Pronunciation: LOOM rize
Generic name: sodium oxybate
Dosage form: granules for extended-release oral suspension (4.5 g, 6 g, 7.5 g, 9 g.)
Drug class: Miscellaneous anxiolytics, sedatives and hypnotics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 30, 2024.

What is Lumryz? 

Lumryz (sodium oxybate) is a prescription medicine used to treat cataplexy and excessive daytime sleepiness (EDS) caused by narcolepsy, in patients that are 7 years and older. Lumryz helps to improve the quality and quantity of deep sleep at night, which may reduce excessive daytime sleepiness and the number of sleeping periods during the day and improve cataplexy. Lumryz is a central nervous system depressant.

Lumryz mechanism of action (MOA) is thought to be activating the GABA-B receptor, which may improve sleep by increasing the time spent in the sleep stages (N2 and N3) and decreasing the shift to stages N1/Wake/REM, which results in deeper sleep. The active ingredient is sodium oxybate, the sodium salt of gamma-hydroxybutyrate (GHB), a known street drug of abuse.

What is Lumryz used to treat?

Lumryz FDA approval was received on May 01, 2023, it is now indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Narcolepsy is a chronic neurological disorder that affects the brain's ability to control sleep-wake cycles.

Excessive daytime sleepiness is characterized by persistent sleepiness where an overwhelming sense of sleepiness comes on quickly. Cataplexy is characterized by a sudden onset of weak or paralyzed muscles.

Is Lumryz a controlled substance?

Yes, Lumryz is a Schedule III controlled substance (CIII) , which means it has a potential for abuse less than substances in Schedules 1 and 2, and it has an accepted medical use in treatment in the United States. Abuse of Lumryz may lead to moderate or low physical dependence or high psychological dependence.

Lumryz REMS program

Lumryz is only available through the Lumryz ​​REMS (Evaluation and Mitigation Strategy) program due to the potential for abuse and the risk of the serious side effects of significant CNS and respiratory depression. The REMS program goal is to reduce the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion. 

The patient receiving the prescription must read all relevant material, receive counseling from the prescriber, fill out the Lumryz Patient Enrollment Form, and fill out the Patient Counseling Checklist with the pharmacist. You must be registered in the program and understand the risks and benefits of this medicine. The Lumryz REMS programs require the prescriber and dispensing pharmacists to be certified and follow all guidelines. 

If you have any questions, ask your doctor or call the Lumryz REMS at 1-877-453-1029.

Lumryz side effects

Common Lumryz side effects

The most common Lumryz side effects include nausea, dizziness, bedwetting, headache, and vomiting. Side effects may increase when taking higher doses, these side effects occurred in 5% or more of adult patients.

The most common Lumryz side effects in children for immediate-release sodium oxybate were nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking. These side effects occurred in 5% or more of patients.

 Serious Lumryz side effects 

Lumryz can cause serious side effects, including:

• 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 this medicine.
• 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 have symptoms of mental health problems or a change in weight or appetite.
• sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start sleepwalking. Your doctor should check you.

Also, see the warning section.

These are not all the possible side effects. 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-FDA1088.

Related/similar drugs

Warnings

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 this medicine 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 a dose. Those activities should not be done until you know how the medicine affects you.

Keep this medicine in a safe place to prevent abuse and misuse. Selling or giving away this medicine 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.

Who should not take Lumryz?

You should not take this medicine if you:

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

What should I tell my doctor before taking Lumryz?

Before you start treatment, tell your doctor about all medical conditions, including if you:

• have a history of drug abuse.
• have short periods of not breathing while sleeping (sleep apnea).
• have trouble breathing or have lung problems. You may have a higher chance of having serious breathing problems when taking Lumryz.
• have or had depression or have tried to harm yourself. You 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.
• have high blood pressure.
• have heart failure.
• have kidney problems.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine can harm your unborn baby.

Breastfeeding

Tell your doctor if you are breastfeeding or plan to breastfeed. Lumryz passes into breast milk. You and your doctor should decide if you will take Lumryz or breastfeed.

How should I take Lumryz?

• Read the Instructions for Use at the end of this page for detailed instructions on how to prepare and take a dose.
• Take this medicine exactly as your doctor tells you to take it.
• Lumryz is taken by mouth 1 time at bedtime.
• Wait at least 2 hours after eating before taking a dose.
• After mixing Lumryz, take it within 30 minutes. Do not mix with hot water.
• Take Lumryz at bedtime while you are in bed and lie down immediately. You should remain in bed after taking a dose.
• Lumryz can cause physical dependence and craving for the medicine when it is not taken as directed.
• Never change the dose without talking to your 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 take too much or overdose, call your doctor or go to the nearest hospital emergency room right away.

