- Raw materials
- Hypnotics
- Sodium oxybate
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Sodium oxybate | CAS No: 502-85-2 | GMP-certified suppliers
A medication that addresses cataplexy and excessive daytime sleepiness in narcolepsy, supporting treatment needs across major markets for reliable API sourcing.
Therapeutic categories
Acids, AcyclicAdjuvants, AnesthesiaAnestheticsAnesthetics, GeneralAnesthetics, IntravenousButyrates
Generic name
Sodium oxybate
Molecule type
small molecule
CAS number
502-85-2
DrugBank ID
DB09072
Approval status
Approved drug
ATC code
N01AX11
Primary indications
- Sodium oxybate is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy
- In the US and in Europe, the drug is approved for use in patients 7 years of age and older while in Canada, it is not recommended in children under the age of 18, unless clearly needed
Product Snapshot
- Sodium oxybate is an oral small‑molecule formulation supplied mainly as solutions and extended‑release suspensions
- It is used for managing cataplexy and excessive daytime sleepiness associated with narcolepsy
- It is approved in the US, EU, and Canada for these indications
Clinical Overview
Sodium oxybate is the sodium salt of gamma‑hydroxybutyric acid and is indicated for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy. It is approved in the United States and Europe for patients 7 years of age and older, while some regions advise against pediatric use unless clearly justified. Extended‑release sodium oxybate is available in selected markets, including the formulation marketed as Lumryz. In certain countries, the substance has also been studied for alcohol withdrawal syndrome and relapse prevention in alcohol use disorders.
Pharmacologically, sodium oxybate is a central nervous system depressant that modulates sleep architecture. Clinical effects include increased time spent in N2 and N3 sleep stages, reduced transitions to wake and REM sleep, and improved nocturnal sleep continuity. These changes correlate with reductions in excessive daytime sleepiness and improvements in cataplexy, with dose‑responsive effects observed for daytime alertness.
The drug exerts its actions through gamma‑hydroxybutyrate, which interacts with multiple receptor systems. At lower concentrations, GHB engages high‑ and low‑affinity GHB receptors, facilitating glutamate release. At higher concentrations, GHB activates GABA B receptors on noradrenergic, dopaminergic, and thalamocortical pathways involved in sleep–wake regulation. GHB is metabolized to GABA, contributing additional modulation at GABA A and GABA C receptors.
Sodium oxybate is rapidly absorbed, with extensive distribution and metabolic conversion through pathways shared with endogenous GHB. Elimination occurs primarily via biotransformation to carbon dioxide and water. Its potent CNS‑depressant effects introduce risks including respiratory depression, misuse, dependence, and withdrawal. Because of these concerns, access is restricted under controlled‑substance programs in several jurisdictions.
For API sourcing, manufacturers should ensure compliance with controlled‑substance regulations, maintain strict impurity control for GHB‑related intermediates, and confirm batch reproducibility due to the compound’s narrow safety margin and regulatory oversight.
Pharmacologically, sodium oxybate is a central nervous system depressant that modulates sleep architecture. Clinical effects include increased time spent in N2 and N3 sleep stages, reduced transitions to wake and REM sleep, and improved nocturnal sleep continuity. These changes correlate with reductions in excessive daytime sleepiness and improvements in cataplexy, with dose‑responsive effects observed for daytime alertness.
The drug exerts its actions through gamma‑hydroxybutyrate, which interacts with multiple receptor systems. At lower concentrations, GHB engages high‑ and low‑affinity GHB receptors, facilitating glutamate release. At higher concentrations, GHB activates GABA B receptors on noradrenergic, dopaminergic, and thalamocortical pathways involved in sleep–wake regulation. GHB is metabolized to GABA, contributing additional modulation at GABA A and GABA C receptors.
Sodium oxybate is rapidly absorbed, with extensive distribution and metabolic conversion through pathways shared with endogenous GHB. Elimination occurs primarily via biotransformation to carbon dioxide and water. Its potent CNS‑depressant effects introduce risks including respiratory depression, misuse, dependence, and withdrawal. Because of these concerns, access is restricted under controlled‑substance programs in several jurisdictions.
For API sourcing, manufacturers should ensure compliance with controlled‑substance regulations, maintain strict impurity control for GHB‑related intermediates, and confirm batch reproducibility due to the compound’s narrow safety margin and regulatory oversight.
