Patient information: uses, side effects, how to take - Lumryz

What is the most important information I should know about LUMRYZ?

LUMRYZ is a central nervous system (CNS) depressant. Taking LUMRYZ with other CNS depressants such as medicines used to make you 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)

○ death

Ask your doctor if you are not sure if you are taking a medicine listed above.

LUMRYZ is a federal controlled substance (CIII). The active ingredient of LUMRYZ is a form of gamma-hydroxybutyrate (GHB) that is also a federal controlled substance (CI). Abuse of illegal GHB, either alone or with other CNS depressants may cause serious medical problems, including:

○ seizure

○ trouble breathing (respiratory depression)

○ changes in alertness (drowsiness)

○ coma

○ death

Call your doctor right away if you have any of these serious side effects.

Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.
Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Because of the risk of CNS depression, abuse, and misuse, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. For more information on how to receive LUMRYZ, visit www.LUMRYZREMS.com. Before you receive LUMRYZ, your doctor or pharmacist will make sure that you understand how to use LUMRYZ safely and effectively. If you have any questions about LUMRYZ, ask your doctor or call the LUMRYZ REMS at 1-877-453-1029.

What is LUMRYZ?

LUMRYZ is a prescription medicine used in people 7 years of age or older to treat the following symptoms of narcolepsy:

sudden onset of weak or paralyzed muscles (cataplexy), or
excessive daytime sleepiness (EDS)

It is not known if LUMRYZ is safe and effective in children under 7 years of age.

Do not take LUMRYZ if you or your child:

take other sleep medicines or sedatives (medicines that cause sleepiness)
drink alcohol
have a rare problem called succinic semialdehyde dehydrogenase deficiency

Before taking LUMRYZ, tell your doctor about all medical conditions, including if you or your child:

have a history of drug abuse.
have short periods of not breathing while sleeping (sleep apnea).
have trouble breathing or have lung problems. You or your child may have a higher chance of having serious breathing problems when taking LUMRYZ.
have or had depression or have tried to harm yourself. You or your child should be watched carefully for new symptoms of depression.
have or had behavior or other psychiatric problems such as:

○ anxiety

○ seeing or hearing things that are not real (hallucinations)

○ feeling more suspicious (paranoia)

○ being out of touch with reality (psychosis)

○ acting aggressive

○ agitation

have liver problems.
are on a salt-restricted diet. LUMRYZ contains a lot of sodium (salt) and may not be right for you or your child.
have high blood pressure.
have heart failure.
have kidney problems.
are pregnant or plan to become pregnant. It is not known if LUMRYZ can harm your unborn baby.
are breastfeeding or plan to breastfeed. LUMRYZ passes into breast milk. You and your doctor should decide if you or your child will take LUMRYZ or breastfeed.

Tell your doctor about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially, tell your doctor if you or your child take other medicines to help you or your child sleep (sedatives) or that may make you or your child sleepy, such as some medicines to treat pain, anxiety, depression, or seizures. Know the medicines you or your child takes. Keep a list of them to show your doctor and pharmacist when you or your child get a new medicine.

How should I take or give LUMRYZ?

Read the Instructions for Use for detailed instructions on how to take or give LUMRYZ.
Take or give LUMRYZ exactly as your doctor tells you to take or give it.
LUMRYZ is taken by mouth 1 time at bedtime.
Wait at least 2 hours after eating before taking or giving LUMRYZ.
After mixing LUMRYZ, take or give it within 30 minutes. Do not mix LUMRYZ with hot water.
Take or give LUMRYZ at bedtime while you or your child is in bed and lie down immediately. You or your child should remain in bed after taking LUMRYZ.
LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed.
Never change the LUMRYZ dose without talking to your or your child's doctor.
LUMRYZ can cause sleep very quickly without feeling drowsy. Some people fall asleep within 5 minutes and most fall asleep within 15 minutes. The time it takes to fall asleep might be different from night to night.
Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
If you or your child take too much LUMRYZ, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of LUMRYZ?

