Do not take Sodium Oxybate Oral Solution if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol, or have a rare problem called succinic semialdehyde dehydrogenase deficiency.
Keep Sodium Oxybate Oral Solution in a safe place to prevent abuse and misuse. Selling or giving away Sodium Oxybate Oral Solution may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Anyone who takes Sodium Oxybate Oral Solution should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking Sodium Oxybate Oral Solution. Those activities should not be done until you know how Sodium Oxybate Oral Solution affects you or your child.
Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
Sodium Oxybate Oral Solution can cause serious side effects, including the following:
- Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take Sodium Oxybate Oral Solution.
- Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, and difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves. Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite.
- Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child starts sleepwalking. Your doctor should check you or your child.
Tell your doctor if you are or your child is on a salt-restricted diet or if you have or your child has high blood pressure, heart failure, or kidney problems. Sodium Oxybate Oral Solution contains a lot of sodium (salt) and may not be right for you or your child.
The most common side effects of Sodium Oxybate Oral Solution in adults include nausea, sleepiness, dizziness, vomiting, bedwetting, and tremor. The most common side effects of Sodium Oxybate Oral Solution in children include, nausea, bedwetting, vomiting, headache, weight decreased, decreased appetite, dizziness and sleepwalking. Your side effects may increase when you take higher doses of Sodium Oxybate Oral Solution. Sodium Oxybate Oral Solution can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of Sodium Oxybate Oral Solution.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see the full Prescribing Information, including Boxed Warning and Medication Guide.
Manufactured by: Jazz Pharmaceuticals plc, Dublin 4, Ireland
Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922