Description

 

lumryz medication

What Is LUMRYZ (Sodium Oxybate)?

LUMRYZ (sodium oxybate) for extended-release oral suspension is the first and only once-nightly extended-release formulation of sodium oxybate approved by the FDA for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy .

Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), a central nervous system depressant. LUMRYZ is supplied as a white to off-white powder in pre-measured packets available in 4.5 g, 6 g, 7.5 g, and 9 g strengths . Each dose is mixed with approximately 1/3 cup of water (approximately 80 mL) using the provided mixing cup and consumed within 30 minutes of preparation .

What this means: LUMRYZ provides a full therapeutic dose of sodium oxybate in a single bedtime administration, avoiding the need for a middle-of-the-night waking dose required by traditional formulations .

What Does LUMRYZ Treat?

LUMRYZ is FDA-approved for two core symptoms of narcolepsy:

1. Cataplexy — sudden, brief episodes of muscle weakness triggered by strong emotions such as laughter, anger, or surprise 

2. Excessive Daytime Sleepiness (EDS) — overwhelming and persistent daytime sleepiness that interferes with daily functioning 

Narcolepsy is a chronic neurological condition characterized by sleep-wake instability. Clinical trial evidence from the REST-ON study demonstrated statistically significant and clinically meaningful improvements in both cataplexy frequency and ability to stay awake during the day for patients taking LUMRYZ compared with placebo . lumryz medication

Who Is LUMRYZ For?

LUMRYZ is indicated for patients 7 years of age and older with narcolepsy who experience cataplexy or excessive daytime sleepiness .

Patient populations by weight for pediatric patients :

[For pediatric patients weighing less than 45 kg, the recommended starting dosage cannot be achieved with available strengths of LUMRYZ; use another sodium oxybate product to initiate treatment] .

Who Is LUMRYZ NOT For?

LUMRYZ is contraindicated in the following patients :

• Patients taking sedative hypnotics

• Patients consuming alcohol (concurrent use)

• Patients with succinic semialdehyde dehydrogenase deficiency (a rare metabolic disorder)

Caution is advised for patients with :

• Hepatic impairment (LUMRYZ should not be initiated)

• Renal impairment

• Pulmonary impairment or sleep apnea

• Heart failure, hypertension, or sodium-restricted diets (high sodium content)

• History of depression, suicidality, or psychiatric disorders

• History of substance abuse

Patients should not engage in hazardous activities requiring full mental alertness, including driving or operating machinery, for at least 6 hours after taking LUMRYZ .

What Are the Key Features of LUMRYZ?

1. Once-Nightly Extended-Release Dosing

LUMRYZ is administered as a single dose at bedtime. Patients take the dose while in bed and lie down immediately after, as LUMRYZ may cause sudden sleep onset, often within 5–15 minutes .

2. Full Therapeutic Dose Delivery

The extended-release formulation delivers sodium oxybate gradually over the night, providing therapeutic exposure throughout the sleep period .

3. Proprietary Extended-Release Formulation

Each pre-measured packet contains a proprietary blend of immediate-release and controlled-release granules designed to provide sustained therapeutic levels .

4. Pre-Measured Packets

LUMRYZ eliminates the need for measuring liquid doses from a multi-dose bottle. Each packet contains a pre-measured strength .

5. Pediatric Approval

LUMRYZ is the only once-nightly oxybate approved for pediatric patients aged 7 years and older with narcolepsy .

6. Restricted REMS Program

Due to risks of CNS depression and abuse/misuse, LUMRYZ is available only through the LUMRYZ REMS, a restricted distribution program involving specially certified prescribers, pharmacies, and enrolled patients .

Technical Specifications

How Does LUMRYZ Compare with Other Sodium Oxybate Formulations?

What this means: The primary distinction between LUMRYZ and traditional sodium oxybate is dosing convenience. LUMRYZ eliminates the middle-of-the-night waking dose, which clinical research suggests may improve patient compliance and sleep quality . In a switching study, most patients preferred the once-nightly formulation .

What Are the Verified Benefits?

