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- Pentobarbital
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Pentobarbital API from Germany Manufacturers & Suppliers
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Pentobarbital | CAS No: 76-74-4 | GMP-certified suppliers
A medication that supports short-term relief of insomnia by providing reliable sedative effects suitable for inclusion in sleep-management formulations across key markets.
Therapeutic categories
Adjuvants, AnesthesiaAnticholinergic AgentsAnticonvulsantsBarbituratesBarbiturates, PlainCentral Nervous System Agents
Generic name
Pentobarbital
Molecule type
small molecule
CAS number
76-74-4
DrugBank ID
DB00312
Approval status
Approved drug, Investigational drug, Vet_approved drug
ATC code
N05CB01
Primary indications
- For the short-term treatment of insomnia
Product Snapshot
- Pentobarbital is available as an oral, injectable, and rectal small‑molecule barbiturate
- Its primary therapeutic use is short‑term management of insomnia
- It is approved in the US and Canada with additional investigational and veterinary approval statuses
Clinical Overview
Pentobarbital (CAS 76-74-4) is a short-acting barbiturate used primarily for the short-term management of insomnia. It is classified as a pyrimidinone derivative, consistent with its six‑membered heterocyclic ring containing two nitrogen atoms and a ketone. Clinically, its use is limited to short-duration sleep induction due to tolerance that can develop within one to two weeks of continuous administration. In human and veterinary practice, formulations historically marketed under names such as Nembutal have been used in controlled settings for sedation and seizure management.
Pharmacologically, pentobarbital is a central nervous system depressant with hypnotic and sedative properties. It provides minimal analgesia and may provoke paradoxical excitation when administered in the presence of pain. Its primary action is potentiation of GABAergic neurotransmission through binding to a distinct site on the GABAA receptor complex, increasing the duration of chloride channel opening and enhancing postsynaptic inhibition in thalamic and cortical pathways. The compound also suppresses excitatory neurotransmission by directly inhibiting AMPA‑type glutamate receptors.
Pentobarbital undergoes hepatic metabolism, involving CYP2C19 and CYP3A pathways, and exhibits enzyme‑inducing properties that can alter the disposition of coadministered substrates processed by CYP2A6, CYP3A, and CYP3A4. Renal excretion contributes to elimination, primarily as metabolites. Sedation intensity, onset, and duration vary with dose, route, and hepatic function.
Safety considerations include dose‑dependent respiratory depression, hypotension, impaired psychomotor performance, and risk of dependence with repeated use. Paradoxical reactions, including agitation, may occur, particularly in individuals with underlying pain or neurological disorders. Drug interactions influenced by hepatic enzyme induction are clinically relevant during multi‑drug therapy.
For API procurement, sourcing should prioritize verified identity, impurity control aligned with barbiturate monograph expectations, and manufacturing routes that ensure low residual solvents. Consistency in particle characteristics and stability data is essential for reliable formulation performance and regulatory compliance.
Pharmacologically, pentobarbital is a central nervous system depressant with hypnotic and sedative properties. It provides minimal analgesia and may provoke paradoxical excitation when administered in the presence of pain. Its primary action is potentiation of GABAergic neurotransmission through binding to a distinct site on the GABAA receptor complex, increasing the duration of chloride channel opening and enhancing postsynaptic inhibition in thalamic and cortical pathways. The compound also suppresses excitatory neurotransmission by directly inhibiting AMPA‑type glutamate receptors.
Pentobarbital undergoes hepatic metabolism, involving CYP2C19 and CYP3A pathways, and exhibits enzyme‑inducing properties that can alter the disposition of coadministered substrates processed by CYP2A6, CYP3A, and CYP3A4. Renal excretion contributes to elimination, primarily as metabolites. Sedation intensity, onset, and duration vary with dose, route, and hepatic function.
Safety considerations include dose‑dependent respiratory depression, hypotension, impaired psychomotor performance, and risk of dependence with repeated use. Paradoxical reactions, including agitation, may occur, particularly in individuals with underlying pain or neurological disorders. Drug interactions influenced by hepatic enzyme induction are clinically relevant during multi‑drug therapy.
For API procurement, sourcing should prioritize verified identity, impurity control aligned with barbiturate monograph expectations, and manufacturing routes that ensure low residual solvents. Consistency in particle characteristics and stability data is essential for reliable formulation performance and regulatory compliance.
