Safety Information

XYREM^® is a controlled substance. Controlled substances are medicines that, if abused, may lead to varying degrees of physical or psychological dependence (emotional need to take the drugs). XYREM is a Schedule III drug – which means that it has a moderate likelihood of causing dependence. Do not sell, distribute, or give your XYREM to anyone else. Do not use your XYREM for any other purpose than what it was prescribed for. If you do so, you may be punished under federal and state law by jail and fines.

Remember, your XYREM must be:

• Used only by you.
• Used only as directed by your doctor.
• Stored in a safe and secure place and at room temperature.

It is very important to keep XYREM out of reach of children and pets.

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.

While Xyrem is sodium oxybate, a form of GHB, there can be important differences between Xyrem and illegal GHB. Xyrem is approved by the FDA. It has been carefully studied in clinical trials in 717 people with narcolepsy. Xyrem is manufactured under strictly controlled conditions. The content and strength of Xyrem are regulated by the FDA. Because Xyrem has a known concentration, an appropriate dose can be determined for you by your doctor. By contrast, illegal GHB is made under uncontrolled conditions and can contain chemicals whose content, strength, and harmfulness are unknown. GHB occurs naturally in the body at very low levels, most often in the brain and spine.

XYREM can cause 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 dangeous 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 performing these activities.

You should not drink alcohol or take other medicines that cause sleepiness. You could have serious side effects.

Do not take XYREM if you take other sleep medicines or sedatives (medicines that cause sleepiness), or if you have a rare condition called succinic semialdehyde dehydrogenase deficiency.

Life-threatening breathing trouble has been reported after taking too much XYREM.

Tell your doctor if you have any of these serious side effects while taking XYREM: trouble breathing while asleep, confusion, seeing or hearing things that are not real, abnormal thinking, agitation, depression, thoughts of harming yourself or trying to harm yourself, and passing out.

Abuse and misuse of XYREM can cause serious medical problems, including seizures, passing out, coma, and death.

Tell your doctor if you start bedwetting or sleepwalking while taking XYREM.

Tell your doctor if you 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.

The most common side effects with XYREM in controlled clinical studies were feeling nauseous, feeling dizzy, headache, throwing up, feeling sleepy, bedwetting, and sore throat.

In all clinical studies, ten percent of patients dropped out of the study early because of side effects. The most common reasons for dropping out were feeling nauseous, feeling dizzy, and throwing up.

You can get XYREM only by prescription. You must get it through the central pharmacy. Before you first receive XYREM, your doctor or the central pharmacy will confirm that you understand how to use the drug safely and effectively.

You should talk with your doctor every 3 months to check how you’re doing. You may need to talk with your doctor more often when you first start taking XYREM.
Tell your doctor if you don’t feel any improvements while taking XYREM. Also tell your doctor about any side effects. He or she may need to re-check you and change your dose. Do not stop taking XYREM or change your dose without talking to your doctor first.

Download the complete XYREM Medication Guide.