Pentobarbital

Mechanism-of-action class: Neurotransmitter Transporter Interactions.

• Parenteral Sedatives. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See " Clinical Pharmacology " section).ICD-10: G47.00

• Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria.contraindicated

Dosages of barbiturates must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical. Intramuscular Administration IM injection of the sodium salts of barbiturates should be made deeply into a large muscle, and a volume of 5 mL should not be exceeded at any one site because of possible tissue irritation. After IM injection of a hypnotic dose, the patient's vital signs should be monitored. The usual adult dosage of Pentobarbital Sodium is 150 to 200 mg as a single IM injection; the recommended pediatric dosage ranges from 2 to 6 mg/kg as a single IM injection not to exceed 100 mg. Intravenous Administration Pentobarbital Sodium should not be admixed with any other medication or solution. IV injection is restricted to conditions in which other routes are not feasible, either because the patient is unconscious (as in cerebral hemorrhage, eclampsia, or status epilepticus), or because the patient resists (as in delirium), or because prompt action is imperative. Slow IV injection is essential, and patients should be carefully observed during administration. This requires that blood pressure, respiration, and cardiac function be maintained, vital signs be recorded, and equipment for resuscitation and artificial ventilation be available. The rate of IV injection should not exceed 50 mg/min for Pentobarbital Sodium.

Habit forming: Barbiturates may be habit forming. Tolerance, psychological and physical dependence may occur with continued use. (See " Drug Abuse and Dependence " and " Pharmacokinetics " sections). Patients who have psychological dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. To minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in the dependent person may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive dosage over long periods of time. (See " Drug Abuse and Dependence " section). IV administration: Too rapid administration may cause respiratory depression, apnea, laryngospasm, or vasodilation with fall in blood pressure. Acute or chronic pain: Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked. However, the use of barbiturates as sedatives in the postoperative surgical period and as adjuncts to cancer chemotherapy is well established. Use in pregnancy: Barbiturates can cause fetal damage when administered to a pregnant woman.

The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients. Because such patients may be less aware of certain of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients. More than 1 in 100 patients. The most common adverse reaction estimated to occur at a rate of 1 to 3 patients per 100 is: Nervous System: Somnolence. Less than 1 in 100 patients. Adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are: Nervous system: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality. Respiratory system: Hypoventilation, apnea. Cardiovascular system: Bradycardia, hypotension, syncope. Digestive system: Nausea, vomiting, constipation. Other reported reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Pregnancy Teratogenic effects. See " Warnings - Use in Pregnancy " section Nonteratogenic effects. Reports of infants suffering from long-term barbiturate exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days. (See " Drug Abuse and Dependence " section). Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans. In a published study, administration of an anesthetic dose of ketamine for 24 hours on Gestation Day 122 increased neuronal apoptosis in the developing brain of the fetus. In other published studies, administration of either isoflurane or propofol for 5 hours on Gestation Day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. With respect to brain development, this time period corresponds to the third trimester of gestation in the human.

The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and with various neurological disorders. Acute overdosage with barbiturates is manifested by CNS and respiratory depression which may progress to Cheyne-Stokes respiration, areflexia, constriction of the pupils to a slight degree (though in severe poisoning they may show paralytic dilation), oliguria, tachycardia, hypotension, lowered body temperature, and coma. Typical shock syndrome (apnea, circulatory collapse, respiratory arrest, and death) may occur. In extreme overdose, all electrical activity in the brain may cease, in which case a "flat" EEG normally equated with clinical death cannot be accepted. This effect is fully reversible unless hypoxic damage occurs. Consideration should be given to the possibility of barbiturate intoxication even in situations that appear to involve trauma.

• May 23, 2016ANDAANDA206404Sagent Pharms Inc
• Nov 13, 2017ANDAANDA203619Hikma

1. 1Oxygen Saturation Decreased4751%
2. 2Procedural Complication1415%
3. 3Aspiration1314%
4. 4Cardiac Arrest1011%
5. 5Haemodynamic Instability1011%
6. 6Toxicity To Various Agents77.6%
7. 7Completed Suicide55.4%
8. 8Hypotension44.3%
9. 9Drug Ineffective33.3%
10. 10Drug Resistance33.3%
11. 11Seizure33.3%
12. 12Status Epilepticus33.3%
13. 13Cardio-respiratory Arrest22.2%
14. 14Death22.2%
15. 15Intentional Product Misuse22.2%

