Sodium Oxybate Extended-Release Suspension

What is this medication?

SODIUM OXYBATE (SOE dee um OX i bate) treats narcolepsy. It works by decreasing daytime sleepiness, which can help you sleep better at night. It also reduces the number of episodes of sudden muscle weakness (cataplexy).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): LUMRYZ

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Depression
• Diet low in salt
• Frequently drink alcohol
• Heart disease
• High blood pressure
• History of substance use disorder
• Kidney disease
• Liver disease
• Lung or breathing disease, such as asthma or COPD
• Mental health conditions
• Sleep apnea
• Succinic semialdehyde dehydrogenase deficiency
• Suicidal thoughts, plans, or attempt
• An unusual or allergic reaction to oxybate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it once daily at bedtime, while you are in bed. Lie down right away after taking the dose and remain in bed. Take it on an empty stomach, at least 2 hours after food. Keep taking it unless your care team tells you to stop.

Mix the contents of the medication packet with water in the provided cup. Shake for at least 60 seconds. Drink the solution within 30 minutes of mixing. Refill the cup with water to mix any medication left in the cup. Mix again for 10 seconds and drink the solution.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Alcohol
• Medications that help you fall asleep

This medication may also interact with the following:

• Benzodiazepines, such as alprazolam, diazepam, or lorazepam
• Certain antihistamines
• Certain medications for depression, such as amitriptyline, fluoxetine, sertraline, or trazodone
• Certain medications for seizures, such as divalproex sodium, phenobarbital, primidone, valproic acid
• Medications that cause drowsiness before a procedure, such as propofol
• Medications that relax muscles
• Opioids for pain or cough
• Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. This medication has a risk of abuse and dependence. Your care team will check you for this while you take this medication.

This medication may affect your coordination, reaction time, or judgment. Do not engage in activities that require mental alertness, such as driving or operating machinery, for at least 6 hours after taking this medication. You may fall asleep quickly after taking this medication. Remain in bed and do not attempt to sit or stand up. Drinking alcohol with this medication can increase the risk of these side effects.

You may do unusual sleep behaviors or activities you do not remember the day after taking this medication. Activities include driving, making or eating food, talking on the phone, sexual activity, or sleep walking. Stop taking this medication and call your care team right away if you find out you have done activities like this.

This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Sleep apnea—loud snoring, gasping or choking during sleep, daytime sleepiness
• Sleepwalking

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Bedwetting
• Dizziness
• Headache
• Loss of appetite
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). After mixing the powder with water, it should be taken within 30 minutes. Get rid of any unused medication after the expiration date.

This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, flush it down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.