If you or someone in your family has narcolepsy, you know how much the condition can affect everyday life.
People with narcolepsy may have disrupted sleep at night and extreme sleepiness during the day. They may fall asleep suddenly, sometimes during an activity or even mid-conversation. These symptoms can interfere with work, school, and other daily activities.
Some people with narcolepsy also have cataplexy, which is a sudden, brief episode of muscle weakness. For example, their head may drop or their knees may buckle. Cataplexy is often triggered by strong emotions, such as laughter, excitement, or surprise.
Lumryz (sodium oxybate) is a once-nightly medicine for the treatment of excessive daytime sleepiness (EDS) or cataplexy in people with narcolepsy.
Below are common questions and answers about Lumryz, including how it works for narcolepsy, how to take it, and what benefits were seen in studies. You may also want to read about possible Lumryz side effects and interactions, including what to expect and how to manage them.
How Does Lumryz Work for Narcolepsy?
The exact way Lumryz works is not fully understood. Lumryz contains sodium oxybate, also called gamma-hydroxybutyrate (GHB), which affects the chemicals in the brain that help regulate sleep and wakefulness.
People with narcolepsy often have poor-quality sleep at night and feel very sleepy during the day. Lumryz may help you have a deeper, more restful sleep at night. Better nighttime sleep may help reduce excessive daytime sleepiness the next day.
Lumryz also helps reduce episodes of cataplexy, which are sudden, brief losses of muscle control that can happen during strong emotions such as laughter or excitement. These benefits may be related to how sodium oxybate affects certain brain cells involved in sleep and wakefulness, but the exact way it works is not known.
Unlike other sodium oxybate products that are taken twice each night, Lumryz is an extended-release medicine that is taken once at bedtime. It releases the medicine gradually throughout the night.
How Do I Take Lumryz?
Lumryz is a powder that you mix with water and take by mouth once each night while you are in bed. The pharmacy will provide dose packets, a mixing cup, and instructions for preparing the medicine safely.
Here are some important things to know when taking Lumryz:
- Take it once each night. Lumryz is taken by mouth as a single dose at bedtime. It is designed to work throughout the night, so you do not need to wake up to take a second dose.
- Wait to take your dose at least two hours after eating. Food can affect how well Lumryz is absorbed, so take it at least two hours after eating.
- Mix it with water before taking it. Before going to bed, the dose should be prepared on a flat surface at the bedside. Fill the provided mixing cup with about one-third cup (about 80 milliliters) of water. Empty the entire dose packet into the mixing cup with water, put the cap on, then shake well for at least a minute. Do not use hot water. You may add a zero-calorie drink mix or flavored water enhancer if desired. Drink the mixture within 30 minutes after mixing.
- Take it only after you are in bed. Lumryz can cause you to fall asleep very quickly, often within 5-15 minutes. Take your dose while you are already in bed, then lie down right away and stay in bed.
- Avoid alcohol and certain medicines with Lumryz. Do not drink alcohol or take sleep aids while using Lumryz. Many other medicines that cause drowsiness can also increase the risk of serious side effects when taken with Lumryz. Tell your pharmacist and other health care providers about all medicines you take before starting Lumryz.
- Do not drive or do other hazardous activities for at least six hours after taking it. Even after six hours have passed, wait until you know how Lumryz affects you before driving, operating machinery, or doing anything that requires you to be fully alert.
- If you miss a dose, skip it. If you do not take your dose at bedtime, skip it and take your next dose the following night. Do not take Lumryz later during the night. Also, never take two doses in one night.
- Store it safely. Lumryz is a Schedule III controlled substance and is available only through a restricted program because of its risk for misuse and serious side effects. Keep it in a safe place out of the reach of children and pets.
Your health care provider will tell you exactly how much Lumryz to take. Here are the typical recommended dosages of Lumryz:
- For adults, the usual starting dose is 4.5 grams once each night. Your health care provider may raise the dose by 1.5 grams each week based on how well it works and how well it is tolerated. The recommended dose range for adults is 6-9 grams once each night.
- For children, the starting dose and maximum dose vary depending on body weight. For example, children aged 7 or older who weigh about 99 pounds or more (45 kilograms) may start with 4.5 grams once each night. The dose may be adjusted based on how well it works and how well it is tolerated. Ask your prescriber if you have questions about your child’s dosage.
