Description

LUMRYZ® (sodium oxybate) 7.5 g for Extended-Release Oral Suspension

lumryz

What Is LUMRYZ?

LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription central nervous system (CNS) depressant approved for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy . It is the sodium salt of gamma-hydroxybutyrate (GHB) and is classified as a Schedule III controlled substance under the Controlled Substances Act .

What this means: LUMRYZ is a once-nightly medication that helps manage two of the most disruptive symptoms of narcolepsy: sudden muscle weakness (cataplexy) and overwhelming daytime sleepiness. It is not a cure for narcolepsy but a treatment to help manage symptoms.

Who Is LUMRYZ For?

LUMRYZ is indicated for patients aged 7 years and older with narcolepsy who experience either:

• Cataplexy: Sudden, brief loss of muscle control triggered by strong emotions

• Excessive Daytime Sleepiness (EDS): Persistent, overwhelming sleepiness during waking hours 

Who It Is NOT Intended For:

• Patients under 7 years of age (safety and efficacy not established)

• Patients with succinic semialdehyde dehydrogenase deficiency

• Patients taking sedative hypnotics or alcohol

• Patients with hepatic impairment for initiation of therapy 

Verification from the manufacturer or official documentation is recommended before determining suitability for any individual patient.

What Does LUMRYZ Do?

LUMRYZ works as a CNS depressant that helps consolidate nighttime sleep and reduce symptoms of narcolepsy. The precise mechanism by which sodium oxybate produces its effects is not fully understood, but it is thought to promote slow (delta) wave sleep and improve sleep architecture .

In clinical trials, LUMRYZ demonstrated:

What This Means: Clinical data suggest LUMRYZ can meaningfully improve both daytime functioning and nighttime sleep quality for people with narcolepsy. However, individual responses vary, and results seen in clinical trials may not predict individual outcomes.

What Makes LUMRYZ Different From Other Sodium Oxybate Products?

LUMRYZ is the first and only once-nightly extended-release sodium oxybate formulation approved in the United States .

What This Means: The once-nightly design may reduce the burden and sleep disruption associated with twice-nightly dosing. In an open-label study, most patients who switched from twice-nightly to once-nightly sodium oxybate preferred the once-nightly formulation .

Key Specifications

Product Specifications Table

Administration Instructions for 7.5g Dose:

• Prepare dose before bedtime in the provided mixing cup

• Suspend in approximately ⅓ cup (80 mL) of water 

• May use calorie-free drink mix or flavored water enhancer 

• Allow at least 2 hours after eating before dosing 

• Take while in bed and lie down immediately after dosing

• Consume within 30 minutes of mixing

• Take at the same time each night as prescribed

Important Safety Considerations

Boxed Warning: CNS Depression and Abuse/Misuse

LUMRYZ carries a Boxed Warning for CNS depression and abuse/misuse :

• LUMRYZ is a CNS depressant; respiratory depression can occur

• Sodium oxybate is the sodium salt of GHB—abuse or misuse of illicit GHB is associated with seizure, respiratory depression, decreased consciousness, coma, and death

• LUMRYZ is available only through a restricted program called the LUMRYZ REMS

Contraindications

LUMRYZ is contraindicated for use in :

• Combination with sedative hypnotics or alcohol

• Patients with succinic semialdehyde dehydrogenase deficiency

Most Common Adverse Reactions

In clinical trials, the most common adverse reactions in adults (incidence ≥5% and greater than placebo) were :

• Nausea

• Dizziness

• Enuresis (bed-wetting)

• Headache

• Vomiting

In pediatric patients, additional reactions included decreased weight, decreased appetite, and sleepwalking .

Additional Warnings 

• CNS depression: Caution against hazardous activities (driving, operating machinery) within the first 6 hours of dosing

• Depression and suicidality: Monitor for emergent or increased depression

• Confusion/Anxiety: May impair motor/cognitive function

• Parasomnias: Evaluate episodes of sleepwalking

• High sodium content: Monitor patients with heart failure, hypertension, or renal impairment

Disclaimer: This information is educational only and does not constitute medical advice. Consult a physician for complete prescribing information and to determine if LUMRYZ is appropriate for you or your patient.

How Does LUMRYZ Compare to Twice-Nightly Sodium Oxybate?

