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Xyrem—Wonder Drug or Drug of Concern???
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. For anyone taking it or considering it, this link provides a series of links to the discussions about Xyrem use.
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.