When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to sodium oxybate, or have succinic semialdehyde dehydrogenase deficiency.

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.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Take this medicine on an empty stomach or at least 2 hours after you eat.
• Measure the medicine with the marked plastic syringe that came 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.
• This medicine will make you drowsy very quickly. Take it only at bedtime when you are ready to fall asleep. Stay in bed after you take the first dose.
• 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.
• 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.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not freeze.
• Pour any unused medicine down the sink drain. Use a marker to cross out the label on the bottle. Then, place the empty bottle 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 medicine that makes you sleepy, such as 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, breathing problems (such as hypopnea, sleep apnea), heart failure, high blood pressure, or a history of depression 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
• 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 the second dose of 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, and cold, clammy skin
• Sleepwalking

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

• Bedwetting
• 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