Identification & chemistry
| Generic name | Pentobarbital |
|---|---|
| Molecule type | Small molecule |
| CAS | 76-74-4 |
| UNII | I4744080IR |
| DrugBank ID | DB00312 |
Pharmacology
| Summary | Pentobarbital enhances inhibitory GABAergic signaling by binding to a distinct site on GABAA receptors and prolonging chloride channel opening, leading to reduced neuronal excitability. It also suppresses excitatory transmission through direct inhibition of AMPA‑type glutamate receptors. These actions produce broad CNS depressant effects relevant to its short‑term use in insomnia. |
|---|---|
| Mechanism of action | Pentobarbital binds at a distinct binding site associated with a Cl- ionopore at the GABAA receptor, increasing the duration of time for which the Cl- ionopore is open. The post-synaptic inhibitory effect of GABA in the thalamus is, therefore, prolonged. All of these effects are associated with marked decreases in GABA-sensitive neuronal calcium conductance (gCa). The net result of barbiturate action is acute potentiation of inhibitory GABAergic tone. Barbiturates also act through potent (if less well characterized) and direct inhibition of excitatory AMPA-type glutamate receptors, resulting in a profound suppression of glutamatergic neurotransmission. |
| Pharmacodynamics | Pentobarbital, a barbiturate, is used for the treatment of short term insomnia. It belongs to a group of medicines called central nervous system (CNS) depressants that induce drowsiness and relieve tension or nervousness. Little analgesia is conferred by barbiturates; their use in the presence of pain may result in excitation. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Gamma-aminobutyric acid receptor subunit alpha-1 | Humans | potentiator |
| Gamma-aminobutyric acid receptor subunit alpha-2 | Humans | potentiator |
| Gamma-aminobutyric acid receptor subunit alpha-3 | Humans | potentiator |
ADME / PK
| Absorption | Barbiturates are absorbed in varying degrees following oral, rectal, or parenteral administration. |
|---|---|
| Half-life | 5 to 50 hours (dose dependent) |
| Metabolism | by hepatic microsomal enzyme system |
| Route of elimination | Barbiturates are metabolized primarily by the hepatic microsomal enzyme system, and the metabolic products are excreted in the urine, and less commonly, in the feces. Approximately 25 to 50 percent of a dose of aprobarbital or phenobarbital is eliminated unchanged in the urine, whereas the amount of other barbiturates excreted unchanged in the urine is negligible. |
Formulation & handling
- Pentobarbital is a small‑molecule barbiturate formulated for oral, rectal, and parenteral use, with moderate lipophilicity that supports absorption across multiple routes.
- Low aqueous solubility requires cosolvents or pH adjustment for injectable solutions to maintain stability and prevent precipitation.
- As a solid-state API, it is chemically stable under normal handling but sensitive to hydrolysis in solution, necessitating controlled pH and appropriate antioxidants or buffers during formulation.
Regulatory status
| Lifecycle | Patent status in Canada and the US determines whether the API remains in a protected phase or has transitioned to a mature, post‑expiry market. In both markets, lifecycle maturity will align with the timing of exclusivity loss, after which competition typically increases and market dynamics stabilize. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Several originator and legacy manufacturers, along with multiple packagers, indicate a mature and diversified supply base for pentobarbital. Branded products such as Nembutal have historical presence in the US and Canada, with limited global brand penetration beyond these markets. Patent expiry occurred long ago, so generic manufacturers are established and ongoing competition is already part of the supply landscape. |
|---|
Safety
| Toxicity | Symptoms of an overdose typically include sluggishness, incoordination, difficulty in thinking, slowness of speech, faulty judgment, drowsiness or coma, shallow breathing, staggering, and in severe cases coma and death. |
|---|
High Level Warnings:
- Overexposure is associated with central nervous system depression characterized by impaired coordination, slowed cognitive processing, altered judgment, and progressive sedation
- Severe toxicity may present with respiratory depression and loss of consciousness
- Risk escalates with higher systemic concentrations
Pentobarbital is a type of Barbiturates
Barbiturates are a category of pharmaceutical active pharmaceutical ingredients (APIs) that have sedative, hypnotic, and anticonvulsant properties. They belong to the class of drugs called depressants, which slow down the central nervous system (CNS) activity. Barbiturates have been widely used in the medical field for their ability to induce sleep, reduce anxiety, and control seizures.
The mechanism of action of barbiturates involves enhancing the effects of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain. GABA inhibits the transmission of signals between nerve cells, leading to relaxation and sedation. Barbiturates bind to specific GABA receptors, increasing the inhibitory effects of GABA and resulting in a calming effect on the CNS.
In the past, barbiturates were commonly prescribed for insomnia, anxiety disorders, and epilepsy. However, their use has decreased significantly due to the emergence of safer and more effective alternatives with fewer side effects. Nonetheless, barbiturates are still utilized in certain medical situations, such as anesthesia induction, emergency seizure control, and in some cases of refractory epilepsy.
