Sodium Oxybate
Sodium oxybate is a central nervous system depressant used to treat cataplexy and excessive daytime sleepiness in people with narcolepsy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 6 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Sodium oxybate carries two serious black-box warnings from the FDA: significant brain and breathing suppression, and a high potential for abuse and misuse.
This drug is a strong CNS depressant. Even at normal prescribed doses, it can cause dangerously slow or stopped breathing and deep, difficult-to-rouse sedation. The risk is much higher if you combine it with alcohol or sedative sleep medicines — these combinations are strictly forbidden.
Sodium oxybate is the prescription form of GHB, a drug that has been widely abused. Illicit GHB abuse has led to seizures, coma, and death. Because of these serious risks, sodium oxybate is only available through a tightly controlled program (the Sodium Oxybate REMS Program) — your prescriber must be specially certified and the pharmacy must be specially enrolled to dispense it.
📖 Sodium Oxybate: Patient Information Guide
A plain-language walkthrough of Sodium Oxybate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Sodium oxybate is used to treat symptoms of narcolepsy — specifically cataplexy and excessive daytime sleepiness.
- Cataplexy: Sudden, brief episodes of muscle weakness or paralysis usually triggered by strong emotions — treated with all supported sodium oxybate products
- Excessive daytime sleepiness (EDS): Overwhelming urges to sleep during the day despite nighttime sleep — treated with all supported sodium oxybate products
- Lumryz (extended-release oral suspension) is specifically approved for both cataplexy and EDS in patients 7 years of age and older with narcolepsy
- Xyrem (oral solution) is approved for both cataplexy and EDS in patients 7 years of age and older with narcolepsy
- Sodium oxybate oral solution (generic) is approved for cataplexy and EDS in patients with narcolepsy; the pediatric labeling is not included in the generic due to marketing exclusivity held by Xyrem
⚙️How it works▾
Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), a compound that occurs naturally in the brain as a byproduct of GABA — the brain's main calming neurotransmitter. Scientists believe it works by activating GABA-B receptors in areas of the brain that regulate alertness, muscle tone, and the sleep-wake cycle, including noradrenergic neurons (involved in arousal), dopaminergic neurons (involved in wakefulness and mood), and thalamocortical neurons (involved in sleep architecture). The precise way these actions reduce cataplexy and daytime sleepiness in narcolepsy is not fully understood.
💊How it's taken▾
How sodium oxybate is taken depends on the specific product prescribed.
- Lumryz (extended-release suspension): taken once nightly at bedtime as a single dose — no middle-of-the-night second dose required
- Xyrem and sodium oxybate oral solution: taken as two equal doses each night — the first at bedtime, the second 2.5 to 4 hours later (patients set an alarm)
- All forms should be taken at least 2 hours after the last meal; food significantly reduces how much the medicine is absorbed
- Always take your dose while already in bed and lie down immediately — the medicine works quickly and causes rapid sedation
Your prescriber will start you at a lower dose and gradually increase it based on how well it works and how you tolerate it. Never adjust your dose on your own, and follow your prescription label and pharmacist's instructions exactly.
🤒Side effects — in detail▾
Side effects are most common in the first few weeks of treatment and often lessen over time.
- Nausea — the most common reason people stop this medication
- Vomiting
- Dizziness
- Excessive sleepiness (somnolence)
- Bedwetting (enuresis) — particularly common
- Tremor (shakiness)
- Headache
- Decreased appetite and weight loss (reported especially in children)
- Sleepwalking (parasomnia)
- Diarrhea
Seek immediate medical attention for serious signs: severe breathing difficulty, inability to wake up, new or worsening depression or suicidal thoughts, seizures, or a sudden drop in consciousness. These require emergency care — do not wait.
⚠️Warnings & precautions▾
- CNS and respiratory depression: This is the most critical risk. Sodium oxybate slows the brain and breathing. Combining it with alcohol or sedative sleep aids is strictly forbidden. Mixing it with opioids, benzodiazepines, or other sedating drugs is extremely dangerous and should only happen under close medical supervision with careful dose adjustments.
- Abuse and misuse: Because sodium oxybate is chemically GHB — a controlled substance with a history of illicit use — it has significant potential for abuse. It is a Schedule III controlled substance and only available through a special restricted program (REMS). Prescribers and pharmacies must be specially certified.
- Depression and suicidality: Depression and suicidal thoughts have occurred in patients taking this medication. Caregivers and patients should watch for mood changes and report them promptly.