Identification & chemistry
| Generic name | Sodium oxybate |
|---|---|
| Molecule type | Small molecule |
| CAS | 502-85-2 |
| UNII | 7G33012534 |
| DrugBank ID | DB09072 |
Pharmacology
| Summary | Sodium oxybate acts through its active compound, gamma‑hydroxybutyrate (GHB), which engages GHB receptors at lower concentrations and GABA(B) receptors at higher concentrations, influencing excitatory and inhibitory neurotransmission. These actions modulate thalamocortical and monoaminergic pathways involved in sleep–wake regulation, increasing slow‑wave sleep and improving sleep continuity. The drug produces central nervous system depressant effects consistent with its receptor activity profile. |
|---|---|
| Mechanism of action | The physiological actions of sodium oxybate are mediated by gamma-hydroxybutyrate (GHB), its active compound. While the exact mechanism of action of GHB in narcolepsy is not fully understood, it is suggested that GHB has multiple modes of action. At low doses, GHB binds to high- and low-affinity G-protein-coupled GHB receptors. Activation of GHB receptors leads to the release of glutamate, which is an excitatory neurotransmitter. At higher doses, GHB activates GABA<sub>B</sub> receptors at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons that are involved in sleep-wake regulation, attention and vigilance.GHB metabolizes to GABA, which modulates GABA<sub>A</sub> and GABA<sub>C</sub> receptors. |
| Pharmacodynamics | Sodium oxybate works to improve nocturnal sleep, improve alertness the following day, and ameliorate cataplexy. Decreased excessive daytime sleepiness in narcolepsy is observed in higher doses and at a delayed time.It is proposed that sodium oxybate increases the time spent in Stages N2 and N3 of sleep and decreases the shift to stages N1/Wake/REM,resulting in improved continuity of sleep and deeper sleep. Sodium oxybate is a central nervous system (CNS) depressant that can cause significant respiratory depression. Due to its physiological and psychological effects, sodium oxybate is associated with a risk for substance misuse and abuse,addiction, withdrawal syndrome, and overdoses.Sodium oxybate is a sodium salt of GHB, a naturally occurring CNS depressant that increases dopamine levels and increases serotonin turnover.Sodium oxybate stimulates growth hormone release, often leading to its misuse as a dietary supplement for bodybuilding.In patients with narcolepsy, sodium oxybate increases nocturnal growth hormone secretion and slow-wave sleep at night, which is when growth hormone is typically released. |
Targets
| Target | Organism | Actions |
|---|---|---|
| GABA(B) Receptor | agonist | |
| Gamma-hydroxybutyrate (GHB) receptor | Humans | agonist |
ADME / PK
| Absorption | Following oral administration of sodium oxybate, GHB is released and rapidly absorbed with an absolute bioavailability of about 88%. The plasma levels of GHB increases more than dose-proportionally, with blood levels increasing 3.7‐fold as total daily dose is doubled from 4.5 g to 9 g.After administration of a single oral dose of 2.25g to 4.5g sodium oxybate, the C<sub>max</sub> was 27–90 μg/mL and the mean T<sub>max</sub> ranged from 25 to 75 minutes. A high-fat meal delays absorption (average T<sub>max</sub> increased from 0.75 hr to 2 hr), reduces C<sub>max</sub> of GHB by 59%, and decreases systemic exposure (AUC) by 37%. |
|---|---|
| Half-life | GHB has an elimination half-life of 0.5 to 1 hour. |
| Protein binding | At GHB concentrations ranging from 3 mcg/mL to 300 mcg/mL, less than 1% is bound to plasma proteins. |
| Metabolism | Animal studies suggest that metabolism is the major elimination pathway for GHB, producing carbon dioxide and water via the tricarboxylic acid (Krebs) cycle and secondarily by beta-oxidation. GHB dehydrogenase, a cytosolic NADP<sup>+</sup>-linked enzyme, converts GHB to succinic semialdehyde, which is then biotransformed to succinic acid by succinic semialdehyde dehydrogenase. Succinic acid enters the Krebs cycle where it is metabolized to carbon dioxide and water. A second mitochondrial oxidoreductase enzyme, a transhydrogenase, also catalyzes the conversion to succinic semialdehyde in the presence of α-ketoglutarate. GHB can alternatively be converted to carbon dioxide and water via β-oxidation mediated by 3,4-dihydroxybutyrate. No active metabolites have been identified. |
| Route of elimination | The clearance of GHB is almost entirely by biotransformation to carbon dioxide, which is then eliminated by expiration. On average, less than 5% of unchanged drug appears in human urine within 6 to 8 hours after dosing. Fecal excretion is negligible. |
| Volume of distribution | The apparent volume of distribution of GHB ranges from 190 mL/kg to 384 mL/kg. |
| Clearance | In healthy GHB-naïve subjects who received a single oral dose of 25 mg GHB per kg of body weight, the total clearance 1228 ± 233 μL/min. |
Formulation & handling
- Oral formulations rely on the API’s very high aqueous solubility, enabling concentrated solutions and extended‑release suspensions without complex solubilization strategies.