The following benefits are supported by clinical trial evidence from the REST-ON Phase 3 trial :

Clinically Proven Improvements :

• Increased daytime sleep latency — ability to stay awake longer during the day, measured by the Maintenance of Wakefulness Test (MWT)

• Reduced cataplexy attacks — statistically significant reduction in weekly cataplexy episodes

• Reduced daytime sleepiness — measured by the Epworth Sleepiness Scale (ESS)

• Improved disrupted nighttime sleep (DNS) — reduced sleep transitions and arousals, improved sleep quality

Patient-Reported Outcomes :

• Significant improvements in subjective sleep quality

• More refreshing nature of sleep

• Benefits observed with all evaluated doses (6 g, 7.5 g, and 9 g)

Patient Preference :

• Most patients who switched from twice-nightly immediate-release sodium oxybate to once-nightly LUMRYZ preferred the once-nightly formulation

Key Clinical Trial Finding:

“Once-nightly sodium oxybate ER demonstrated statistically significant and clinically meaningful improvement relative to placebo for all three co-primary endpoints [MWT, CGI-I, and weekly cataplexy attacks]” 

What Are the Important Safety Considerations?

Boxed Warning (FDA)

LUMRYZ carries a boxed warning for central nervous system depression and abuse/misuse .

CNS Depression:

• Clinically significant respiratory depression can occur at recommended doses

• Use with other CNS depressants increases risks including respiratory depression, hypotension, profound sedation, and death 

Abuse and Misuse:

• Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB)

• GHB abuse is associated with seizure, respiratory depression, decreased consciousness, coma, and death 

LUMRYZ REMS Program

Because of these risks, LUMRYZ is available only through a restricted program requiring :

• Specially certified healthcare providers for prescribing

• Specially certified pharmacies for dispensing

• Patient enrollment with documentation of safe use conditions

Contact for REMS: 1-877-453-1029 or www.LUMRYZREMS.com 

Common Adverse Reactions

In adults (incidence ≥5% and greater than placebo) :

• Nausea

• Dizziness

• Enuresis (bed-wetting)

• Headache

• Vomiting

In pediatric patients (≥5% in a study with immediate-release sodium oxybate) :

• Nausea

• Enuresis

• Vomiting

• Headache

• Weight decreased

• Decreased appetite

• Dizziness

• Sleepwalking

High Sodium Content

Each dose contains significant sodium :

Patients with heart failure, hypertension, or impaired renal function should be monitored. Consider daily sodium intake and dietary sources .

What Should Buyers or Patients Check Before Using LUMRYZ?

1. Verify Prescribing Information with the Manufacturer

• LUMRYZ is a prescription-only medication. All information on this page should be verified with official manufacturer documentation 

• Full Prescribing Information including Boxed Warning is available from Avadel CNS Pharmaceuticals

2. Confirm REMS Enrollment

• LUMRYZ is available only through the LUMRYZ REMS program 

• Confirm that your healthcare provider and pharmacy are certified

• Ensure you are enrolled in the program before attempting to obtain the medication

3. Discuss Medical History with Healthcare Provider

• Inform your provider about any history of :

  • Sleep apnea or respiratory conditions

  • Liver disease (hepatic impairment)

  • Kidney disease (renal impairment)

  • Depression or suicidal thoughts

  • Substance abuse history

  • Heart failure, hypertension, or sodium-restricted diet

4. Review Current Medications

• LUMRYZ is contraindicated with sedative hypnotics and alcohol 

• Use with other CNS depressants requires careful consideration 

5. Verify Authenticity and Packaging

• LUMRYZ is distributed in pre-measured packets with NDC codes 

• [Verify official packaging and appearance with manufacturer documentation]

• [Serial number verification information not available; contact manufacturer]

6. Understand Administration Requirements

• Take at least 2 hours after eating 

• Take while in bed and lie down immediately after 

• Consume within 30 minutes of mixing 

• Prepare only prior to bedtime 

7. Report Adverse Events

• Contact Avadel CNS Pharmaceuticals at 1-888-828-2335

• Contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 

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Common Questions About LUMRYZ

What is LUMRYZ?

LUMRYZ is an FDA-approved prescription medication containing sodium oxybate, taken once nightly as an extended-release oral suspension. It is used to treat cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy .

