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Sodium oxybate is a potent central nervous system depressant, carrying significant risks that require cautious use. This medication is strictly to be used as prescribed by your healthcare provider and is illegal to use for any other purposes. Below are important safety considerations and warnings regarding its use:

• Risk of Abuse and Misuse: Sodium oxybate is classified as a Schedule III controlled substance due to its potential for misuse, which can lead to severe consequences such as seizures, slowed breathing, addiction, and even death. It is crucial to adhere to the dosing instructions provided by your healthcare provider. Misuse can increase the risk of life-threatening side effects.

• REMS Program Requirement: In the United States, sodium oxybate is available only through the Xyrem REMS and Lumryz REMS programs. Enrollment in these programs is mandatory for you, your healthcare provider, and your pharmacy to ensure safe usage of the medication. If you are outside the United States, consult your healthcare provider for your country's specific regulations.

• Breathing and Alertness Concerns: This medication can significantly slow breathing, posing a life-threatening risk. Symptoms such as shortness of breath, slow or shallow breathing, and bluish lips, fingers, or toes require immediate medical attention. The risk is higher if you consume alcohol, take other CNS depressants, or have a history of breathing issues like sleep apnea.

• Mental Health Effects: Use of sodium oxybate can lead to behavioral changes, including confusion, hallucinations, paranoia, aggression, depression, or suicidal thoughts. If you have a history of mental health conditions, inform your healthcare provider and monitor for any changes in behavior or mood. Immediate medical attention is necessary if you experience suicidal thoughts.

• Sleep Disorders: Some individuals may experience sleepwalking or other sleep-related disorders while taking sodium oxybate, which could lead to injury. It is important for your family to be aware of this potential side effect to help ensure your safety.

• High Sodium Content: Sodium oxybate contains a significant amount of sodium, which may be harmful for individuals with conditions such as congestive heart failure, high blood pressure, or kidney problems. It is important to discuss your full medical history with your healthcare provider, especially if you are on a low sodium diet.

• Contraindications: Sodium oxybate should not be used if you are taking other sedative medications, consuming alcohol, or have a genetic condition known as succinic semialdehyde dehydrogenase deficiency.

If you experience an overdose or severe side effects, seek emergency medical assistance immediately. Always consult your healthcare provider for further guidance and clarification regarding the use of sodium oxybate.

When taking this medication, some individuals may experience common side effects such as nausea, dizziness, vomiting, drowsiness, and bedwetting. These effects are generally mild and tend to subside over time. Should they persist or worsen, contact your healthcare provider for guidance. It's also possible to experience increased sweating, stomach pain, diarrhea, or headaches.

There are other side effects that, while less common, still occur in some users. These include tremors, poor appetite, and weight loss. If you notice any of these effects, particularly if they become severe, it's important to reach out to your healthcare provider.

Serious side effects, though rare, need prompt medical attention. Be aware of symptoms such as mental or mood changes, confusion, psychosis, hallucinations, sleepwalking, or thoughts of suicide. Additionally, if you experience difficulty breathing, especially during sleep, seek help immediately. Although an allergic reaction to this drug is uncommon, symptoms like rash, itching, swelling, severe dizziness, or trouble breathing require urgent care. Always stay attentive to how your body responds to the medication and consult with your healthcare provider if you have any concerns.

When taking Sodium Oxybate, it is important to be aware of potential drug interactions that could increase the risk of serious side effects like severe drowsiness or breathing difficulties. This risk is heightened if Sodium Oxybate is combined with other medications or substances that can cause drowsiness or respiratory issues. It is crucial to inform your doctor or pharmacist about all other medications and supplements you are using, including those available over-the-counter, as well as vitamins and herbal products.

Specifically, avoid using Sodium Oxybate with certain medicines: Carbinoxamine, Chloral Hydrate, Diphenhydramine, Doxylamine, Eszopiclone, Ethchlorvynol, Hydroxyzine, Promethazine, Ramelteon, Zaleplon, Zolpidem, and Zopiclone. These combinations are generally not recommended, and your healthcare provider might opt to adjust your treatment plan.

In some situations, it may be necessary to use Sodium Oxybate with other medications that are typically not recommended due to interaction risks. If this occurs, dosage adjustments or changes in how often you take one or both medicines may be required. Medications that fall into this category include, but are not limited to, Alprazolam, Codeine, Hydrocodone, Lorazepam, and Cyclobenzaprine. Always check the labels of any medication you are considering, particularly allergy or cold remedies, as they might contain ingredients that contribute to drowsiness. Your pharmacist can provide guidance on the safe use of these products.