Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your healthcare professional will make. For sodium oxybate, the following should be considered:

Allergies—Tell your healthcare professional if you have ever had any unusual or allergic reaction to sodium oxybate. Also tell your healthcare professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Sodium oxybate has not been studied in pregnant women. However, studies in animals have shown that sodium oxybate may slow weight gain in baby animals. Before taking this medicine, make sure your healthcare professional knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether sodium oxybate passes into human breast milk. However, sodium oxybate is not recommended during breast-feeding because it may cause unwanted effects in nursing babies. Tell your healthcare professional if you are breast feeding.

Children—Studies in this medicine have only been done in adult patients, and there is no specific information comparing the use of sodium oxybate in children with other age groups.

Older adults—Elderly patients may be sensitive to the effects of sodium oxybate. This may increase the chance of side effects during treatment especially difficulty in movement or in thinking.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your healthcare professional may want to change the dose, or other precautions may be necessary. When you are taking sodium oxybate it is especially important that your healthcare professional and pharmacist know if you are taking any of the following:

• Central Nervous System Depressants (medicines that make you drowsy or less alert) or alcohol, especially sedatives, drugs that relax you (e.g. Valium [diazepam], Xanax [alprazolam]) or hypnotics, drugs that help you sleep (e.g. Dalmane [flurazepam])—May increase the chance of serious side effects if taken when you are using sodium oxybate

Other medical problems—The presence of other medical problems may affect the use of sodium oxybate. Make sure you tell your healthcare professional if you have any other medical problems, especially:

• Breathing problems such as:
  • Hypopnea (abnormally slow, shallow breathing) or
  • Sleep apnea (stopping breathing during sleep)
    Use of sodium oxybate may make these conditions worse

• Depression, history of, or
• Suicide, attempted—Use of sodium oxybate may worsen these conditions

• Drug abuse or dependence, history of—Dependence on sodium oxybate may be more likely to develop

• Heart failure, history, or
• Hypertension (high blood pressure) or
• Kidney problems—The amount of sodium in this medicine may make these conditions worse

• Liver problems—May increase the amount of sodium oxybate in the body and a smaller dose may be needed
  

• Succinic semialdehyde dehydrogenase deficiency (a rare, inborn metabolism deficiency)—Sodium oxybate should not be taken