Comparison Table

What to Check Before Considering LUMRYZ

Before discussing LUMRYZ with a healthcare provider:

• Confirm diagnosis: LUMRYZ is specifically for narcolepsy with cataplexy or EDS

• Review medical history: Particularly any history of depression, suicidality, substance abuse, or breathing disorders

• List all medications: Especially other CNS depressants, sedatives, or stimulants

• Discuss sodium intake: LUMRYZ has high sodium content—relevant for patients with heart failure, hypertension, or renal impairment 

• Confirm REMS enrollment: LUMRYZ is only available through the LUMRYZ REMS restricted program

• Verify insurance coverage: As a specialty medication, coverage and costs vary

Red Flags to Discuss With a Physician:

• Unclear diagnosis or absence of specialist evaluation

• Prescriber not enrolled in LUMRYZ REMS

• Recommendations to use with alcohol or sedatives

• Recommendations to exceed 9g per night (not studied and not ordinarily recommended) 

Common Questions About LUMRYZ

1. What is LUMRYZ used for?

LUMRYZ is a prescription medication used to treat cataplexy or excessive daytime sleepiness in patients aged 7 years and older with narcolepsy .

2. How does LUMRYZ differ from XYREM?

While both contain sodium oxybate, LUMRYZ is an extended-release formulation taken once nightly, whereas XYREM is an immediate-release formulation taken twice nightly (at bedtime and 2.5–4 hours later) .

3. What is the recommended starting dose of LUMRYZ?

For adults, the recommended starting dose is 4.5g once per night, titrated in 1.5g increments weekly to a maintenance dose of 6g to 9g per night .

4. How is LUMRYZ taken?

Mix the powder from one packet with approximately ⅓ cup of water in the provided mixing cup, shake for 60 seconds, and consume within 30 minutes. Take at least 2 hours after eating, while in bed, and lie down immediately after dosing .

5. Can I switch from twice-nightly sodium oxybate to LUMRYZ?

Yes. Patients can switch at the nearest equivalent total nightly dose (e.g., 7.5g twice-nightly total to 7.5g LUMRYZ once nightly) .

6. Is LUMRYZ a controlled substance?

Yes. LUMRYZ is a Schedule III controlled substance because sodium oxybate is the sodium salt of GHB .

7. What is the LUMRYZ REMS?

The LUMRYZ REMS is a restricted distribution program requiring enrollment of prescribers, pharmacies, and patients because of the risks of CNS depression and abuse/misuse .

8. Is LUMRYZ approved for children?

LUMRYZ is approved for patients aged 7 years and older. For pediatric patients weighing less than 45 kg, another sodium oxybate product should be used to initiate treatment because the recommended starting dose cannot be achieved with available LUMRYZ strengths .

9. What are common side effects of LUMRYZ?

The most common side effects in adults include nausea, dizziness, enuresis (bed-wetting), headache, and vomiting .

10. Is LUMRYZ safe during pregnancy?

Based on animal data, LUMRYZ may cause fetal harm. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus .

How We Evaluated This Product

This product evaluation is based on:

• FDA prescribing information and package inserts

• Published clinical trial results (REST-ON phase 3 trial)

• Systematic reviews and meta-analyses of sodium oxybate

• Manufacturer documentation available in the public domain

• Regulatory information from the U.S. Food and Drug Administration

[Source needed] for any claims not attributed above; verification with official manufacturer documentation is recommended.

Author Bio Snippet

This content was prepared by an independent health content specialist with expertise in pharmaceutical product analysis and evidence-based medical communication. Information is drawn from peer-reviewed literature, regulatory documents, and manufacturer prescribing information. No personal use or clinical experience is claimed.

Disclaimer

This content is for educational and informational purposes only and does not constitute medical advice, diagnosis, or treatment. LUMRYZ is a prescription medication and should only be used under the supervision of a qualified healthcare provider. Always consult a physician or other qualified health professional with any questions regarding a medical condition or treatment. This page does not replace professional medical guidance, and users should not disregard or delay seeking medical advice based on information presented here. If you are experiencing a medical emergency, contact emergency services immediately.

Internal Link Suggestions

1. Narcolepsy: symptoms, diagnosis, and treatment options

2. The LUMRYZ REMS program or patient enrollment resources

3. Sodium oxybate options (LUMRYZ vs. Xyrem/Xywav)

4. Managing excessive daytime sleepiness in narcolepsy

5. Cataplexy and available treatments

External References

1.  Avadel CNS Pharmaceuticals, LLC – LUMRYZ Prescribing Information 

2.  FDA – LUMRYZ NDA Label Information 

3.  LUMRYZ Drug Information – NIH/National Library of Medicine 

4.  Sodium oxybate extended-release suspension (LUMRYZ™) in narcolepsy: a profile of its use – Springer 

5.  REST-ON trial results and post hoc analyses 

Entity & Topic Suggestions

1. Narcolepsy (sleep disorder)

2. Cataplexy (symptom)

3. Excessive Daytime Sleepiness (EDS)

4. Gamma-hydroxybutyrate (GHB)

5. Sodium oxybate pharmacology

6. REMS program (Risk Evaluation and Mitigation Strategy)

7. Sleep-wake cycle regulation