Xyrem in Fibro patents improved EEG sleep physiology & sleep-related FM symptoms

[Otis]

The real title is: Effects of Sodium Oxybate on Sleep Physiology and Sleep/Wake-related Symptoms in Patients with Fibromyalgia Syndrome but that wouldn't fit. :Retro smile:

Sodium Oxybate is marketed currently as Xyrem.

So here's the pubmed link for the abstract.

I got to (but have not yet read) the full paper. It comes up in a frame as a PDF. It crashed my browser (Firefox) the first time I tried, but got it the second.

And finally (this has worn me out :tongue here's text of the abstract:

OBJECTIVE: To determine the effects of sodium oxybate (SXB) on sleep physiology and sleep/wake related symptoms in patients with fibromyalgia syndrome (FM). METHODS: Of 304 patients with FM (American College of Rheumatology tender point criteria) in the screened study population, 209 underwent polysomnography, 195 were randomized, and 151 completed this 8-week, double-blind, placebo-controlled study of SXB 4.5 g and 6 g/night. We evaluated changes in objective sleep measures and subjective symptoms, including daytime sleepiness [Epworth Sleepiness Scale (ESS)], fatigue visual analog scale (FVAS), sleep [Jenkins Scale for Sleep (JSS)], and daytime functioning [Functional Outcome of Sleep Questionnaire (FOSQ), SF-36 Vitality domain, and Fibromyalgia Impact Questionnaire (FIQ) general and morning tiredness].

RESULTS: Pretreatment screening revealed an elevated incidence of maximum alpha EEG-intrusion > 24 min/hour of sleep (66%), periodic limb movements of sleep (20.1% >/= 5/hour), and moderate to severe obstructive sleep apnea disorder (15.3% apnea-hypopnea index >/= 15/hour). Compared with placebo, both doses of SXB achieved statistically significant improvements in ESS, morning FVAS, JSS, FOSQ, SF-36 Vitality, and FIQ general and morning tiredness; both doses also demonstrated decreased rapid eye movement (REM) sleep (all p </= 0.040). SXB 6 g/night improved afternoon, evening and overall FVAS, reduced wakefulness after sleep onset, and increased Stage 2, slowwave, and total non-REM sleep (all p </= 0.032) versus placebo. Moderate correlations (>/= 0.40) were noted between changes in subjective sleep and pain measures. Adverse events occurring significantly more frequently with SXB than placebo were nausea, pain in extremity, nervous system disorders, dizziness, restlessness, and renal/urinary disorders (including urinary incontinence).

CONCLUSION: This large cohort of patients with FM demonstrated that SXB treatment improved EEG sleep physiology and sleep-related FM symptoms.

 

[Otis]

This looks great. I believe (need to go hunting for papers) that Xyrem also shows increases in Human Growth Hormone and decreases pain in Fibro patients.

I would have been happier if there were increases in deep sleep (slow wave, stage 3/4) rather than stage 2 and REM. I get N0 deep sleep.

FDA approval is in review for Fibro, think I saw that on about.com.

 

[sensing progress]

I also read somewhere today that there was study done on it's use for CFS patients, but not yet published.

 

[Otis]

Good to know. I suspect this will be very good for CFS patients too. My SWS problems are pretty classic Fibro (or perhaps just better studied there) and showed up at least 3 years before wicked pain.

I think Dr. Bateman has said that CFS and Fibro two ends of a continuum. I think it's more of a random blender, or perhaps that's just how it feels - falling into a blender.

 

[sensing progress]

Good to know. I suspect this will be very good for CFS patients too. My SWS problems are pretty classic Fibro (or perhaps just better studied there) and showed up at least 3 years before wicked pain.

Ahh, finally remembered where I saw it. CAA's wall on Facebook -- http://www.facebook.com/CFIDSAssn?v=wall

"A study reported in the Journal of Rheumatology indicates that twice-nightly dosing with sodium oxybate (Xyrem) helps improve sleep in fibromyalgia. A clinical trial of Xyrem in CFS has been completed by researchers at Univ. of Medicine & Dentistry of NJ, but has not yet been reported. http://jrheum.org/content/early/2010/07/29/jrheum.091041.abstract"

Interesting that it was twice-nightly doses. I guess Xyrem has a fairly short half-life?

Btw, Otis, SWS means?

 

[serenity]

thanks Otis, i'm in the same boat as you - if i can just sleep i feel so much better but i don't get any deep sleep. i'm always on the lookout for solutions.
(like your new avatar by the way)

 

[urbantravels]

Ok, how the heck does the twice-nightly dosing thing work?

I dug around and found that you have to take one dose upon going to bed and at least two hours after eating anything, and then the second dose two-four hours later. "You may have to set an alarm to wake up to take the second dose."

Yikes. That sounds like a pain.

