Lumryz

Generic name: Sodium Oxybate
Dosage form: granules for extended-release oral suspension
Drug class: Miscellaneous anxiolytics , Antineoplastic Agents

Usage of Lumryz

Lumryz is a prescription medicine used to treat cataplexy and excessive daytime sleepiness (EDS) in adults with narcolepsy.

Lumryz contains the central nervous system depressant drug sodium oxybate, which is the sodium salt of gamma hydroxybutyrate (GHB).

Sodium oxybate is a Schedule III controlled substance.

Sodium oxybate is thought to work in the treatment of narcolepsy by increasing the amount of time the body spends in a deep sleep while resting, resulting in decreased sleepiness while not resting.

It is not known if this medicine is safe and effective in children.

Lumryz side effects

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.

Before taking 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

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How to use Lumryz

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

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 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.

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.

Disclaimer

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