WARNING

Taking Xyrem (sodium oxybate) involves certain risks, and individuals should be aware of potential adverse effects and considerations:

• Respiratory Depression: Xyrem is a central nervous system depressant and can lead to respiratory depression, particularly if combined with other substances like alcohol or other central nervous system depressants.
• Sedation and Dizziness: Xyrem can cause sedation and dizziness. It’s important to use caution when engaging in activities that require mental alertness, such as driving or operating machinery.
• Seizures: Xyrem may lower the seizure threshold, increasing the risk of seizures, especially in individuals with a history of seizures.
• Depression and Suicidal Ideation: Some individuals taking Xyrem have reported depression and suicidal thoughts. Monitoring for changes in mood is essential.
• Hypersensitivity Reactions: Allergic reactions, including rash, hives, and swelling, have been reported in some individuals using Xyrem.
• Sleepwalking and Sleep-Related Behaviors: Xyrem has been associated with an increased risk of sleepwalking and other complex sleep-related behaviors. These behaviors may occur without any memory of the event.
• Potential for Abuse and Dependence: Due to its potential for abuse, Xyrem is only available through a restricted distribution program. Misuse or unauthorized use can lead to serious health risks.
• Interaction with Alcohol: Alcohol should be avoided while taking Xyrem, as the combination can increase the risk of respiratory depression and other serious side effects.
• Sodium Content: Xyrem contains sodium, and in some cases, it may lead to sodium retention, which can be a concern for individuals with certain health conditions.

It’s crucial for individuals prescribed Xyrem to follow their healthcare provider’s instructions carefully, including dosage recommendations and precautions. Regular monitoring, open communication with healthcare providers, and adherence to safety guidelines are essential for managing the risks associated with Xyrem use. If there are concerns or if any side effects occur, individuals should promptly seek advice from their healthcare provider.

Why is this medication prescribed?

Xyrem (sodium oxybate) is a prescription medication used to treat two symptoms of narcolepsy: cataplexy and excessive daytime sleepiness. Narcolepsy is a chronic neurological disorder that affects the control of sleep and wakefulness.

• Cataplexy: Cataplexy is a sudden and temporary loss of muscle strength, often triggered by emotions such as laughter, excitement, or surprise. Xyrem can help reduce the frequency and severity of cataplexy attacks.
• Excessive Daytime Sleepiness: Xyrem can also help improve excessive daytime sleepiness, a common symptom of narcolepsy.

How should this medicine be used?

Xyrem is a central nervous system depressant, and its active ingredient is gamma hydroxybutyrate (GHB). It is taken orally, and it’s typically administered in two doses during the night. The medication helps regulate sleep patterns and improve the quality of nighttime sleep.

How to Use Xyrem:

• Dosage: Your doctor will determine the appropriate dosage based on your individual needs. The dosage is usually divided into two equal doses, with the second dose administered 2.5 to 4 hours after the first dose.
• Administration: Xyrem is a liquid medication that should be mixed with water just before taking. It is taken by mouth using an oral syringe provided by the pharmacy.
• Timing: The doses are taken at bedtime and during the night. The first dose is taken at bedtime, and the second dose is taken 2.5 to 4 hours later.
• Empty Stomach: Xyrem should be taken on an empty stomach, at least 2 hours after eating.
• Avoid Alcohol: It is important to avoid alcohol while taking Xyrem, as alcohol can increase the risk of serious side effects.
• Regular Monitoring: Your doctor will monitor your response to Xyrem and may adjust the dosage as needed.

It’s crucial to follow your doctor’s instructions and the provided dosing schedule carefully. Xyrem is a powerful medication, and its use should be closely supervised by a healthcare professional due to the potential for abuse and the risk of serious side effects if not taken as directed. It is important to discuss any concerns or questions about the medication with your healthcare provider.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you think this drug may be recommended for other conditions.

What special dietary instructions should I follow?

Special Dietary Instructions for Xyrem:

• Empty Stomach: Xyrem should be taken on an empty stomach, at least 2 hours after eating. This is to ensure proper absorption and efficacy of the medication.
• Avoid High-Fat Meals: High-fat meals may delay the absorption of Xyrem. It is advisable to avoid such meals around the time of Xyrem administration.

What should I do if I forget a dose?

