I know that it is approved for Narcoleptics. I have Fibromyalgia and getting the needed deep sleep is next to impossible.
Has Xyrem been approved by the FDA for sleep treatment of Fibromyalgia?
- Posted:
- 12 Sep 2011 by gibsongirl
- Topics:
- xyrem, fibromyalgia, sleep disorders, sleep, fda
Details:
Answers (3)
suzanne6612 Sep 2011
No - the application was rejected (see link below)
Xyrem is only approved for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.
http://www.drugs.com/news/fda-worries-abuse-jazz-fibromyalgia-26186.html
http://www.foxbusiness.com/markets/2010/10/11/fda-denies-jazz-pharmaceuticals-approval-fibromyalgia-drug/
6 Dec 2011
No, not FDA approved but that doesn't mean it doesn't work miracles for the fibro sufferer. I started taking it about 7 weeks ago and I can honestly say it has been life saving. My doctor worked with the drug study that presented xyrem to the FDA and I am so fortunate to have found her. If you are like me and have tried every possible medication with zero success, I would strongly urge you to find a physician who will prescribe this for you. I have almost no pain, I haven't been sleepy during the day, I have energy I haven't had in years. I just cannot tell you the difference it's made in my life. My family and friends even notice the difference without even knowing about the medicine.
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Since my fibromyalgia was causing sleep problems for me. I had been prescribed ambien and other meds for sleep before as well as nuvigil for daytime energy. So with the sleep disorder diagnosis my insurance covers it. My monthly copay is $20. Jazz bills my insurance nearly $5000 for a month supply. Unbelievable!! I am so thankful that my insurance covers it. Your doctor has to be very committed to getting the medicine for you. My doc told me that she is the only one locally who will prescribe it for fibro. I only met her because my regular rhuemotologist was out of town. I loved her so I stayed with her and I have never been so happy that my doctor was on vacation. My husband and I were just talking about it last night. Two months ago I was popping pills all day long and still miserable because NOTHING worked. I would sleep my days away trying to catch up on sleep to no avail. I don't take any medications aside from xyrem now which is unbelievable! I just finally cleared all the bottles off my nightstand the other day. Where are you located? I'm in Texas.
Hi JReeves! Congratulations on your luck & success with finding something that's working so well for you! It sounds as if it was your destiny to find your current doctor. Fantastic!
It's almost unbelievable that you can swipe all the pill bottles off your nightstand, in one fell swoop. LOL What an exhilarating feeling! Freedom!
Please keep us all posted. There are so many people rooting for you, JR.
Thank you for giving hope to others. I see a glimmer at the end of the tunnel...
from Wendy :)