- As a small hydrophilic molecule with low LogP, it is not suitable for lipid‑based delivery and is typically formulated as an aqueous sodium salt to maintain stability and handling consistency.
- Administration is recommended away from meals, so formulations should account for potential food‑related absorption delays and nighttime dosing conditions.
Regulatory status
| Lifecycle | Most U.S. patents covering the API have already expired, with the final group concluding in December 2024, indicating a transition toward late‑lifecycle status. With products marketed in the US, Canada, and the EU, the API is positioned in a mature market environment where generic competition is expected to increase. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | The market is supplied by a small number of originator manufacturers, with branded products such as Lumryz established in the United States, Canada, and the European Union. Branded formulations have broad presence across these regions, alongside non‑branded sodium oxybate products in some markets. Multiple key U.S. patents have already expired or will expire imminently, indicating that generic competition is present or likely to expand soon. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is 9690 mg/kg. There are several cases of GHB overdose in literature where individuals ingested GHB illicitly in conjunction with other drugs and alcohol. These individuals exhibited varying degrees of depressed consciousness that may fluctuate rapidly between a confusional, agitated, combative state with ataxia and coma. Emesis (even when obtunded), diaphoresis, headache, and impaired psychomotor skills have been observed. No typical pupillary changes have been described to assist in diagnosis; pupillary reactivity to light is maintained. Blurred vision has been reported. An increasing depth of coma and acidosis have been observed at higher doses. Myoclonus and tonic-clonic seizures have been reported. Respiration may be unaffected or compromised in rate and depth. Cheyne-Stokes respiration and apnea have been observed. Bradycardia and hypothermia may accompany unconsciousness, as well as muscular hypotonia, but tendon reflexes remain intact. In clinical trials, two adults experienced sodium oxybate overdose. One patient received an estimated dose of 150 g, which was more than 15 times the maximum recommended dose: this patient became unresponsive with brief periods of apnea and incontinent of urine and feces. The patient recovered without sequelae. The other patient died following a multiple drug overdose consisting of sodium oxybate and numerous other drugs. There is no known antidote for sodium oxybate; therefore, overdose should be managed with general symptomatic and supportive care, with a consideration of gastric decontamination if co-ingestants are suspected. |
|---|
High Level Warnings:
- Oral LD50 in rats is approximately 9690 mg/kg, indicating relatively low acute toxicity in rodent models but not predictive of human response
- Overdose scenarios are associated with CNS depression characterized by fluctuating consciousness, respiratory irregularities including apnea, and variable autonomic effects such as bradycardia and hypothermia
- No specific antidote is known
Sodium oxybate is a type of Hypnotics
Hypnotics belong to the pharmaceutical API category, which refers to a class of drugs primarily used to induce sleep or alleviate insomnia. These substances act on the central nervous system (CNS) to promote sedation and relaxation, aiding individuals in falling asleep and maintaining a healthy sleep pattern.
Hypnotics work through various mechanisms, targeting receptors and neurotransmitters involved in regulating sleep-wake cycles. They can enhance the activity of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter that reduces brain activity and induces sedation. By increasing GABAergic signaling, hypnotics help reduce anxiety, calm the mind, and facilitate sleep onset.
Commonly prescribed hypnotics include benzodiazepines, non-benzodiazepine receptor agonists, and melatonin receptor agonists. Benzodiazepines, such as diazepam and temazepam, bind to GABA receptors, intensifying the inhibitory effects of GABA. Non-benzodiazepine receptor agonists like zolpidem and zopiclone act selectively on certain GABA receptors, inducing sleep without causing significant muscle relaxation or antianxiety effects. Melatonin receptor agonists like ramelteon mimic the effects of melatonin, a hormone that regulates the sleep-wake cycle.
Hypnotics are widely prescribed for individuals experiencing sleep disturbances due to various conditions, including insomnia, jet lag, shift work disorder, or other sleep-related disorders. These APIs are manufactured by pharmaceutical companies and can be formulated into different dosage forms, including tablets, capsules, or liquid preparations.
It's essential to note that the use of hypnotics should be carefully monitored, as prolonged or excessive use may lead to dependence, tolerance, or adverse effects. Therefore, consultation with a healthcare professional is necessary to ensure safe and appropriate use of hypnotics for optimal sleep management.
Frequently asked questions about Sodium oxybate API
Sourcing
What matters most when sourcing GMP-grade Sodium oxybate?
Key considerations include confirming compliance with GMP standards and meeting regulatory requirements in the United States, Canada, and the European Union. Because the market is supplied by a small number of originator manufacturers, assessing supplier reliability and capacity is essential. It is also important to understand the presence of branded and non‑branded Sodium oxybate products and the evolving landscape as key U.S. patents expire and generic competition increases.
