By Trinka Porrata
If you have the debilitating COMBINATION of narcolepsy and cataplexy, it is possible that the “official” GHB (tradename Xyrem) might help that condition, by reducing the incidence of cataplexy. It is claimed that Xyrem reduces the incidence by 70 percent. (Comparison: an ongoing study says that Prozac reduces incidence of cataplexy by 92 percent with ongoing efficacy; but Prozac, as with most drugs, also has risks and concerns. This is not a recommendation of Prozac over Xyrem. What works for one may not work for another.).
If you have only narcolepsy or other sleep disorder—and do not have cataplexy—then Xyrem wasn’t approved for that purpose. But, since the FDA declined to exempt Xyrem from “off label use”—though this was recommended by their own advisory committee–doctors can and may prescribe it for just sleep disorders or other conditions.
While Orphan Medical can only “advertise” Xyrem for the combination of narcolepsy and cataplexy, their literature also suggests that Xyrem may be a possible treatment for daytime sleepiness and fibromyalgia, referencing that it is being researched for those conditions. The FDA has not deemed it efficacious for those conditions yet, but because of the off label use policy and the reference in their materials, doctors can and might prescribe it without being fully informed.
NOTE: Off label use means that doctors can prescribe the drug for conditions and diseases other than what the drug has been researched for and approved for, even without any research or evidence to back up that it is effective or safe for that other purpose. That is a policy fraught with risks.
Unfortunately, some of the doctors prescribing GHB for off label uses have minimal, or no, knowledge of this drug in general, other than what they have been told by a drug representative. If you are taking it or considering taking Xyrem for whatever purpose and your doctor, for example, tells you that GHB is non-addictive, you may want to get a second opinion because the medical facts indicate otherwise. Even the FDA literature on GHB acknowledges its addiction potential and withdrawal syndrome (please read the FDA data below). In fact, withdrawal from GHB, once addicted, can be severe. It is claimed that narcolepsy/cataplexy patients exhibit no withdrawal syndrome (if withdrawal is from a therapeutic dose), but patients with this condition truly have a strong motivation to maintain the correct schedule of their medications. Patients with a less complicated regime of medications to take daily may be more likely to slide into addiction, gradually adding a little to their dose or taking it more often.
While patients can receive only a limited supply each month, things can happen, ranging from a rollercoaster ride of being on it and off of it during the month (while waiting for the next batch) to drug-seeking behavior, buying illicit GHB. Some patients have been told that they can’t experience tolerance on this drug but reality indicates otherwise. Reading message boards about Xyrem use, some note that it worked OK at first and then they get a lessened response. Their dose gets increased and increased but there is a maximum allowed. Some doctors call that “adjusting the dose” and indeed that does have to happen for some to get the right effects and not too many side effects. But for those who simply find that they need more and more to get to sleep because it no longer works as well, there can be problems once they reach the top.
So–If you have a history of alcoholism or other addiction issues, you may not want to touch this drug. Never mind that GHB is being researched in Italy as a treatment for alcoholism. Bear in mind, there was a time when it was thought that morphine, for example, was a treatment for alcoholism!!! The Italian research doesn’t address “impairment” issues and GHB is definitely dramatically impairing for driving, etc. Yes, it may “cancel” the craving for alcohol but may well replace it with a craving for GHB. People trying to get off of GHB have to avoid alcohol completely at least for a few months to avoid slipping into alcohol dependence. Benzodiazepine drugs are also risky taken in combination with GHB and an easy substitute for those trying to get off of it, with a heightened risk of addiction to that drug. Many alcoholics who had been clean and sober for years started taking GHB thinking it was a “healthy” dietary supplement only to find their life spiraling downward as they fell into GHB addiction. Anyone prescribed Xyrem needs to appreciate their situation and be very careful with any combination of drugs and any indication of building tolerance or dependence.