Despite their therapeutic benefits, barbiturates carry potential risks and side effects. They can cause drowsiness, impaired coordination, and dependence when used for extended periods. Overdose of barbiturates can be life-threatening, leading to respiratory depression and coma.
In conclusion, barbiturates are a class of API widely known for their sedative, hypnotic, and anticonvulsant properties. While their use has diminished over time, they remain important in specific medical contexts. Proper caution and medical supervision are crucial when using barbiturates to ensure safety and efficacy.
Frequently asked questions about Pentobarbital API
Sourcing
What matters most when sourcing GMP-grade Pentobarbital?
When sourcing GMP‑grade Pentobarbital, the key considerations are compliance with applicable US and Canadian regulatory requirements and verification of GMP documentation. A mature, diversified supply base means multiple qualified manufacturers and packagers exist, but each source still requires assessment of quality systems and regulatory status. Ensuring traceable origin and consistency across batches is essential given the range of originator and legacy producers.
Which documents are typically required when sourcing Pentobarbital API?
Request the core API documentation set: GMP (2 companies), CoA (2 companies), FDA (1 company), CEP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Pentobarbital API?
Known or reported manufacturers for Pentobarbital: Hänseler AG. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Pentobarbital 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 Pentobarbital manufacturers?
Audit reports may be requested for Pentobarbital: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Pentobarbital API on Pharmaoffer?
Reported supplier count for Pentobarbital: 2 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Pentobarbital API?
Production countries reported for Pentobarbital: Germany (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Pentobarbital usually hold?
Common certifications for Pentobarbital suppliers: GMP (2 companies), CoA (2 companies), FDA (1 company), CEP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Pentobarbital (CAS 76-74-4) used for?
Pentobarbital is a short‑acting barbiturate used for the short‑term management of insomnia and for controlled sedation in clinical settings. It has also been employed in human and veterinary practice for seizure management. Its effects arise from potentiation of GABAA‑mediated inhibition and suppression of AMPA‑type excitatory signaling.
Which therapeutic class does Pentobarbital fall into?
Pentobarbital belongs to the following therapeutic categories: Adjuvants, Anesthesia, Anticholinergic Agents, Anticonvulsants, Barbiturates, Barbiturates, Plain. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Pentobarbital mainly prescribed for?
The primary indications for Pentobarbital: For the short-term treatment of insomnia. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Pentobarbital work?
Pentobarbital binds at a distinct binding site associated with a Cl- ionopore at the GABAA receptor, increasing the duration of time for which the Cl- ionopore is open. The post-synaptic inhibitory effect of GABA in the thalamus is, therefore, prolonged. All of these effects are associated with marked decreases in GABA-sensitive neuronal calcium conductance (gCa). The net result of barbiturate action is acute potentiation of inhibitory GABAergic tone. Barbiturates also act through potent (if less well characterized) and direct inhibition of excitatory AMPA-type glutamate receptors, resulting in a profound suppression of glutamatergic neurotransmission.
What should someone know about the safety or toxicity profile of Pentobarbital?
Pentobarbital produces dose‑dependent central nervous system depression, leading to impaired coordination, slowed cognition, altered judgment, and progressive sedation. Severe toxicity can involve respiratory depression, hypotension, and loss of consciousness, with higher systemic levels increasing risk. Paradoxical agitation may occur, especially in individuals with pain or neurologic conditions. Repeated use can lead to dependence, and hepatic enzyme induction may alter the effects of other drugs metabolized through CYP pathways.
What are important formulation and handling considerations for Pentobarbital as an API?
Formulation of Pentobarbital requires managing its low aqueous solubility, often using cosolvents or pH adjustment to maintain a stable, non‑precipitating injectable solution. Because the API is prone to hydrolysis in solution, controlled pH and suitable buffering or antioxidant systems are important. The solid-state material is chemically stable under normal handling, but solutions should be protected from conditions that promote degradation. Careful excipient selection is needed to support stability across oral, rectal, and parenteral routes.
Is Pentobarbital a small molecule?
Pentobarbital is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Pentobarbital?
Oral Pentobarbital is generally stable as a solid-state API, but it is sensitive to hydrolysis once in solution. Formulated products need controlled pH to limit degradation, as barbiturates can break down in aqueous environments. Its low aqueous solubility is not usually a stability issue for solid oral forms but is relevant when solutions are prepared. No additional stability concerns beyond pH control and protection from moisture are noted in the provided context.
Regulatory
Where is Pentobarbital approved or in use globally?
Pentobarbital is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Pentobarbital procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Pentobarbital. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Pentobarbital included in the PRO Data Insights coverage?
PRO Data Insights coverage for Pentobarbital: 92 verified transactions across 24 suppliers and 14 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Pentobarbital?
Market report availability for Pentobarbital: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