LUMRYZ can cause serious side effects, including:

See “What is the most important information I should know about LUMRYZ?”
breathing problems, including:

○ slower breathing.

○ trouble breathing.

○ short periods of not breathing while sleeping (sleep apnea).

People who already have breathing or lung problems have a higher chance of having breathing problems when they use LUMRYZ.

mental health problems, including:

○ confusion

○ seeing or hearing things that are not real (hallucinations)

○ unusual or disturbing thoughts (abnormal thinking)

○ feeling anxious or upset

○ depression

○ thoughts of killing yourself or trying to kill yourself

○ increased tiredness

○ feelings of guilt or worthlessness

○ difficulty concentrating

Call your doctor right away if you or your child has symptoms of mental health problems, or a change in weight or appetite.

sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start or your child starts sleepwalking. Your doctor should check you or your child.

The most common side effects of LUMRYZ in adults include:

nausea
dizziness
bedwetting
headache
vomiting

The most common side effects of LUMRYZ in children 7 years of age and older include:

nausea ● decreased weight
bedwetting ● decreased appetite
vomiting ● dizziness
headache ● sleepwalking

Side effects may increase when taking higher doses of LUMRYZ.

These are not all the possible side effects of LUMRYZ. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LUMRYZ?

Store LUMRYZ at room temperature between 68°F to 77°F (20°C to 25°C).
Store LUMRYZ in the original packet prior to mixing with water.
LUMRYZ suspension should be taken within 30 minutes of preparation.
When you have finished using the LUMRYZ packet, throw it away (dispose of it) in the trash. If any LUMRYZ remains in the packet, rinse it down the sink before throwing away.

Keep LUMRYZ and all medicines out of the reach of children and pets.

General information about the safe and effective use of LUMRYZ.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LUMRYZ for a condition for which it was not prescribed. Do not give LUMRYZ to other people, even if they have the same symptoms. It may harm them.

You can ask your pharmacist or doctor for information about LUMRYZ that is written for health professionals.

What are the ingredients in LUMRYZ?

Active ingredients: sodium oxybate

Inactive ingredients: carrageenan, hydrogenated vegetable oil, hydroxyethyl cellulose, magnesium stearate, malic acid, methacrylic acid copolymer, microcrystalline cellulose, povidone, xanthan gum.

Manufactured For:

Alkermes, Inc. Waltham, MA 02451

For more information, go to www.LUMRYZREMS.com or call the LUMRYZ REMS at 1-877-453-1029.

INSTRUCTIONS FOR USE

This Instructions for Use contains information on how to take LUMRYZ. Read this Instructions for Use before you (or your child) take LUMRYZ and each time you (or your child) get a refill. There may be new information.

This information does not take the place of talking to your doctor about your (or your child's) medical condition or your (or your child's) treatment. If you have questions, please talk with your doctor.

Take (or give) 1 packet of LUMRYZ each day at bedtime.
You will need to mix LUMRYZ with water before you take or give your child the dose.
You (or your child) should avoid getting out of bed after taking LUMRYZ. Some people fall asleep within 5 minutes of taking LUMRYZ and most will fall asleep within 15 minutes. The time it takes to fall asleep might be different from night to night.
Medicines that cause sleepiness should not be used while taking LUMRYZ.
Do not use LUMRYZ with alcohol.
Do not drive or operate heavy machinery within 6 hours of taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.
Mix and take (or give) LUMRYZ within 30 minutes. If not taken or given within 30 minutes of mixing, throw it away (dispose of it) and prepare a new dose.

LUMRYZ comes in different package sizes. The LUMRYZ package you receive may look different from the picture shown above.