Dosing information

Lumryz  Dose for Adults Narcolepsy

Initiate dosage at 4.5 g once per night orally. Titrate to effect in increments of 1.5 g per night at weekly intervals.
Recommended dosage range: 6 g to 9 g once per night orally.

Use:
- treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

Lumryz Dose Pediatric Patients (7 Years of Age and Older)

The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight 

Pediatric patients weighing 45 kg or greater (7 Years and older)

Initiate dosage at 4.5 g once per night orally. Increase dose, depending on effect, in increments of 1.5 g per night at weekly intervals to the maximum recommended dosage of 9 g once per night orally. The dosage may be gradually titrated based on efficacy and tolerability

Pediatric patients weighing less than 45 kg (7 Years and older)

Because the recommended starting dosage cannot be achieved with the available strengths of Lumryz use another sodium oxybate product to initiate treatment.

Important General Administration Information

• Prepare the dose prior to bedtime
• Suspend dose in approximately ⅓ cup of water in the mixing cup provided
• Allow 2 hours after eating before dosingTake LUMRYZ while in bed and lie down after dosing.
• See the Instructions for Use at the end of this page for detailed instructions on how to prepare and take a dose.

Lumryz is available in packets of 4.5 g, 6 g, 7.5 g, or 9 g.

What other drugs will affect Lumryz?

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

Especially, tell your doctor if you take other medicines to help you sleep (sedatives) or that may make you sleepy, such as some medicines to treat pain, anxiety, depression, or seizures.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Storage

• Store in the original packet before mixing with water. After mixing with water, store Lumryz in the mixing cup provided in each kit.
• Store at room temperature between 68°F to 77°F (20°C to 25°C).
• The suspension should be taken within 30 minutes of preparation.
• When you have finished using the packet, throw it away (dispose of it) in the trash.
• Lumryz comes in a child-resistant package.

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

Lumryz Prescribing Information

Review the Lumryz Prescribing Information for more detailed information about this medicine. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

Prescribing Information (PI) Package Insert is sometimes called  Lumryz Package Insert  or FDA label.

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.

Instructions for Use

Important information

• Take 1 packet of Lumryz each day at bedtime.
• Avoid getting out of your bed after taking a dose. Some people fall asleep within 5 minutes of taking a dose, and most will fall asleep within 15 minutes. The time it takes you 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 a dose.
• Mix and take Lumryz within 30 minutes. If not taken within 30 minutes of mixing, throw it away (dispose of it) and prepare a new dose.

Before using Lumryz

• Before starting a new 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 carton.
• Do not use after the expiration date (EXP) on the label has passed.
• Open the carton by tearing the tamper-evident seal with your hands or by using a pair of scissors.

Before each Use

• 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 the carton to measure and take a dose.
• Check the expiration date (EXP) on the packet label. Do not use the packet after the expiration date (EXP) has passed.

Gather the following supplies and place them on a flat surface at your bedside:

• 1 bottle or glass of water (1/3 cup). Do not use hot water.
• 1 Lumryz packet
• 1 clean mixing cup. The cap is not child resistant.
• 1 pair of scissors (optional)

Mix the Lumryz solution at your bedside

1. At your 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
   or
   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 taken immediately, then do not remove the cap, and keep out of reach of children.

Take the Lumryz solution at your bedside

1. Open the mixing cup by twisting the cap to the left (counter-clockwise) and remove it.
2. While sitting in bed drink the mixed solution within 30 minutes of mixing. 
   Make sure to drink all the mixed solution in the mixing cup.
3. Immediately refill your 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. Take only 1 packet each day at bedtime.
4. Close the mixing cup by twisting the cap to the right (clockwise) until firmly closed.
5. Shake well again for 10 seconds.
6. Open the mixing cup by twisting the cap to the left (counter-clockwise) and remove it.
7. Drink the mixed solution immediately after mixing. 
   Make sure to drink all the mixed solution in the mixing cup.
8. Leave the empty mixing cup at your bedside and immediately lie down to go to sleep. 
   Avoid getting out of your bed after taking your dose.

How do I throw away (dispose of) Lumryz?

1. The next day, place the empty packet in the trash.
   If any Lumryz remains in the packet, rinse it down the sink prior to disposal.
2. 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 finish all of the packets in your Lumryz carton

After you have finished your last packet in the carton, throw away the rinsed mixing cup in the trash.

Company 

Distributed By: Avadel CNS Pharmaceuticals, LLC Chesterfield, MO 63005

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