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Important Safety Information for Sodium Oxybate Oral Solution

WARNING: Taking Sodium Oxybate Oral Solution with other Central Nervous System (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.

WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE

•  Central Nervous System Depression
Sodium Oxybate Oral Solution is a Central Nervous System (CNS) depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with Sodium Oxybate Oral Solution. Many patients who received Sodium Oxybate Oral Solution during clinical trials in narcolepsy were receiving CNS stimulants.