the days that I wake up exhausted, I am barely able to make it through the day and am hungry all the time. The next night, I usually sleep well and have a better day there after. I am going to stop taking it and I am going to explore other options such as Rozerem or Trazodone |
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Page last updated: 2011-12-09
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