If you forget to take a dose of Xyrem:

• Missed Bedtime Dose: If you forget the bedtime dose, skip that dose and take the next scheduled dose at the regular time. Do not double the dose to make up for the missed one.
• Missed Second Dose: If you miss the second dose, do not take it later in the night or the next day. Resume your regular dosing schedule the following night.
• Contact Your Healthcare Provider: If you are unsure about what to do or if you have missed multiple doses, contact your healthcare provider for guidance.

What side effects can this medication cause?

Xyrem (sodium oxybate) can cause various side effects, and it’s important to be aware of them. Keep in mind that not everyone will experience these side effects, and their severity can vary from person to person. If you are prescribed Xyrem, your healthcare provider will monitor your response to the medication. If you notice any unusual or severe side effects, it’s crucial to contact your healthcare provider promptly. Some common and serious side effects of Xyrem include:

Common Side Effects:

• Sodium Retention: Xyrem contains sodium, and in some cases, it may lead to sodium retention. This can be a concern for individuals with conditions like hypertension or heart failure.
• Nausea and Vomiting: Some people may experience nausea and vomiting, especially when starting Xyrem. Taking the medication on an empty stomach and avoiding high-fat meals may help reduce this side effect.
• Dizziness: Xyrem can cause dizziness, especially when getting up from a sitting or lying position. It’s important to stand up slowly to minimize the risk of falls.
• Enuresis (Bedwetting): Bedwetting has been reported as a side effect of Xyrem use.

Serious Side Effects:

• Respiratory Depression: Xyrem is a central nervous system depressant and can cause respiratory depression, which is a serious side effect. This risk is higher when Xyrem is used in combination with alcohol or other central nervous system depressants.
• Central Nervous System Effects: Xyrem can cause central nervous system effects, including seizures, especially in individuals with a history of seizures.
• Depression and Suicidal Ideation: Some individuals using Xyrem have reported depression and suicidal thoughts. Monitoring for changes in mood is important.
• Hypersensitivity Reactions: Allergic reactions, including rash, hives, and swelling, have been reported in some individuals using Xyrem.
• Sleepwalking and Sleep-Related Activities: Xyrem has been associated with an increased risk of sleepwalking and other complex sleep-related behaviors. These behaviors may occur without any memory of the event.

It’s essential to report any side effects or concerns to your healthcare provider promptly. Additionally, follow all recommended precautions and instructions, including avoiding alcohol and other medications that can depress the central nervous system while taking Xyrem. Keep regular appointments with your healthcare provider to monitor your response to the medication and make any necessary adjustments to your treatment plan.

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

Storage and Disposal of Xyrem:

• Storage: Keep Xyrem in a safe and secure place, out of reach of children and pets. Store it at room temperature away from light and moisture. Do not freeze the medication.
• Secure Location: Due to the potential for abuse, Xyrem is only available through a restricted distribution program. It’s important to keep it in a secure location and follow the guidelines of the Xyrem Success Program.
• Disposal: If you have unused or expired Xyrem, follow the specific disposal instructions provided by your healthcare provider or pharmacist. Do not dispose of medications in wastewater or household trash unless instructed to do so.

In case of emergency/overdose

If you suspect an overdose or experience severe side effects, seek emergency medical attention immediately. Symptoms of overdose may include:

• Severe drowsiness
• Difficulty breathing
• Loss of consciousness
• Seizures

It’s important to have a plan in case of an emergency. Keep a list of emergency contacts, including your healthcare provider and local poison control center, readily available.

What other information should I know

• Follow Doctor’s Instructions: Take Xyrem exactly as prescribed by your healthcare provider. Do not adjust the dosage without consulting your doctor.
• Avoid Alcohol: It’s crucial to avoid alcohol while taking Xyrem. Combining Xyrem with alcohol can lead to dangerous respiratory depression and other serious side effects.
• Regular Monitoring: Your healthcare provider will likely monitor your response to Xyrem regularly. Keep all scheduled appointments and report any concerns or changes in your health.
• Inform Healthcare Providers: Inform all healthcare providers, including dentists and emergency room personnel, that you are taking Xyrem. This information is important for your overall medical care.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits of Xyrem with your healthcare provider.
• Central Nervous System Effects: Be cautious when engaging in activities that require mental alertness, such as driving or operating machinery, as Xyrem can cause dizziness and sedation.

Always keep an open line of communication with your healthcare provider. If you have any questions, concerns, or experience side effects, contact your healthcare provider promptly. Adherence to prescribed doses and recommended guidelines is essential for the safe and effective use of Xyrem.