Recent PubMed references pinned to Pentobarbital as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• On an alleged case of euthanasia by pentobarbital administration.
  Legal medicine (Tokyo, Japan) · 2026 · Basilicata P, Simonelli A, Marisei M, et al.
  PMID 42134277DOI 10.1016/j.legalmed.2026.102857
• Population Pharmacokinetics and Dosing Simulations of Pentobarbital in the Pediatric Population.
  Journal of clinical pharmacology · 2026 · Helfer VE, Medina-Aymerich L, Muller WJ, et al.
  PMID 42087498DOI 10.1002/jcph.70204
• Solid-State Stability of Pentobarbital in Fast-Dissolving Suppositories: Implications for Dissolution Behavior and Pediatric Formulation Performance.
  Pharmaceutical research · 2026 · Freisz A, Dhifallah I, Chennell P, et al.
  PMID 41776151DOI 10.1007/s11095-026-04059-7
• Accidental secondary pentobarbital intoxication in small domestic animals and wild birds in Europe.
  Tierarztliche Praxis. Ausgabe K, Kleintiere/Heimtiere · 2026 · Neubert A, Schnurr A, Ammer H, et al.
  PMID 41688128DOI 10.1055/a-2768-0972
• Pentobarbital suppresses breast cancer proliferation by downregulating proliferating cell nuclear antigen.
  Journal of physiology and pharmacology : an official journal of the Polish Physiological Society · 2025 · Teng XQ, Sun YQ, Liu XR, et al.
  PMID 41335533DOI 10.26402/jpp.2025.4.05
• Sleep-promoting effects and mechanisms of Bacillus coagulans IDCC 1201: evidence from pentobarbital-induced sleep and electroencephalography analysis in mice.
  Food & function · 2025 · Kim H, Bang WY, Kim D, et al.
  PMID 41258765DOI 10.1039/d5fo02926k
• Sevoflurane, as opposed to pentobarbital anesthesia, attenuates LPS-induced myocardial injury by up-regulating TAF1D.
  Scientific reports · 2025 · Liu Z, Liu Q, Zhao Y, et al.
  PMID 41125865DOI 10.1038/s41598-025-20890-1
• Is the categorical denial of pentobarbital for assisted suicide a violation of the constitutional right to a self-determined death in Germany?
  Medical law review · 2025 · Braun K
  PMID 40971488DOI 10.1093/medlaw/fwaf033

The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Pentobarbital as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Induction Agents in ECT: Effects on Seizure Duration, Quality, and Recovery
  Completed · Interventional · 100 enrolled · Dr. Lutfi Kirdar Kartal Training and Research Hospital
  NCT07596095updated 2026-05-19
• Differential SERCA Expression in Laryngeal Muscles
  Completed · Interventional · 40 enrolled · Sohag University
  NCT06837467updated 2025-02-20
• Investigational and Comparative Study in the Management of Diabetic Nephropathy
  Completed · Phase 3 · Interventional · 90 enrolled · Tanta University
  NCT05487755updated 2024-05-14
• Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
  Completed · Observational · 3,520 enrolled · Daniel Benjamin
  NCT01431326updated 2023-09-06
• Comparison of Chlorpromazine or Pentobarbital Premedications for Pediatric Imaging Procedures
  Unknown · Observational · 254 enrolled · University Hospital, Brest
  NCT04350528updated 2020-04-17
• A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
  Completed · Phase 1 · Interventional · 280 enrolled · Children's Hospital Medical Center, Cincinnati
  NCT02250820updated 2020-01-21
• Comparing Safety and Efficacy of Dexmedetomidine and Propofol
  Terminated · Phase 3 · Interventional · 15 enrolled · Boston Children's Hospital
  NCT01152021updated 2019-05-21
• Dexmedetomidine Versus Pentobarbital for Pediatric Procedural Sedation
  Withdrawn · Interventional · 0 enrolled · Washington University School of Medicine
  NCT00878345updated 2018-06-28
• GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1
  Withdrawn · Phase 1 · Phase 2 · Interventional · 0 enrolled · University of California, Los Angeles
  NCT00123578updated 2016-05-12
• Pharmacokinetics and Pharmacodynamics of Pentobarbital in Neonates, Infants, and Children Following Open Heart Surgery
  Terminated · Observational · 37 enrolled · Children's Hospital of Philadelphia
  NCT00577434updated 2015-03-12

Frequently asked questions

How does Pentobarbital work?

Mechanism-of-action class: Neurotransmitter Transporter Interactions.

What is Pentobarbital used for?

According to FDA labeling, Pentobarbital carries indications including: Parenteral Sedatives. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See " Clinical Pharmacology " section).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pentobarbital?

Pentobarbital is classified as Barbiturates, plain, Neurotransmitter Transporter Interactions, Decreased Organized Electrical Activity, General Anesthesia.

What are the brand names for Pentobarbital?

Pentobarbital is marketed under brand names including Euthaphen, Euthasol, Fatal-Plus, Nembutal, Pentobarsol.

What are the contraindications for Pentobarbital?

Pentobarbital labeling lists contraindications including: Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria.. Always consult the full prescribing information and a clinician.