WARNING

Oxybate sodium, also known as sodium oxybate or gamma-hydroxybutyrate (GHB), is a medication primarily used to treat narcolepsy with cataplexy. While it can be effective for managing this condition, it is important to be aware of the potential risks associated with its use. Here are some of the main risks of taking oxybate sodium:

• Central Nervous System (CNS) Depression: Oxybate sodium is a central nervous system depressant, meaning it can slow down brain activity and lead to sedation. This can cause drowsiness, dizziness, and impaired cognitive and motor functions. It is crucial to avoid activities that require mental alertness, such as driving or operating machinery, while under the influence of this medication.
• Respiratory Suppression: Oxybate sodium can suppress respiratory function, particularly when taken in higher doses or combined with other depressant substances like alcohol or sedatives. This can lead to shallow breathing, reduced oxygen levels, and in severe cases, respiratory failure.
• Abuse Potential: Oxybate sodium has a history of being abused as a recreational drug due to its euphoric and sedative effects. Misuse or overuse can result in addiction, dependence, and withdrawal symptoms upon discontinuation. It is classified as a Schedule III controlled substance in the United States due to its abuse potential.
• Drug Interactions: Oxybate sodium can interact with other medications, including sedatives, opioids, and antidepressants, leading to increased CNS depression and respiratory suppression. It is important to inform your healthcare provider about all the medications you are taking to avoid potentially dangerous interactions.
• Other Side Effects: Common side effects of oxybate sodium include nausea, headache, dizziness, vomiting, and urinary incontinence. Less frequently, it can cause confusion, hallucinations, and mood changes. Long-term use may be associated with cognitive impairment.

It is crucial to use oxybate sodium only as prescribed by a healthcare professional and to follow their instructions carefully. Regular monitoring and communication with your doctor are essential to manage the risks and maximize the benefits of this medication.

Why is this medication prescribed?

Oxybate sodium, also known as sodium oxybate or Xyrem, is a medication that is prescribed for the treatment of two medical conditions: narcolepsy with cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.

• Narcolepsy with Cataplexy: Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and a tendency to fall asleep suddenly and uncontrollably. Cataplexy is a symptom of narcolepsy in which a person experiences sudden muscle weakness or paralysis triggered by strong emotions. Oxybate sodium is prescribed to help manage the symptoms of narcolepsy with cataplexy, including excessive daytime sleepiness and cataplexy episodes. It is thought to work by increasing the levels of gamma-aminobutyric acid (GABA) in the brain, which helps regulate sleep and wakefulness.
• Excessive Daytime Sleepiness (EDS) associated with Narcolepsy: In addition to cataplexy, narcolepsy can also cause significant daytime sleepiness, making it difficult for individuals to stay awake and alert during the day. Oxybate sodium is prescribed to help reduce excessive daytime sleepiness in patients with narcolepsy.

How should this medicine be used?

Oxybate sodium, or Xyrem, is a medication that requires careful and precise use. It is typically prescribed as an oral solution and comes with specific instructions for use. Here are some general guidelines on how oxybate sodium should be used:

• Follow the Prescribing Doctor’s Instructions: It’s crucial to carefully follow the instructions provided by your prescribing doctor. They will determine the appropriate dosage and dosing schedule based on your individual needs and medical condition. Do not modify the dosage or schedule without consulting your doctor first.
• Take at Bedtime: Oxybate sodium is usually taken at bedtime. This is because it has a sedating effect and can cause drowsiness. Taking it before going to sleep helps to manage the symptoms of narcolepsy during the nighttime and improve daytime wakefulness.
• Measure Accurately: Use the dosing device provided with the medication to measure the correct amount of oxybate sodium. It is essential to measure the solution accurately to ensure the appropriate dosage is taken. Do not use a regular household spoon as it may not provide accurate measurements.
• Take on an Empty Stomach: Oxybate sodium should be taken on an empty stomach to maximize its absorption and effectiveness. It is recommended to wait at least 2 hours after eating before taking the medication, and then wait at least 1 hour after taking the medication before eating again.
• Divide Doses: Oxybate sodium is typically taken in two separate doses during the night. Your doctor will provide specific instructions on the timing and dosage for each dose. The first dose is taken at bedtime, and the second dose is taken 2.5 to 4 hours later.
• Use with Caution: Oxybate sodium is a potent medication and can cause sedation, dizziness, and impaired cognitive function. It’s important to use caution when taking it, especially during activities that require alertness, such as driving or operating machinery. Follow your doctor’s advice regarding any restrictions on certain activities while using this medication.