Furthermore—If you have a history of depression, you may not want to touch this drug. Yes, is it touted as an anti-depressant on the Internet, but it seems to be only temporarily so for most. Many of our GHB addiction cases from one country in particular have involved mental health patients who turned to GHB as a last resort—other medications having failed them—only to find that the aftermath of GHB is deeper depression. We have dealt with a number of suicides involving people trying to get off of GHB, from suicide within hours of going into withdrawal (See Tyler’s story on our tragedies page) to months later, still struggling with depression and anxiety (whether or not they had prior depression issues). Even the FDA’s literature on GHB acknowledges the depression issue (see below).
It is important to note that the FDA’s website includes this notation about Xyrem: “Side effects associated with Xyrem include confusion, depression, nausea, vomiting, dizziness, headache, bedwetting, and sleepwalking. Abuse of Xyrem could also lead to dependence, i.e, craving for the medicine, and severe withdrawal symptoms.”
Many users discuss on the message boards their experiences, including vomiting, snoring, sleepwalking, concern about maybe not being able to wake up at the sound of fire alarms or whatever emergencies while on it, etc.
It is important that you discuss any side effects with your doctor. It seems, based on email and board messages that sometimes patients are reluctant to tell the doctor, fearing they’ll be kicked out of a clinical trial or taken off the medication and since they may be having some improvement on Xyrem, they are hesitant to risk giving it up. But it may be a matter of adjusting the dosage or indeed may involve danger and should be handled with the doctor.
The FDA approved medical guide for Xyrem includes this information:
What is the most important information I should know about Xyrem®?
*Xyrem® is a Schedule III, federally controlled substance. This means that if you sell, distribute, or give your Xyrem® to anyone else, or if you use your Xyrem® for purposes other than what it was prescribed for, you may be punished under federal and state law by jail and fines. Your Xyrem® should be used only by you, as prescribed.
*It is critical to keep Xyrem® out of the reach of children.
*Xyrem® can cause serious side effects including trouble breathing while asleep, confusion, abnormal thinking, depression, and loss of consciousness. Tell your doctor if you have any of these problems while taking Xyrem®.
*The active ingredient in Xyrem® is gamma-hydroxybutyrate (GHB), a chemical that has been abused (misused). Abuse can cause serious medical problems, including trouble breathing, seizures (convulsions), loss of consciousness, coma, and death. Abuse of Xyrem® could also lead to dependence, craving for the medicine, and severe withdrawal symptoms.
*Xyrem® causes sleep very quickly. Therefore, take Xyrem® only at bedtime and while in bed.
*Do not drive a car, operate heavy machinery, or perform any activity that is dangerous or that requires mental alertness for at least 6 hours after taking Xyrem®. When you first start taking Xyrem®,until you know whether it makes you sleepy the next day, use extreme care while driving a car, operating heavy machinery or doing anything else that could be dangerous or needs you to be fully mentally alert.
Who should not take Xyrem®?
Do not take Xyrem® if you
*take other sleep medicines or sedatives (medicines that cause sleepiness),
*have a rare condition called succinic semialdehyde dehydrogenase deficiency
Tell your doctor if you
*are pregnant or plan to become pregnant or are breastfeeding. It is not known whether Xyrem® can pass through your milk and harm the baby.
*have had depression. You may be more likely to get depressed taking Xyrem®.
*have liver problems. Your dose may need to be adjusted.
*have sleep apnea, snoring, or breathing or lung problems. You may be more likely to get serious side effects.
*are on a salt restricted diet, have high blood pressure, or heart failure. Xyrem® contains a lot of sodium (salt) and may not be right for you.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and supplements.
What are the possible side effects of Xyrem®?
*The most common side effects of Xyrem® are nausea, dizziness, headache, sleep problems, confusion, vomiting, and bed-wetting. Tell your doctor if you develop these less common but possibly serious side effects: sleepwalking (confused behavior during the night that may include walking around and doing other activities while not aware of what you are doing), increased sleepiness during the day, snoring, you stop breathing for a short time while you sleep (sleep apnea), breathing problems, depression, and abnormal thinking. These are not all of the side effects of Xyrem®. If you are concerned about any possible side effects consult your doctor.