How is LUMRYZ different from Xyrem?

Both contain sodium oxybate, but LUMRYZ is an extended-release formulation taken once at bedtime. Xyrem is an immediate-release liquid taken in two doses — at bedtime and again 2.5–4 hours later. LUMRYZ was approved in 2023, while Xyrem was approved in 2002 .

Who can prescribe LUMRYZ?

Only specially certified healthcare providers enrolled in the LUMRYZ REMS program can prescribe LUMRYZ. Pharmacies that dispense it must also be specially certified .

Is LUMRYZ a controlled substance?

Yes. LUMRYZ is classified as a Schedule III controlled substance. Its active ingredient, sodium oxybate, is the sodium salt of GHB, which is a Schedule I substance when misused .

What are the most common side effects?

The most common side effects in adults are nausea, dizziness, bed-wetting, headache, and vomiting. Pediatric patients may also experience weight loss, decreased appetite, and sleepwalking .

Can I take LUMRYZ with other medications?

LUMRYZ is contraindicated with sedative hypnotics and alcohol. Use with other CNS depressants may increase risks. Always discuss all medications with your healthcare provider .

How much sodium is in LUMRYZ?

Each dose contains 820 mg (4.5 g) to 1640 mg (9 g) of sodium. This is important for patients on sodium-restricted diets or with heart or kidney conditions .

Is LUMRYZ approved for children?

Yes. In October 2024, FDA approved LUMRYZ for patients 7 years and older with narcolepsy. Dosing is based on body weight .

How long does it take to work?

Patients often fall asleep within 5–15 minutes of taking LUMRYZ. Clinical benefits for daytime sleepiness and cataplexy were observed during the 13-week REST-ON trial .

Can I drive after taking LUMRYZ?

No. Patients should not engage in hazardous activities requiring mental alertness or motor coordination, including driving or operating machinery, for at least 6 hours after taking LUMRYZ .

Conclusion

LUMRYZ (sodium oxybate) for extended-release oral suspension is an FDA-approved once-nightly treatment option for cataplexy and excessive daytime sleepiness in patients 7 years and older with narcolepsy. Supported by clinical trial evidence from the REST-ON study, it offers a single-dose alternative to twice-nightly sodium oxybate formulations .lumryz narcolepsy

Due to the risks of CNS depression and abuse/misuse, LUMRYZ is available only through a restricted REMS program, requiring patient enrollment and participation from certified healthcare providers and pharmacies .

Patients should verify all prescribing information with official manufacturer documentation and discuss medical history, current medications, and sodium intake considerations with their healthcare provider before use .lumryz narcolepsy

Disclaimer

This page is for educational and informational purposes only. It is not intended as medical advice, professional prescribing information, or a substitute for consultation with a qualified healthcare provider. All medication information should be verified with the manufacturer’s Full Prescribing Information, including the Boxed Warning, and through consultation with a licensed healthcare professional. Individual patient response, risks, and suitability vary. This page does not constitute a recommendation or endorsement of any specific treatment. The manufacturer ([Verify with official manufacturer documentation]) should be consulted for complete and current product information.

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. FDA Labeling Information — LUMRYZ Prescribing Information 

   • www.accessdata.fda.gov

2. DailyMed — NIH National Library of Medicine 

   • www.dailymed.nlm.nih.gov

3. LUMRYZ REMS — Official REMS Program Information 

   • www.LUMRYZREMS.com

4. AASM — American Academy of Sleep Medicine 

   • www.aasm.org

5. Clinical Trial Publication (REST-ON) — Kushida CA, et al. Sleep. 2022 

   • [PubMed/Journal reference available]

Entity & Topic Suggestions

1. Sodium oxybate — active pharmaceutical ingredient

2. Narcolepsy — primary indication

3. Cataplexy — condition treated

4. Excessive daytime sleepiness — condition treated

5. GHB (gamma-hydroxybutyrate) — pharmacologically related substance

6. REST-ON trial — Phase 3 clinical trial

7. REMS (Risk Evaluation and Mitigation Strategy) — restricted distribution program