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).
|
NEWS HIGHLIGHTSMedia Articles Related to Xyrem (Sodium Oxybate)
Researcher IDs Narcolepsy as Autoimmune Disease
Source: MedicineNet Narcolepsy Specialty [2009.05.04]
Title: Researcher IDs Narcolepsy as Autoimmune Disease
Category: Health News
Created: 5/4/2009 10:38:00 AM
Last Editorial Review: 5/4/2009
Narcolepsy
Source: MedicineNet modafinil Specialty [2008.08.05]
Title: Narcolepsy
Category: Diseases and Conditions
Created: 3/4/2002
Last Editorial Review: 8/5/2008
Published Studies Related to Xyrem (Sodium Oxybate)
Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: A randomized, double-blind, placebo-controlled, multicenter clinical trial. [2009.01]
OBJECTIVE: To evaluate the safety and efficacy of sodium oxybate for management of the symptoms of fibromyalgia syndrome (FMS)... CONCLUSION: Sodium oxybate therapy was well tolerated and significantly improved the symptoms of FMS. Further study of sodium oxybate as a novel therapeutic option for FMS is warranted.
A randomized trial evaluating the effectiveness of sodium oxybate therapy on quality of life in narcolepsy. [2006.09.01]
STUDY OBJECTIVES: To evaluate the efficacy of sodium oxybate versus placebo to improve quality of life in patients with narcolepsy... CONCLUSIONS: The nocturnal administration of sodium oxybate in patients with narcolepsy was associated with statistically significant and clinically relevant improvements in functional status, an important component of quality of life.
Sodium oxybate improves excessive daytime sleepiness in narcolepsy. [2006.07.01]
STUDY OBJECTIVES: To assess the effectiveness of sodium oxybate therapy, modafinil therapy and the combination of the two for excessive daytime sleepiness in narcolepsy patients previously taking modafinil... CONCLUSIONS: Sodium oxybate and modafinil are both effective for treating excessive daytime sleepiness in narcolepsy, producing additive effects when used together. Sodium oxybate is beneficial as both monotherapy and as adjunctive therapy for the treatment of excessive daytime sleepiness in narcolepsy.
Further evidence supporting the use of sodium oxybate for the treatment of cataplexy: a double-blind, placebo-controlled study in 228 patients. [2005.09]
BACKGROUND AND PURPOSE: To measure the effect of the nocturnal administration of sodium oxybate on cataplexy in patients with narcolepsy... CONCLUSIONS: In the largest study of its kind, sodium oxybate was highly effective for the treatment of cataplexy. The improvements in cataplexy are dependent on the dosage of sodium oxybate as well on the duration of treatment. Weekly dose titration appears to be well-tolerated.
The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy. [2009.09]
BACKGROUND: Previous studies indicate that nightly sodium oxybate administration reduces nocturnal sleep disruption in narcolepsy. The present study provided an opportunity to further characterize these sleep-related effects in patients with narcolepsy during treatment with sodium oxybate as monotherapy or in combination with modafinil... CONCLUSIONS: In addition to its established efficacy for the treatment of cataplexy and EDS, nightly sodium oxybate administration significantly reduces measures of sleep disruption and significantly increases slow-wave sleep in patients with narcolepsy.
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.
|
PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Xyrem has an overall score of 5.83. The effectiveness score is 7.33 and the side effect score is 6. 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 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. |
|
| | Xyrem review by care giver of 55 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | trouble sleeping at night, tired during day |
| Dosage & duration: | | once when went to bed at 9:30,later at12 (dosage frequency: every night) for the period of a month |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The patient did wake up more refreshed in the morning and didn't have to take the usual hour - 2 hour naps after work. They didn't feel tired during the day anymore |
| Side effects: | | The treatment had very severe side effects : Extreme confusion - getting lost on the way home from work, mixing days up, not remembering how to do easy tasks like checking email. Emotional Changes - she would say "I think I am crazy" and cry. |
| Comments: | | Everything noteworthy has been described above. |
|
| | 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 |
|
|
|
Page last updated: 2009-10-20
|
