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Last Updated: March 18, 2025

CLINICAL TRIALS PROFILE FOR SODIUM BUTABARBITAL


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All Clinical Trials for SODIUM BUTABARBITAL

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Fundação de Amparo à Pesquisa do Estado de São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗ Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil Completed Federal University of São Paulo Phase 4 2014-08-01 The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for SODIUM BUTABARBITAL

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Atrial Fibrillation[disabled in preview]
Condition Name for SODIUM BUTABARBITAL
Intervention Trials
Atrial Fibrillation 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Atrial Fibrillation[disabled in preview]
Condition MeSH for SODIUM BUTABARBITAL
Intervention Trials
Atrial Fibrillation 1
[disabled in preview] 0
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Clinical Trial Locations for SODIUM BUTABARBITAL

Trials by Country

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Trials by Country for SODIUM BUTABARBITAL
Location Trials
Brazil 1
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Clinical Trial Progress for SODIUM BUTABARBITAL

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4[disabled in preview]
Clinical Trial Phase for SODIUM BUTABARBITAL
Clinical Trial Phase Trials
Phase 4 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Completed[disabled in preview]
Clinical Trial Status for SODIUM BUTABARBITAL
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for SODIUM BUTABARBITAL

Sponsor Name

trials000001111111Fundação de Amparo à Pesquisa do Estado de São PauloFederal University of São Paulo[disabled in preview]
Sponsor Name for SODIUM BUTABARBITAL
Sponsor Trials
Fundação de Amparo à Pesquisa do Estado de São Paulo 1
Federal University of São Paulo 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Other[disabled in preview]
Sponsor Type for SODIUM BUTABARBITAL
Sponsor Trials
Other 2
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Sodium Butabarbital: Clinical Trials, Market Analysis, and Projections

Overview of Sodium Butabarbital

Sodium butabarbital, commonly known by its brand name Butisol, is a fast-acting barbiturate with a short duration of action. It is used primarily as a sedative or hypnotic to treat anxiety and insomnia.

Clinical Use and Indications

  • Sedation and Hypnosis: Sodium butabarbital is indicated for the short-term treatment of insomnia and for routine sedation. It is particularly useful for pre-operative anxiety and sedation[1][2][5].
  • Duration of Action: Unlike other barbiturates, sodium butabarbital has a shorter duration of action, typically lasting around 6-8 hours. This makes it suitable for short-term use[1][2].

Mechanism of Action

  • GABA-A Receptor Modulation: Sodium butabarbital acts as a positive allosteric modulator of GABA-A receptors, enhancing the inhibitory effects of gamma-aminobutyric acid (GABA) in the brain. This action leads to sedation and reduced anxiety[1].
  • Neurotransmitter Inhibition: It also inhibits neuronal acetylcholine and glutamate receptors, further contributing to its sedative effects[1].

Pharmacokinetics

  • Absorption: Sodium butabarbital is rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations achieved within 3-4 hours after oral administration[2].
  • Distribution: It is distributed to all tissues and fluids, with high concentrations in the brain, liver, and kidneys. The drug is bound to plasma and tissue proteins[2].
  • Elimination: The elimination half-life of sodium butabarbital is reported to be between 34-42 hours, though one manufacturer states it can average up to 100 hours in adults[2].

Clinical Trials

As of the latest available data, there are no ongoing or recent clinical trials specifically focused on sodium butabarbital. The drug has been well-established since its FDA approval on June 5, 1939, and most of its clinical trials were conducted in the early stages of its development[5].

Market Analysis

Current Market Size and Trends

  • Global Barbiturate Market: The global barbiturate drugs market, which includes sodium butabarbital, was valued at USD 483 million in 2023. Despite a decline in 2020 due to the COVID-19 pandemic, the market is expected to grow at a CAGR of 3.12% from 2024 to 2030[3].
  • Factors Driving Growth: The rising prevalence of conditions such as insomnia, epilepsy, and anxiety, along with an increasing geriatric population, are key factors driving the growth of the barbiturate market[3].

Market Challenges

  • Pandemic Impact: The COVID-19 pandemic disrupted healthcare services and global supply chains, affecting the availability of barbiturate medications. This disruption had a negative impact on the market in 2020[3].
  • Competition from Benzodiazepines: Sodium butabarbital is less commonly used in recent years due to the preference for benzodiazepines, which are often prescribed for similar indications[5].

Market Projections

Future Growth

  • Increasing Demand: The market is expected to experience growth due to the increasing prevalence of neurological disorders such as epilepsy and insomnia. According to the World Health Organization, epilepsy affects approximately 50 million individuals worldwide, with varying diagnosis rates across different regions[3].
  • Geriatric Population: The growing geriatric population is another significant factor contributing to the projected growth of the barbiturate market, as older adults are more likely to suffer from conditions that require sedative or hypnotic medications[3].

Potential Risks and Opportunities

  • Abuse Potential: Sodium butabarbital has a high abuse potential due to its short duration of action, which is comparable to other barbiturates like secobarbital. This could lead to regulatory scrutiny and affect market dynamics[5].
  • Innovation and Alternatives: The development of newer, safer alternatives to barbiturates could pose a risk to the market. However, the established use and efficacy of sodium butabarbital may continue to support its place in the market[1][2].

Key Takeaways

  • Clinical Use: Sodium butabarbital is used for short-term treatment of insomnia and as a sedative.
  • Mechanism of Action: It modulates GABA-A receptors and inhibits other neurotransmitter receptors.
  • Pharmacokinetics: Rapid absorption, wide distribution, and a half-life of 34-42 hours.
  • Market Trends: The barbiturate market is growing due to increasing prevalence of neurological disorders and a growing geriatric population.
  • Challenges: Competition from benzodiazepines and potential for abuse.

FAQs

What is the primary use of sodium butabarbital?

Sodium butabarbital is primarily used as a sedative or hypnotic to treat anxiety and short-term insomnia.

How does sodium butabarbital work?

It works by modulating GABA-A receptors and inhibiting neuronal acetylcholine and glutamate receptors, leading to sedation.

What are the potential risks associated with sodium butabarbital?

It has a high abuse potential and can cause adverse effects such as worsening insomnia, drowsiness, falls, and complex behavior while not fully awake.

How long has sodium butabarbital been approved for use?

Sodium butabarbital was granted FDA approval on June 5, 1939.

What factors are driving the growth of the barbiturate market?

The rising prevalence of conditions like insomnia, epilepsy, and anxiety, along with an increasing geriatric population, are key factors driving the growth of the barbiturate market.

Sources

  1. DrugBank: Butabarbital: Uses, Interactions, Mechanism of Action.
  2. Pharmacompass: Butabarbital | Drug Information, Uses, Side Effects, Chemistry.
  3. Grandview Research: Barbiturate Drugs Market Size, Share & Growth Report, 2030.
  4. DrugBank: Butalbital: Uses, Interactions, Mechanism of Action.
  5. DrugBank: Butabarbital sodium.

More… ↓

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