- Sleep-disordered breathing: Sodium oxybate can worsen breathing problems during sleep, particularly in people with sleep apnea. Sleepwalking has also been reported and should be evaluated by a doctor.
- High sodium content: This medication contains significant sodium, which may be a concern for patients with heart failure, high blood pressure, or kidney disease.
- No driving or hazardous activity for at least 6 hours after taking a dose.
🔀What it interacts with▾
Sodium oxybate has several critical drug and substance interactions that can be life-threatening.
- Alcohol: Absolutely prohibited — causes severe breathing suppression and, with Lumryz, may cause the full dose to release dangerously fast
- Sedative hypnotics (sleep aids): Contraindicated — cannot be used together
- Opioid pain medicines: Greatly increase risk of respiratory depression, profound sedation, and death; temporary opioids (e.g., post-surgery) may require pausing sodium oxybate
- Benzodiazepines: Dangerous additive CNS depression
- Sedating antidepressants, antipsychotics, or antiepileptic drugs: Increase sedation and breathing risk
- Muscle relaxants and general anesthetics: Can worsen CNS depression significantly
- Divalproex sodium (valproate): Raises sodium oxybate blood levels and worsens cognitive side effects; a dose reduction of sodium oxybate is needed if they must be used together
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not take sodium oxybate if you also take sedative sleep aids (sedative hypnotics) or drink alcohol
- Do not take it if you have succinic semialdehyde dehydrogenase deficiency — a rare metabolic condition
- Tell your doctor if you have liver disease — Lumryz should not be initiated in patients with hepatic impairment; the oral solution requires a reduced starting dose
- Tell your doctor if you have sleep apnea — sodium oxybate can increase the number of breathing pauses during sleep
- Tell your doctor if you have heart failure, high blood pressure, or kidney disease — the high sodium content may be harmful
- Pregnancy: Animal data suggest possible harm to the baby; discuss risks and benefits with your doctor before use
- Breastfeeding: GHB passes into breast milk; the risk to the infant is not fully known — talk to your doctor
- Older adults: May be more sensitive to side effects including falls, confusion, and impaired thinking; careful dose selection is important
- Children under 7: Safety and effectiveness have not been established
- Tell your doctor about any history of drug or substance abuse, as this medication has significant misuse potential
🚑If you take too much▾
Too much sodium oxybate can cause rapidly fluctuating levels of consciousness, confusion, agitation, vomiting, seizures, dangerously slowed or stopped breathing, coma, and potentially death. If you suspect an overdose, call 911 immediately or contact Poison Control at 1-800-222-1222. There is no specific reversal agent — treatment is supportive care focused on protecting the airway and monitoring vital signs.
📡Pharmacodynamics — effects in the body▾
Sodium oxybate acts as a CNS depressant, slowing brain activity in ways that can cause significant sedation, respiratory depression (slowed breathing), and temporary loss of consciousness at higher exposures. In narcolepsy clinical trials, it reduced episodes of cataplexy and improved wakefulness during the day, but it can also cause central sleep apnea (pauses in breathing during sleep) and oxygen desaturation in some patients. Its effects on the brain are rapid in onset, consistent with its short elimination half-life.
🔬Pharmacokinetics — how your body processes it▾
Sodium oxybate is rapidly absorbed after swallowing, with the oral solution reaching peak blood levels within about 30 to 75 minutes under fasting conditions; Lumryz (extended-release) reaches peak levels in about 1.5 hours. Eating a high-fat meal before the dose significantly delays absorption and reduces peak levels — this is why it must be taken at least 2 hours after eating. The body breaks down sodium oxybate almost entirely through normal metabolic pathways (primarily converting it to carbon dioxide and water via the Krebs cycle), so very little unchanged drug appears in the urine. Its half-life is very short — only 30 to 60 minutes — meaning it is cleared from the body quickly. In patients with liver cirrhosis, blood levels can be approximately double those seen in healthy adults, requiring dose adjustments.
📦How to store it▾
Keep out of reach of children. stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Dispense in tight containers.
