Sodium Oxybate (SOE-dee-um OX-i-bate)

Treats sudden onset of weak or paralyzed muscles, or excessive daytime sleepiness in patients with narcolepsy.

Brand Name(s):

Lumryz, Xyrem

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Solution:
  • This medicine is divided into 2 nightly doses.
  • Measure the medicine with the marked plastic syringe that comes with the medicine. Mix the medicine with 2 ounces (1/4 cup) of water. Mix both doses before you go to bed. Store the second dose close to your bed, out of the reach of children.
  • Take the second dose 2 1/2 to 4 hours after you take the first dose. You may need to set an alarm clock to wake you up so you can take the second dose on time.
  • Use the medicine within 24 hours after it has been mixed with water.
• Extended-release suspension (packet):
  • Open the mixing cup and fill it with water up to fill line A. Put the mixing cup down on a flat surface.
  • Use scissors to cut the packet open along the cutting line or tear the packet open with your hands.
  • Empty the entire contents of a packet into the mixing cup. Shake the mixture well for at least 60 seconds. The mixture will look slightly milky with some lumps.
  • Drink the mixture within 30 minutes of mixing while sitting in bed.
  • If some medicine remains in the cup, add more water up to fill line B, shake for 10 seconds, and drink immediately.
  • Leave the mixing cup at your bedside and lie down immediately to go to sleep.
• Take this medicine at least 2 hours after you eat.
• This medicine can make you sleep very quickly (within 5 to 15 minutes) without feeling drowsy. It is best to take the medicine only at bedtime or when you are ready to fall asleep.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss the second dose, skip that dose and do not take any more medicine until the next night. Do not use extra medicine to make up for a missed dose.
• Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Pour any unused medicine down the sink drain. Use a marker to cross out the label on the bottle, then throw it in the trash.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not drink alcohol while you are using this medicine. Do not use this medicine if you are also using a sedative medicine.
• Some medicines can affect how sodium oxybate works. Tell your doctor if you are using any of the following:
  • Divalproex sodium
  • Medicine to treat depression or mental illness
  • Any other medicine that makes you sleepy, including sleeping pills, cold and allergy medicine, or narcotic pain medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung or breathing problems (including hypopnea, sleep apnea), heart failure, high blood pressure, or a history of depression, or alcohol or drug abuse. Tell your doctor if you are on a low-salt diet.
• This medicine may cause the following problems:
  • Serious breathing problems (which can be life-threatening)
  • Changes in mood or behavior
  • Sleeping problems, including sleepwalking, which can cause injuries
• This medicine may make you dizzy, drowsy, or less alert. Do not drive or do anything else that could be dangerous for at least 6 hours after you take this medicine.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Depression, anxiety, confusion, unusual behaviors, seeing or hearing things that are not there, thoughts of hurting yourself
• Extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, cold, clammy skin
• Sleepwalking

If you notice these less serious side effects, talk with your doctor:

• Bedwetting
• Decreased appetite, weight loss
• Headache, dizziness, drowsiness
• Nausea, vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088