Additional supplies needed

Store LUMRYZ at room temperature, between 68°F to 77°F (20°C to 25°C).
Store LUMRYZ in the original packet prior to mixing with water.
LUMRYZ suspension should be taken within 30 minutes of preparation.
When you have finished using the LUMRYZ packet, throw it away (dispose of it) in the trash. If any LUMRYZ remains in the packet, rinse it down the sink before throwing away.
Store LUMRYZ and all medicines out of the reach of children and pets.

Before using a new LUMRYZ carton, check the tamper-evident seal on the carton lid to make sure it is not missing or broken.
Do not use if the tamper-evident seal is missing or broken.
Check the expiration date (EXP) on the LUMRYZ carton.
Do not use LUMRYZ after the expiration date (EXP) on the label has passed.
Open the LUMRYZ carton by tearing the tamper-evident seal with your hands or by using a pair of scissors.

Clean the mixing cup by rinsing it with water and letting it dry before each use.
Do not use a measuring device other than the mixing cup that comes in your LUMRYZ carton to measure and take a dose of LUMRYZ.
Check the expiration date (EXP) on the packet label. Do not use the LUMRYZ packet after the expiration date (EXP) has passed.

Important: Make sure to prepare LUMRYZ at bedside.

1.) At your (or your child's) bedside, open the mixing cup by twisting the cap to the left (counter-clockwise) to remove it.

2.) Fill the mixing cup with water up to Fill Line A (top line) and set the mixing cup down on a flat surface.

3.) Open 1 packet:

Use scissors to cut open the packet along the Cutting Line, located on the back of the packet.

Fold the packet in half at the gray Tear Mark located on the back of the packet.

Tear the packet open with your hands.

4.) Pour the entire content from the packet into the water-filled mixing cup.

Make sure there is no powder left in the packet.

5.) Close the mixing cup by twisting the cap to the right (clockwise) until firmly closed.

6.) Mix the water and powder solution by shaking the closed mixing cup well for at least 60 seconds (1 minute).

7.) Make sure the solution is mixed thoroughly.

The mixed solution will appear slightly milky with some lumps.

The mixing cup cap is not child resistant. If the mixed solution is not drank immediately, then do not remove the cap, and keep out of reach of children.

8.) Open the mixing cup by twisting the cap to the left (counter-clockwise) and remove it.

9.) While sitting in bed drink (or have your child drink) the mixed solution within 30 minutes of mixing.

Make sure you (or your child) drink all the mixed solution in the mixing cup.

10.) Immediately refill the mixing cup with water up to Fill Line B (lower line) to mix in any medicine left in the mixing cup.

Do not open another packet of LUMRYZ. Take (or give) only 1 packet each day at bedtime.

11.) Close the mixing cup by twisting the cap to the right (clockwise) until firmly closed.

12.) Shake well again for 10 seconds.

13.) Open the mixing cup by twisting the cap to the left (counter-clockwise) and remove it.

14.) Drink (or have your child drink) the mixed solution immediately after mixing.

Make sure you (or your child) drink all the mixed solution in the mixing cup.

15.) Leave the empty mixing cup at your (or your child's) bedside and immediately lie down (or have your child lie down) to go to sleep.

Avoid getting out of your bed (or having your child get out of bed) after taking LUMRYZ.

16.) The next day, place the empty LUMRYZ packet in the trash.

If any LUMRYZ remains in the packet, rinse it down the sink before (prior to) throwing away (disposal).

17.) Empty any unused LUMRYZ down the sink drain the next day.

Clean the mixing cup by rinsing it with water and letting it dry before each use.

After you (or your child) finish all of the packets in the LUMRYZ carton

After you have (or your child has) finished your (or your child's) last packet in the carton, throw away the rinsed mixing cup in the trash.

If you have additional questions about LUMRYZ, talk with your doctor.

You can also contact:

Alkermes, Inc

Waltham, MA 02451

For more information on LUMRYZ, visit www.lumryz.com or call 888-828-2335.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 08/2026

LUM-IFU:R4

Lumryz (Sodium oxybate): Uses, Side Effects and Dosage