Effects of abusing (misusing) Xyrem® (GHB)
*Some people who repeatedly abuse GHB become addicted to it. People who repeatedly abuse GHB can develop withdrawal symptoms. These symptoms include the need to continue taking the drug, anxiety, trouble sleeping, and abnormal thinking.
General advice about Xyrem®
Medicines are sometimes prescribed for purposes not mentioned in Medication Guides. Do not use Xyrem® for a condition for which it was not prescribed. Do not give Xyrem® to other people. It may harm them, and it is against the law.
Adverse reactions Xyrem or other GHB products (illicit products that are really GHB) or any other drugs may be reported to the FDA through their MedWatch page.
Report form begins here…
|Based on incoming email from Xyrem patients, we know that some doctors who are prescribing it are NOT screening their patients for prior addiction and depression issues. And some are prescribing Xyrem to patients who are taking other depressant drugs at the same time, etc.|
Xyrem Messages to Project GHB:
(Note: This is a partial sample of messages regarding Xyrem)
My wife had GHB (Xyrem) prescribed to her from a family medicine doctor for sleep. She took it for nearly 10 weeks… She takes other meds as well. She began to hallucinate, had psychotic fits, rage, and required hospitalization. Is it legal to prescribe this drug for sleep???
Technically it is “legal” under the “off label use policy” for a doctor to prescribe Xyrem for sleep. But it was not approved for that purpose. The FDA review committee did not deem it efficacious to reduce daytime sleepiness. The committee also recommended that this drug be exempted from “off label use” but the FDA chose not to do so. –Porrata
I have narcolepsy and have a prescription for Xyrem. While GHB has a great potential for abuse, I do not agree with much of what I read on your website. There are countless numbers of pain killers, stimulants, tranquilizers and other drugs that have genuine medicinal benefits yet can be abused like GHB. I also disagree about more research being needed merely because “it is not known why it works.” It is unknown how half the prescription drugs on the market today actually work. Just randomly look up some drugs in the PDR and you will find out. But that in itself is not a reason to refrain from taking it if a doctor feels it could help. Doctors typically weigh the possible ill effects of a drug against the possible benefits. Now days, the doctor and patient usually come to a joint decision. If you were in agony due to some disabling illness, would you not be willing to take your chances on a drug that is know to work? Would you even care if there were unknown risks if this drug brought you immediate relief? As for GHB/Xyrem being addictive, it is definitely NOT addictive when taken as prescribed by a sleep specialist. I was a participant in one of the clinical trials a few years ago. After almost two years on Xyrem, the doctor had me stop “cold turkey;” and there were no cravings or withdrawal symptoms whatsoever. As for GHB users passing out and dying, this again is from abusing GHB. If someone takes as much GHB as they desire for a good “high;” then of course they’re flirting with death. Here’s some more food for thought. Ask any doctor who is a “SLEEP SPECIALIST;” and he or she will likely tell you what a godsend this drug is for narcoleptics. But ask any other doctor about GHB and they’ll probably freak out and agree with everything on your website. Sleep specialists are far more knowledgeable about GHB than other doctors. They not only know its potential pitfalls but also know about its medicinal benefits for narcoleptics. But thank you for at least addressing the medical use of GHB for narcoleptics. I was glad to see that you did.