Always check with your health care provider before making any dose changes.
How Was Lumryz Studied For Narcolepsy?
Lumryz was studied in a clinical trial of 212 people with narcolepsy. Here are some details about the study participants:
- About three-quarters (76%) had narcolepsy type 1, which includes excessive daytime sleepiness and cataplexy, while the other 24% had narcolepsy type 2 (excessive daytime sleepiness without cataplexy).
- Their ages ranged from 16 to 72 years, with the average age being 31 years.
- About 68% were female, and the rest were male.
- Most participants (about 76%) were White, 17% were Black/African American, 5% were Asian, and 2% identified as multiracial or other races.
- About 63% continued taking stable doses of stimulant medicines during the study. (Stimulant medicines are commonly used to help people with narcolepsy stay awake during the day. Examples include amphetamines, methylphenidate, and modafinil.)
People in the study were randomly assigned to take Lumryz or a placebo (a fake treatment with no active medicine). Neither they nor the researchers knew who was receiving which treatment. Treatment lasted a total of 13 weeks. People started with a 4.5-gram nightly dose of Lumryz, which was gradually increased over eight weeks to a maximum nightly dose of 9 grams, followed by five weeks at a stable dose.
The study measured three main outcomes:
- Ability to stay awake during the day using the Maintenance of Wakefulness Test (MWT). This test measures how long a person can stay awake in a quiet room during several daytime sessions. Longer times mean better ability to stay awake.
- Overall improvement in narcolepsy symptoms using a rating scale to compare a person's symptoms before and after treatment.
- Number of cataplexy attacks per week in people with narcolepsy type 1.
Before the study treatment began, people in both groups could stay awake for only about five minutes on average during the MWT. Among participants with narcolepsy type 1, the average number of cataplexy attacks before treatment was about 19 per week.
Results after 13 weeks of treatment
The clinical trial showed that Lumryz improved all three main study outcomes compared with placebo.
- Better ability to stay awake. At the recommended doses (6-9 grams), people taking Lumryz stayed awake about five to six minutes longer during daytime testing than those taking placebo.
- Improvement in overall narcolepsy symptoms. By the end of the study, 73% of people taking 9 grams of Lumryz were rated as "much improved" or "very much improved," compared with 32% of people taking placebo.
- Fewer cataplexy attacks. People with narcolepsy type 1 who took Lumryz had about seven fewer cataplexy attacks each week than those taking placebo.
Overall, the study showed that Lumryz reduced excessive daytime sleepiness, lowered the number of cataplexy attacks, and improved overall narcolepsy symptoms. Your results may differ from what was seen in clinical studies.
How Was Lumryz Studied in Children With Narcolepsy?
Lumryz is approved for treating cataplexy or excessive daytime sleepiness in children aged 7 years or older with narcolepsy. While the medicine has not been studied directly in children, its approval for this age group is based on a study of an immediate-release medicine that contains the same active ingredient (sodium oxybate). Lumryz is an extended-release medicine.
The study included 106 children and adolescents aged 7-17 years with narcolepsy. About half continued taking stable doses of stimulant medicines during the study. Some participants were already taking sodium oxybate, while others started treatment during the trial. After reaching a stable dose, 63 children were randomly assigned to either continue sodium oxybate or switch to placebo without knowing which treatment they received.
The results showed that children who continued sodium oxybate had fewer weekly cataplexy attacks, less daytime sleepiness, and improved overall ratings of narcolepsy symptoms. In contrast, children who switched to placebo had worsening daytime sleepiness and more frequent cataplexy attacks.
These findings support the use of Lumryz in children aged 7 years or older with narcolepsy. While results vary from person to person, talk to your child's health care provider about whether Lumryz may be right for your child.
How Much Does Lumryz Cost?
The amount you pay for Lumryz depends on your insurance coverage and whether you qualify for financial assistance. Because Lumryz is a specialty medicine, some insurance plans require approval before they will cover it.
Ask your health care provider or pharmacist about available support programs. Eligible patients may pay as little as $0 for their prescription. Visit this website from the drugmaker or call them at 844-485-7636 to learn more about financial support options and other resources.