Remember, these guidelines provide a general overview of the use of oxybate sodium. Always follow the specific instructions provided by your doctor and read the medication guide that comes with the product for detailed information on proper usage, potential side effects, and other important considerations.

Other uses for this medicine

Oxybate sodium, also known as sodium oxybate or Xyrem, is primarily prescribed for the treatment of narcolepsy with cataplexy and excessive daytime sleepiness associated with narcolepsy. However, there may be other off-label uses of this medication that are determined by healthcare professionals based on their clinical judgment and research. Off-label use refers to the use of a medication for a purpose other than those approved by regulatory authorities. It’s important to note that off-label use should only be considered when supported by sufficient evidence and under the supervision of a healthcare professional.

What special precautions should I follow?

Regarding special precautions for the use of oxybate sodium, it’s important to consider the following:

• Restricted Distribution System: Oxybate sodium is classified as a Schedule III controlled substance due to its potential for misuse and abuse. As a result, it is subject to a restricted distribution system. This means that it is only available through certified pharmacies that are part of a specific distribution program. This is done to minimize the risk of diversion and ensure appropriate use.
• Risk of Respiratory Depression: Oxybate sodium can cause respiratory depression, which is a slowing of breathing. This risk is increased when it is taken with other medications that can also cause respiratory depression, such as opioids or sedative medications. It is important to inform your healthcare provider about all the medications you are taking, including over-the-counter drugs, herbal supplements, and any other prescribed medications.
• CNS Depressant Effects: Oxybate sodium is a central nervous system (CNS) depressant and can cause drowsiness, dizziness, and impair cognitive and motor function. It is important to use caution when engaging in activities that require mental alertness, such as driving or operating machinery. Alcohol consumption should be avoided, as it can further potentiate the CNS depressant effects.
• Respiratory and Sleep-Related Disorders: Oxybate sodium should be used with caution in individuals with respiratory conditions, such as asthma or chronic obstructive pulmonary disease (COPD), as it can affect respiratory function. It should also be used with caution in individuals with sleep-related breathing disorders, as it can exacerbate these conditions.
• Pregnancy and Breastfeeding: The safety of oxybate sodium during pregnancy and breastfeeding has not been established. It is important to discuss the potential risks and benefits with your healthcare provider if you are pregnant or breastfeeding.

These are just some of the precautions associated with the use of oxybate sodium. It is crucial to consult with a healthcare professional for comprehensive information about the medication, including any specific precautions or warnings that may apply to your individual circumstances.

What special dietary instructions should I follow?

Oxybate Sodium requires certain dietary restrictions due to the way it is metabolized in the body. It is important to follow these guidelines:

• Do not consume alcohol while taking Oxybate Sodium. Alcohol can increase the sedative effects of the medication and may cause serious central nervous system depression.
• Avoid foods high in fat content for at least 2 hours before and after taking Oxybate Sodium, as they can affect the absorption of the medication.
• Follow a low-sodium diet while taking Oxybate Sodium, as it is a sodium salt and can contribute to sodium intake. Excess sodium intake can lead to fluid retention and high blood pressure.
• Consult with your healthcare provider or a registered dietitian for personalized dietary recommendations and guidance while taking Oxybate Sodium.