Which documents are typically required when sourcing Sodium oxybate API?
Request the core API documentation set: CoA (5 companies), GMP (3 companies), USDMF (3 companies), MSDS (2 companies), WC (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Sodium oxybate API?
Known or reported manufacturers for Sodium oxybate: Duchefa Farma B.V.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Sodium oxybate API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Sodium oxybate manufacturers?
Audit reports may be requested for Sodium oxybate: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Sodium oxybate API on Pharmaoffer?
Reported supplier count for Sodium oxybate: 5 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Sodium oxybate API?
Production countries reported for Sodium oxybate: India (2 producers), Germany (1 producer), United States (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Sodium oxybate usually hold?
Common certifications for Sodium oxybate suppliers: CoA (5 companies), GMP (3 companies), USDMF (3 companies), MSDS (2 companies), WC (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Sodium oxybate (CAS 502-85-2) used for?
Sodium oxybate is used to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, including those 7 years of age and older in regions where it is approved. It acts as a central nervous system depressant that modifies sleep architecture to reduce daytime symptoms. In some countries, it has also been studied for alcohol withdrawal syndrome and relapse prevention in alcohol use disorders.
Which therapeutic class does Sodium oxybate fall into?
Sodium oxybate belongs to the following therapeutic categories: Acids, Acyclic, Adjuvants, Anesthesia, Anesthetics, Anesthetics, General, Anesthetics, Intravenous. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Sodium oxybate mainly prescribed for?
The primary indications for Sodium oxybate: Sodium oxybate is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy, In the US and in Europe, the drug is approved for use in patients 7 years of age and older while in Canada, it is not recommended in children under the age of 18, unless clearly needed. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Sodium oxybate work?
The physiological actions of Sodium oxybate are mediated by gamma-hydroxybutyrate (GHB), its active compound. While the exact mechanism of action of GHB in narcolepsy is not fully understood, it is suggested that GHB has multiple modes of action.
At low doses, GHB binds to high- and low-affinity G-protein-coupled GHB receptors. Activation of GHB receptors leads to the release of glutamate, which is an excitatory neurotransmitter. At higher doses, GHB activates GABAB receptors at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons that are involved in sleep-wake regulation, attention and vigilance.GHB metabolizes to GABA, which modulates GABAA and GABAC receptors.
What should someone know about the safety or toxicity profile of Sodium oxybate?
Sodium oxybate has a relatively low acute toxicity in rodents, but this does not predict human response, and the drug carries significant CNS‑depressant risks. Overdose may cause fluctuating consciousness, respiratory irregularities including apnea, and autonomic effects such as bradycardia and hypothermia; no specific antidote is available. Its depressant properties also create risks of misuse, dependence, and withdrawal, leading to controlled‑substance restrictions in several regions. Manufacturers must maintain strict control of impurities and batch consistency due to the compound’s narrow safety margin.
What are important formulation and handling considerations for Sodium oxybate as an API?
Sodium oxybate is typically formulated as an aqueous sodium salt due to its very high water solubility and hydrophilic, low‑LogP profile, which supports concentrated solutions or extended‑release suspensions without additional solubilizers. Formulations should avoid lipid‑based systems and consider administration away from meals because high‑fat food delays absorption and reduces exposure. Handling considerations focus on maintaining solution stability and ensuring consistent dosing for nighttime use.
Is Sodium oxybate a small molecule?
Sodium oxybate is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Sodium oxybate?
Oral Sodium oxybate is typically formulated as an aqueous sodium salt, which provides inherent physicochemical stability due to its high water solubility. Stability considerations mainly relate to maintaining the integrity of concentrated aqueous solutions or suspensions, with no need for complex solubilization approaches. Because administration is recommended away from meals, formulations should remain stable under fasting and nighttime dosing conditions. No additional special stability concerns are indicated in the provided context.
Regulatory
Where is Sodium oxybate approved or in use globally?
Sodium oxybate is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Sodium oxybate right now?
Sodium oxybate is regulated as a controlled and authorized active substance in the United States, Canada, and the European Union, with each region applying its standard approval and safety frameworks for this class of compounds. Patent protection for the substance and related formulations is jurisdiction‑specific and managed through national and regional intellectual‑property systems, which govern exclusivity periods and any applicable expirations.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Sodium oxybate procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Sodium oxybate. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Sodium oxybate included in the PRO Data Insights coverage?
PRO Data Insights coverage for Sodium oxybate: 89 verified transactions across 12 suppliers and 6 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Sodium oxybate?
Market report availability for Sodium oxybate: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