Response: I’m glad you were able to stop taking GHB without withdrawal. Not all patients prescribed it have been so lucky. Actually, not all sleep specialists are recommending this drug. No, I would not consider taking this drug no matter what my condition. I realize that narcolepsy/cataplexy combined makes for quite a debilitating disease, but knowing what I do about GHB I could never be persuaded to try it. My biggest concern is that some patients are given this drug without fully appreciating what it is they are being given. If they have a history of addiction to any substance or history of depression, this drug is of particular concern. –Porrata
I’m new to your web site. Some of my fellow Narcoleptics may resent me for these comments, but I have a right to my own opinion. I have a severe, disabling case of Narcolepsy, a disorder of the brain’s sleep/wake mechanism. Over the years, I’ve developed a tolerance to all of the available stimulant medications used to treat it. I’m almost a prisoner in my own home because of the constant unrelenting sleepiness. HOWEVER, I WOULD NEVER EVEN CONSIDER TRYING XYREM (GHB) UNDER ANY CIRCUMSTANCES! When I investigated the possibility of participating in a clinical study, the benefit I could expect to receive (30% improvement) did not outweigh even some of the less serious potential side effects. There was no mention of some of the more serious side effects that are mentioned on your web site. I realize that some people with serious life-threatening illnesses will try just about anything because what have they got to lose? But a person does not die from Narcolepsy, unless he/she has an accident of some sort as a result of the excessive sleepiness. The long term effects of the stimulant medications on my brain has been bad enough. But I’m certainly not willing to risk messing up what’s left of my already damaged brain. I’ll keep my half-of-a-life rather than lose it altogether!
Narcoleptics are subject to rape when a cataplexy attack occurs. Married 27 years to a narcoleptic wife, I know exactly how it happens. One of my wife’s pregnancies in her first marrage came about when her first husband took advantage of her cataplexy. My hope is Xyrem will reduce her risk of cataplexy rape.
Clinical trials showed xyrem worked and soon my wife will start it. But narcolepsy is a strange disorder, not well understood by anyone, and we do not know whether or not it will work for her. Postings in the narcolepsy mail-list have shown it worked for other narcoleptics.
Little is know about how narcolepsy works and its origins so we have to use clinical trials to test treatments. That no one knows how GHB acts on narcolepsy begs the question and is unfair. Don’t complain about not knowing how GHB works until you can post how narcolepsy works.
I was especially disturbed by your speculation that Prozac is a narcolepsy treatment. Although some anti-depressants have been prescribed, the consensus is their side effects are not proportional to the benefits derived and no one is using Prozac to treat cataplexy.
I came to your site because as a new drug, we need to have factual information about Xyrem and interactions other drugs … Loracet Plus and ACE inhibitors. But there is no evidence that you have any data beyond the existing pharmacology.
Worse, your ignorance about narcolepsy “use Prozac” and then to criticize release of GHB because:
“they [FDA] fundamentally have very limited knowledge about it. The FDA does not know its mechanism of action or what the long-terms effects may be.” July 17, 2002 press release.
This begs the question about what you [or anyone] knows about narcolepsy and destroys your credibility as a factual source about GHB and narcolepsy.
Project GHB has never said that Prozac is a narcolepsy treatment. There is a valid, long-term university-based study about Prozac as a treatment of cataplexy (most people with cataplexy also have narcolepsy but not everyone with narcolepsy also experiences cataplexy). And, certainly no one has contended that that is a “best answer” either since Prozac, like most drugs, does have issues and concerns as well). –Porrata
I am 28 years old. I have suffered from my Narcoleptic symptoms since I was 11 years old. Although I was not properly diagnosed until I was 13, the medications I take for cataplexy and Narcolepsy do not cure or fully relieve my sleepiness or loss of muscle control, but they do however lessen the severity of them. I have heard that severity of symptoms differs from patient to patient. I think I would consider myself somewhere in the middle. I read about Sandra who seems to have more severe symptoms and I also know someone personally who has a more mild case of narcolepsy than myself. I would have to agree with you about scheduling the drug on level 1. Like human cloning and stem cell research these decisions ultimately affect human lives. Let it be fully researched before it causes more harm than help. I am sided with you on that issue. GHB, by all means should be controlled.
You state that your purpose is educate people about the ABUSES of GHB. But, I gather that you are willing to allow 150,000 or more people simply “wait” when GHB can provide substantial help to them.
Your position is not only irresponsible, but if GHB is not approved for legitimate treatment, I would place the deaths of narcoleptic patients who die from preventable accidents directly at your feet.
You are quite wrong. We are concerned about those suffering from any disease especially when treatment is non-existent or hard to come by.
