Lumryz is used to treat cataplexy or excessive daytime sleepiness (EDS) in adults 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.

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

Keep Lumryz 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. You must be enrolled in the Lumryz REMS to receive Lumryz. For more information, visit www.LumryzREMS.com. Before you receive your prescription, your doctor or pharmacist will make sure that you understand how to use Lumryz safely and effectively. If you have any questions, ask your doctor or call the Lumryz REMS at 1-877-453-1029.

• 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.

Usual Adult Dose for 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

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.

Lumryz can cause serious side effects, including:

• See Important information.
• 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 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.

The most common side effects include:

• nausea
• dizziness
• bedwetting
• headache
• vomiting

Side effects may increase when taking higher doses.

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.

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.