What should I do if I forget a dose?

If you forget to take a dose of Oxybate Sodium, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one. It’s important to maintain the prescribed dosing intervals to ensure the medication’s effectiveness.

What side effects can this medication cause?

Oxybate Sodium, also known as Xyrem, can cause several side effects. These side effects can vary in terms of frequency and severity among individuals. It’s important to note that not everyone experiences all of these side effects, and some individuals may not experience any side effects at all. However, here are some common side effects associated with Oxybate Sodium:

• Nausea: A feeling of discomfort or queasiness in the stomach that may be accompanied by an urge to vomit.
• Vomiting: The forceful expulsion of stomach contents through the mouth.
• Dizziness: A sensation of lightheadedness, unsteadiness, or a spinning feeling.
• Headache: Pain or discomfort in the head, ranging from mild to severe.
• Bedwetting (enuresis): Involuntary release of urine during sleep, especially in individuals who did not experience bedwetting previously.
• Diarrhea: Frequent, loose, and watery bowel movements.
• Swelling of the legs or feet (peripheral edema): Accumulation of fluid causing swelling in the lower extremities.
• Increased blood pressure: Oxybate Sodium may cause a rise in blood pressure, particularly in individuals with pre-existing hypertension.
• Sleep disturbances: Oxybate Sodium is a central nervous system depressant and can affect sleep patterns, leading to changes in sleep quality or disruptions in sleep architecture.
• Central nervous system (CNS) depression: Oxybate Sodium can cause CNS depression, resulting in sedation, confusion, slowed reflexes, and impaired cognitive function.

It’s important to promptly report any side effects you experience while taking Oxybate Sodium to your healthcare provider. They can evaluate your symptoms and determine whether any adjustments to your medication regimen are necessary.

This list does not include all possible side effects. If you have concerns about specific side effects or experience any severe or persistent symptoms, please consult your healthcare provider for further evaluation and guidance.

What should I know about storage and disposal of this medication?

Storage:

• Keep oxybate sodium in its original container with the child-resistant cap tightly closed.
• Store it at room temperature, away from excessive heat, moisture, and light.
• Do not freeze the medication.
• Keep it out of reach of children and pets.

Disposal:

• Follow your local guidelines and regulations for the disposal of medications. Do not dispose of oxybate sodium in household trash or flush it down the toilet unless specifically instructed to do so.
• Some pharmacies and healthcare facilities offer programs for the safe disposal of medications. Check with your local pharmacy or waste management authorities for available options.

In case of emergency/overdose

If you suspect an emergency or overdose situation involving oxybate sodium, it is important to take immediate action. Here are the steps to follow:

• Call Emergency Services: Dial emergency services (such as 911 in the United States) or your local emergency number right away.
• Inform the Operator/Responder: Clearly state that you are dealing with a medication overdose or emergency related to oxybate sodium. Provide as much information as possible about the situation, including the medication name, strength, and dosage taken.
• Follow Instructions: Follow the instructions provided by the emergency services operator or responder. They will guide you on what to do next and may ask for additional information.

What other information should I know?

• Keep all healthcare appointments and follow-up visits as scheduled. This allows your healthcare provider to monitor your progress, adjust your dosage if needed, and address any concerns or questions you may have.
• Inform your healthcare provider about all the medications you are taking, including prescription drugs, over-the-counter medications, and dietary supplements. This helps avoid potential drug interactions and ensures the safe use of oxybate sodium.
• It is essential to take oxybate sodium exactly as prescribed by your healthcare provider. Do not change the dosage or schedule without consulting them.
• If you experience any new or worsening symptoms, side effects, or concerns while taking oxybate sodium, notify your healthcare provider promptly.

Remember, this information provides general guidance. It’s important to consult your prescribing doctor or healthcare provider for specific instructions and personalized advice regarding the storage, disposal, and emergency procedures related to oxybate sodium.