Xyrem

Xyrem is a prescription medication used to treat daytime sleepiness and cataplexy (sudden loss of muscle strength) in people who have narcolepsy.

Xyrem belongs to a group of drugs called central nervous system depressants. The exact way this medication works for narcolepsy is unknown.

This medication comes in liquid form and is taken once at bedtime, then once more 2.5 to 4 hours later.

Common side effects include nausea, dizziness, drowsiness, and headache.

Do not drive or operate heavy machinery until you know how Xyrem will affect you. Do not drink alcohol while taking Xyrem.

Xyrem is a prescription medicine used for the treatment of narcolepsy, to:

• reduce daytime sleepiness
• reduce cataplexy (weak or paralyzed muscles) attacks

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Jazz Pharmaceuticals, Inc.

• Orphan Medical, Inc

Xyrem can cause serious side effects, including:

• breathing problems. These can include decreased breathing, trouble breathing and sleep apnea (short periods of no breathing while sleeping). Patients that already have breathing or lung problems have a higher chance for breathing problems with Xyrem.

• mental health problems. Call your doctor right away if you have:
  • confusion
  • psychosis (seeing or hearing things that are not real)
  • abnormal thinking
  • agitation
  • depression
  • thoughts of killing yourself or try to kill yourself

• bedwetting. Call your doctor if you get this side effect. Your doctor should check you.

• sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start sleepwalking. Your doctor should check you.

The most common side effects with Xyrem are nausea, dizziness, and headache, vomiting, sleepiness and bed-wetting. An increase in side effects may happen with higher doses.

These are not the only possible side effects with Xyrem. If you are concerned about any possible side effects with Xyrem, talk with your doctor.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines to help you sleep (sedatives) or if you use alcohol. See FDA Warning.

Xyrem can cause serious side effects including slow breathing or changes in your alertness. Do not drink alcohol or take medicines intended to make you fall asleep while you are taking Xyrem because they can make these side effects worse. Call your doctor right away if you have any of these serious side effects. 

The active ingredient of Xyrem is a form of gamma-hydroxybutyrate (GHB). GHB is a chemical that has been abused and misused. Abuse and misuse of Xyrem can cause serious medical problems, including: 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xyrem there are no specific foods that you must exclude from your diet when receiving this medication. However, alcohol should be avoided. See FDA Warning.

Tell your doctor if you:

• have or had depression or tried to harm yourself. You should be watched carefully for new symptoms of depression.
• have liver problems. Your dose may need to be adjusted.
• have sleep apnea, snoring, breathing, or lung problems. You may have a higher chance of serious breathing problems with Xyrem.
• are on a salt-restricted diet, have high blood pressure, heart failure, or kidney problems.Xyrem contains a lot of sodium (salt) and may not be right for you.
• are pregnant or plan to become pregnant. It is not known if Xyrem can harm your unborn baby.
• are breastfeeding. It is not known if Xyrem can pass through your milk. Talk to your doctor about the best way to feed your baby if you take Xyrem.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and supplements. Especially, tell your doctor if you take other medicines to help you sleep (sedatives). Sedatives should not be used with Xyrem.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Xyrem falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

It is not known if Xyrem crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Xyrem.

Take Xyrem exactly as prescribed by your doctor.

• Take Xyrem two times each night or as directed by your doctor. Prepare your Xyrem doses before going to bed. Take the first dose at bedtime while in bed. Take your second dose 2 ½ (2.5) to 4 hours after the first dose. You should set an alarm clock to make sure you wake up to take the second dose. If you miss the second dose, skip that dose and do not take Xyrem again until the next night. Never take two Xyrem doses at once.
• Allow at least 2 hours after eating before taking Xyrem. Food will lower the amount of Xyrem that passes into your body.
• In case of accidental overdose, call 911.
• You should see your doctor every 3 months for a check-up while taking Xyrem. Your doctor should check your response to Xyrem treatment, including improvement in your symptoms and if you are having any side effects.

All Xyrem prescriptions are processed by a central, mail order pharmacy. 

Directions for Using Xyrem

• Never leave your Xyrem in a place where children or pets can get to it.
• Your Xyremmshipment will contain 1 or more bottles of medicine, 2 dosing cups with child-resistant caps, and a liquid measuring device.
• Remove the Xyrem bottle and the measuring device from the box.
• Remove the measuring device from the wrapper.
• Remove the bottle cap by pushing down while turning the cap counterclockwise (to the left).
• After removing the cap, set the bottle upright on a tabletop.
• While holding the bottle in its upright position, insert the tip of the measuring device into the center opening on top of the bottle and press down firmly.
• While holding the bottle and measuring device down with one hand, draw up the prescribed dose with the other hand by pulling on the plunger. Note: Medicine will not flow into the measuring device unless you keep the bottle in its upright position.
• Remove the measuring device from the center opening of the bottle. Empty each Xyrem dose into a dosing cup, then add about 2 ounces of water (60mL, ¼ cup, or 4 tablespoons) to each cup.
• Prepare both doses before bedtime. Place the caps provided on the dosing cups and turn each cap clockwise (to the right) until it clicks and locks into its child-resistant position.
• Recap the Xyrem bottle and store it in a safe and secure place (locked up if needed), out of the reach of children and pets. Rinse out the liquid measuring device with water.
• Right before going to sleep, place your second dose in a secure location near your bed. Set an alarm to go off 4 hours after your first dose to wake you up for your second dose. If you wake up before the alarm and it has been at least 2 ½ (2.5) hours, turn off your alarm and take your second dose.
• Remove the cap from the first dosing cup by pressing down on the child-resistant locking tab and turning the cap counterclockwise (to the left).
• Drink all of the first dose right before bedtime.
• When you wake up 2 ½ (2.5) to 4 hours later, remove the cap from the second dosing cup. While sitting in bed, drink all of the second dose right before lying down to continue sleeping. Recap the second cup.

If you take too much Xyrem, seek emergency medical attention right away.

• Always store Xyrem in the original bottle in a safe and secure place, out of the reach of children and pets.
• Keep Xyrem at room temperature, between 59° and 86° F.
• When you have completed using a bottle of Xyrem, pour any unused Xyrem down the drain, cross out the label with a marker, and place the empty bottle in the trash.
• Always place your nightly doses of Xyrem safely out of the reach of children and pets.

WARNING: Central nervous system depressant with abuse potential. Should not be used with alcohol or other CNS depressants.

Xyrem 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 Xyrem 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).

This medication is available through 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 Xyrem, 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 Success Program also recommends patient follow-up every 3 months. Physicians are expected to report all serious adverse events to the manufacturer.