📄 Written from Sodium Oxybate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Sodium Oxybate
25 supplements and herbal products have documented interactions with Sodium Oxybate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 15
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Sodium Oxybate — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I have to take two doses in the middle of the night — can't I just take it all at once? ▾
Can I have a glass of wine with dinner if I take my dose hours later at bedtime? ▾
This medication is related to GHB — is it safe? Is it addictive? ▾
I feel really nauseated after taking it — is that normal, and will it go away? ▾
My child is 9 years old and has narcolepsy — is this medication safe for kids? ▾
I take valproate (Depakote) for seizures — can I still use sodium oxybate? ▾
Is Sodium Oxybate available over the counter? ▾
Is Sodium Oxybate a controlled substance? ▾
When was Sodium Oxybate first available? ▾
Who makes Sodium Oxybate? ▾
💬 Answers drafted from Sodium Oxybate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Sodium Oxybate comes
Sodium Oxybate is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Extended-release oral suspension
How this form is used
- Lumryz is approved to treat cataplexy in patients 7 years of age and older with narcolepsy
- Lumryz is approved to treat excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
- Lumryz is taken as a single dose at bedtime — do not take a second dose during the night
- Lumryz should be taken at least 2 hours after eating; a high-fat meal significantly reduces absorption
- Do not mix Lumryz with alcohol or hot water (above 90°C/194°F), as either can cause the full dose to release all at once in a dangerous surge
- Lumryz may be mixed with room-temperature or warm (not hot) water, and calorie-free drink mixes or water flavorings do not affect how it releases
Oral solution
How this form is used
- Xyrem (oral solution) is approved to treat cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy
- Sodium oxybate oral solution is approved to treat cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy
- Xyrem and sodium oxybate oral solution are taken as two separate nightly doses — one at bedtime and a second dose 2.5 to 4 hours later; set an alarm for the second dose
- Prepare both doses before going to bed using the pharmacy-provided containers, diluting each dose with approximately ¼ cup of water
- Take each dose while already in bed and lie down immediately after taking it
- Wait at least 2 hours after eating before taking your first dose, as food significantly delays and reduces absorption
📊 Sodium Oxybate across the U.S. market
How Sodium Oxybate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (5) · Kit (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Sodium Oxybate is used
A general measure of how commonly Sodium Oxybate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sodium Oxybate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sodium Oxybate prescribed? Of the 1,596 medications we measure, Sodium Oxybate ranks #1,090 by Medicaid prescriptions — more than 32% of them.
Utilization by Sodium Oxybate product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Sodium Oxybate products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 2 of 29 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sodium Oxybate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 29 listed Sodium Oxybate NDCs with Medicaid activity.
🔍 Compare Sodium Oxybate products
A representative set of FDA-listed product records for Sodium Oxybate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Extended-release oral suspension | ||||
| 4.5 g | Oral | Avadel CNS Pharmaceuticals, LLC × 2 listings | NDA | View NDC → |
| 6 g | Oral | Avadel CNS Pharmaceuticals, LLC × 2 listings | NDA | View NDC → |
| 7.5 g | Oral | Avadel CNS Pharmaceuticals, LLC × 2 listings | NDA | View NDC → |
| 9 g | Oral | Avadel CNS Pharmaceuticals, LLC × 2 listings | NDA | View NDC → |
| 4.5 g | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 6 g | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 7.5 g | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 9 g | — | Catalent Pharma Solutions, LLC | DRUG FOR FURTHER PROCESSING | View NDC → |
| 4.5 g | — | Meribel Pharma Pessac | DRUG FOR FURTHER PROCESSING | View NDC → |
| 6 g | — | Meribel Pharma Pessac | DRUG FOR FURTHER PROCESSING | View NDC → |
| 7.5 g | — | Meribel Pharma Pessac | DRUG FOR FURTHER PROCESSING | View NDC → |
| 9 g | — | Meribel Pharma Pessac | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Oral solution | ||||
| 500 mg/mL | Oral | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 0.5 g/mL | Oral | Amneal Pharmaceuticals NY LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 0.5 g/mL | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 0.5 g/mL | Oral | Hikma Pharmaceuticals USA Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 0.5 g/mL | Oral | Jazz Pharmaceuticals, Inc. × 3 listings | NDA | View NDC → |
| 0.5 g/mL | Oral | XLCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 💊Kits | ||||
| — | — | Avadel CNS Pharmaceuticals, LLC | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Cambrex Charles City, Inc | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Chattem Chemicals, Inc. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Granules India Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 1 kg/kg | — | Siegfried USA, LLC | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Veranova, L.P. | BULK INGREDIENT | View NDC → |
Showing 31 of 31 products — FDA National Drug Code Directory. See every product, package size and price: browse all 31 Sodium Oxybate NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sodium Oxybate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sodium Oxybate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Sodium Oxybate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Sodium Oxybate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Sodium Oxybate belongs to the Central Nervous System Depressant class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Hikma Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.