Our GHB addicts (we know of more than 1000 of them in more than 47 states and several foreign countries and each of them know dozens more who are addicted too) face exactly that problem too. There aren’t 150,000 people with potential value from GHB because that’s about the full population with narcolepsy, BUT only a portion of them also have cataplexy. GHB does NOT treat narcolepsy. It does NOT reduce the daytime episodes of sleepiness. That was clearly established in the FDA hearing last summer on GHB re the narcolepsy/cataplexy trials. What it does do is reduce the incidence of cataplexy attacks (complete, brief loss of muscle control). Prozac (which granted has its own risk factors) has also been found to reduce the incidence of cataplexy by 92 percent with persistent efficacy (it keeps on working). It is of value ONLY to patients with both narcolepsy and cataplexy (cataplexy by itself is really rare).
No one here has a problem with medical use of GHB staying right where it is—in tightly controlled research environment, available ONLY to narcolepsy/cataplexy patients. Once outside of that environment, it will become a disaster (even more than it already is). People with narcolepsy/cataplexy have a strong motivation to comply with instructions and maintain a tight schedule of meds. Beyond that environment, there is no such dedication. If GHB is to be approved it MUST be excluded from the “off label use” policy of the FDA that would allow any doctor to experiment with it for any purpose. Approval for one disease or condition means simply that the drug company can’t advertise it for other purposes, but doctors can play with it without any knowledge that it will work or is safe for other use. In fact, the plan presented by Orphan was NEVER to even mention that the drug is in fact GHB, but rather it is hidden in their proposed literature as sodium oxybate (an old name for GHB which is not widely known) with a tradename of Xyrem. Even the FDA evaluation committee said that if any drug should be exempted from the off label use policy it is this one. Of course, the drug company can’t make big bucks if that should happen. You see, the drug company is eager to see it go beyond those with narcolepsy/cataplexy. I’d say that’s the irresponsible view, not ours. By the way, GHB addicts seem to be the primary investors in Orphan Medical, based on their own financial community message board. GHB addicts have been accidentally in some cases diagnosed as narcolepsy/cataplexy; others have deliberately sought that status so they can get the “good stuff” if approved.
No, our position isn’t irresponsible. We’ve saved a lot of lives because of the information provided and have helped hundreds of GHB addicts escape its grip. Meanwhile many others are struggling to get free of it while we are working to educate treatment people and others to recognize the problem and understand the unique and long treatment involved (compared to 3-5 day detoxes from most other drugs this one is much tougher). There are more than 225 GHB-related deaths reported to us, many from GHB only (no other co-ingestants). We have reason to believe that is the tip of the iceberg since most coroners know nothing about it and don’t have the ability to test for it. We have helped hundreds of addicts and know of thousands and thousands of overdoses and sexual assaults. There are more than 11,000 reported overdoses via the Drug Abuse Warning Network………….but according to one survey, only 7 percent of overdose cases get any medical treatment (and thus may be counted) because of the myth that it’s OK to “just let them sleep it off.” Well, most people do sleep off a GHB overdose… …… ….Those that don’t are called dead.
We also see a lot of accidental overdoses and suicides in people coming
off of GHB. Even Orphan admitted that they had a suicide and two attempts in their studies, but kissed it off totally to “prior depression.” That’s funny, their protocols require exclusion of people with mental health issues. And, we see that prior depression/mental health issues only make it worse. We have suicides and attempts from people with ZERO prior issues and no real world reasons to commit suicide……it’s part of the risk of withdrawal. This is a very dangerous and bizarre drug.
The National Institute of Drug Abuse recently released millions of dollars for research on GHB because so little is actually known about how it works. Approval of this drug NOW, before that essential research is done, is insane. Many countries around the world are just now awakening to the extent of their problems with GHB and are moving away from it. How inappropriate for this country to suddenly embrace it with the new info just coming to light. Look at all the recent drug issues because the FDA has inappropriately approved drugs too rapidly. The FDA should leave GHB where it is now……research status….. ……and wait for the data to be completed. Anything less than that is irresponsible. (This is the response given in 2002. The FDA approved Xyrem that summer.)