 

[serenity]

i wouldn't have to set an alarm, without meds i wake up at least once every hour.

by the way, i have no idea where to put this so i'll choose here... my pharmacist, who i trust, wants me to go to an endocrinologist for a thyroid check. i have had this checked a couple of times, but she tells me that GP's often miss it with standard tests. so i check the symptom lists & man it would be easy to confuse thyroid with CFS. hair loss is the reason my pharm wants me to go, & i just think it's a cruel joke being played on me - the Lexapro helps me like double my energy level & overall wellness but makes my hair fall out (& i am NOT the type of woman who can get over that) ... anyway, i think it's the meds. but considering i have hair loss fatigue nightmares etc. & my mother does have thyroid problem i suppose i will listen & go see the specialist.

 

[Otis]

Ahh, finally remembered where I saw it. CAA's wall on Facebook -- http://www.facebook.com/CFIDSAssn?v=wall

"A study reported in the Journal of Rheumatology indicates that twice-nightly dosing with sodium oxybate (Xyrem) helps improve sleep in fibromyalgia. A clinical trial of Xyrem in CFS has been completed by researchers at Univ. of Medicine & Dentistry of NJ, but has not yet been reported. http://jrheum.org/content/early/2010/07/29/jrheum.091041.abstract"

Interesting that it was twice-nightly doses. I guess Xyrem has a fairly short half-life?

Btw, Otis, SWS means?

Slow Wave Sleep. Also known as Stage 3 sleep (Stages 3 and 4 have been combined but will both show up in older literature) it's where your body repairs itself and human growth hormone is released. It was shown in '75 that deprivation of SWS caused fibro-like pain after only a few nights. And I'm on (at least) six years and counting without any...

 

[LaurelW]

I used Xyrem back in 2005 for about six months when absolutely nothing else would work for sleep. I never set an alarm to wake up, would just wait until I did naturally, which was around the middle of the night. Eventually I had to switch to something else because the Xyrem would wear off in a shorter and shorter time period, and eventually it wouldn't get me through the whole night. And you absolutely can't combine it with any other sleep drugs. (sodium oxybate is one of the infamous date-rape drugs).

I'm trying to get it again, but I have different drug coverage now, and they rejected my claim because I don't have narcolepsy or cataplexy, which are the on-label conditions it's used for. I'm actually in the process of appealing their decision, and had to send them all the scientific studies I could find, plus prove I would also fall under the fibro label since that's what the studies were done on. I'm waiting for that study on CFS to get published, and I even asked the company who sells Xyrem about it since they were part of the study, but so far they've been silent.

I have a friend who was in one of the FM trials, and it really, really helped her. She said that for the first time in years, she could unload and re-load the diswasher without resting in the middle.

 

[Otis]

I used Xyrem back in 2005 for about six months when absolutely nothing else would work for sleep. I never set an alarm to wake up, would just wait until I did naturally, which was around the middle of the night. Eventually I had to switch to something else because the Xyrem would wear off in a shorter and shorter time period, and eventually it wouldn't get me through the whole night. And you absolutely can't combine it with any other sleep drugs. (sodium oxybate is one of the infamous date-rape drugs).

I'm trying to get it again, but I have different drug coverage now, and they rejected my claim because I don't have narcolepsy or cataplexy, which are the on-label conditions it's used for. I'm actually in the process of appealing their decision, and had to send them all the scientific studies I could find, plus prove I would also fall under the fibro label since that's what the studies were done on. I'm waiting for that study on CFS to get published, and I even asked the company who sells Xyrem about it since they were part of the study, but so far they've been silent.

I have a friend who was in one of the FM trials, and it really, really helped her. She said that for the first time in years, she could unload and re-load the diswasher without resting in the middle.

I hope your insurance appeal is approved. I'm not sure if you've seen this post but it may help your case. It ties CFS to narcolepsy-like sleep issues and shows significant improvements in fatigue and pain. http://www.forums.aboutmecfs.org/sh...isorder-in-chronic-fatigue-syndrome-and-fibro.

 

[Becky]

I was using Xyrem for about a year with great results. Through a sleep study, I was diagnosed with alpha intrusion. My insurance covered it for awhile, but now I would have to pay $1,600 a month to get it again. Xyrem gave me the rest I have needed for 8 years. I woke up refreshed and clear headed. My energy levels improved and I could think clearly again. The FDA did not approve Xyrem for anything other than narclepsy. Their reasoning, it is too close in formulation to other abused drugs like GHB and Rohypnol. However, since my doctor wrote the script, I could get it again if I wanted to pay for it myself. FRUSTRATING.

So the achy, feverish, foggy brain, confused thinking, headaches, blurry vision and exhaustion are all back. Thanks FDA.

No more good night sleep until I win the lottery.

 

[LaurelW]

Actually, my insurance appeal was approved. Then they told me that I'm on the brink of the donut hole, and would have to put out about $3,000 to get to the catastrophic coverage on the other side. Don't have that kind of cash. So I'm waiting till the $ resets in January since they approved me for a year. Sigh.