# Desbutal

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**Desbutal** was the brand name of a [fixed-dose combination](/source/Fixed-dose_combination) formulation composed of 5mg of the [central nervous system (CNS)](/source/Central_nervous_system) [stimulant](/source/Stimulant) ("upper") [amphetamine derivative](/source/Amphetamine_derivative), [methamphetamine](/source/Methamphetamine) [hydrochloride (HCl)](/source/Hydrochloride_salt) and 30 mg of the [CNS depressant](/source/CNS_depressant) ("downer") [barbiturate](/source/Barbiturate), [pentobarbital sodium](/source/Pentobarbital). Manufactured by [Abbott Laboratories](/source/Abbott_Laboratories) as a [scored tablet](/source/Tablet_(pharmacy)) [to be taken orally](/source/Oral_medicine).

[Marketed](/source/Pharmaceutical_marketing) as an [antidepressant](/source/Antidepressant), as well an [anorectic](/source/Anorectic) for treating [obesity](/source/Obesity), a treatment for [narcolepsy](/source/Narcolepsy), [parkinsonism](/source/Parkinsonism), [alcoholism](/source/Alcoholism), and some [off-label uses](/source/Off-label_use), Desbutal had a high potential for abuse and dependence, consequently being discontinued.[1]

## Dosage forms

Desbutal was designed as round biphasic tablets, with the two [active ingredients](/source/Active_ingredient) visibly partitioned between the two faces of the tablet to control their rates of dissolution and achieve a more preferable [pharmacokinetic](/source/Pharmacokinetic) profile. Each tablet featured a yellow half which contained an immediate-release formulation of pentobarbital sodium, and a blue half which contained a [sustained-release](/source/Modified-release_dosage#Sustained-release_dosage_forms) formulation of methamphetamine hydrochloride (Desoxyn Gradumet). The three [dosages](/source/Dosage_form) of tablets that were manufactured included 5 mg, 10 mg, and 15 mg of methamphetamine hydrochloride with 30 mg, 60 mg, and 90 mg of pentobarbital sodium, respectively. [Abuse](/source/Substance_abuse) of Desbutal often involved physical separation of these two halves by sawing with a razor or fingernails, followed by the consumption of each active ingredient independently rather than concurrently. Typically abusers would ingest the blue half containing methamphetamine for stimulation and [wakefulness](/source/Eugeroic), followed by future ingestion of the yellow half containing pentobarbital as a [hypnotic](/source/Hypnotic) for counteracting stimulant-induced [insomnia](/source/Insomnia) whenever sleep was desired.

## Overdose

Desbutal [overdose](/source/Drug_overdose) was typically life-threatening as a result of [acute toxicity](/source/Acute_toxicity) from pentobarbital poisoning, since the [oral](/source/Oral_administration) [median lethal dose (LD50)](/source/Median_lethal_dose) of pentobarbital sodium is reached significantly sooner than the oral LD50 of methamphetamine hydrochloride when consumed as [dosage units](/source/Dose_(biochemistry)) with the mass ratio present in Desbutal. [Barbiturate overdose](/source/Barbiturate_overdose) is a [medical emergency](/source/Medical_emergency) which was treated with immediate [gastric lavage](/source/Gastric_lavage), [mechanical ventilation](/source/Mechanical_ventilation), and intermittent [intravenous](/source/Intravenous_therapy) [bolus](/source/Bolus_(medicine)) administration of multiple different drugs, since no [selective](/source/Binding_selectivity) barbiturate [binding site](/source/Binding_site) [receptor antagonists](/source/Receptor_antagonist) were clinically available as an [antidote](/source/Antidote), and dosages were dependent on individual patient response. These drugs often included [picrotoxin](/source/Picrotoxin), [amiphenazole](/source/Amiphenazole) (Daptazile), [bemegride](/source/Bemegride) (Megimide), and [methamphetamine sulfate](/source/Methamphetamine) (Methedrine) in dosages sometimes exceeding 250 mg over the first 24-hour period of being admitted into an [intensive care unit](/source/Intensive_care_unit) (ICU). While a quantitative relationship between the blood levels of barbiturate derivatives and the depression of the [central nervous system](/source/Central_nervous_system) (CNS) had become established by researchers in 1955, they also emphasized that the accurate correlation of these factors is complicated by the presence of [tolerance](/source/Drug_tolerance) to the drug, intercurrent disease and [senility](/source/Dementia#Terminology), as well as the [concurrent administration](/source/Drug_interaction) of other [noxious substances](/source/Poison).

## Regulations

[Marketing approval](/source/New_drug_application) of Desbutal was withdrawn by the [United States Food and Drug Administration](/source/United_States_Food_and_Drug_Administration) (FDA) in 1973 as part of a mass [drug recall](/source/Drug_recall) of all [anorectic](/source/Anorectic) [combination drugs](/source/Combination_drug) containing a [CNS stimulant](/source/Stimulant) paired with a [CNS depressant](/source/Depressant).[2] The recall also included all existing stocks of [parenteral](/source/Parenteral) amphetamines based on the FDA's contention that these products have such a great drug abuse potential that they cannot be used safely.

Despite the [Bureau of Narcotics and Dangerous Drugs](/source/Bureau_of_Narcotics_and_Dangerous_Drugs) having already reduced the amphetamine aggregate production quota for pharmaceutical manufacturers by approximately 90% in the previous two years, these combination drugs had rapidly grown in popularity throughout the prior two decades. Many pharmaceutical manufacturers were vigorously competing for market share by continuously developing new combinations and [dosage formulations](/source/Pharmaceutical_formulation), and at the time of the 1973 recall, the estimated annual distribution of these pills was equivalent to 480 million dosage units of [Obetrol](/source/Obetrol) 10 mg tablets.[citation needed]

### Medical use of discontinued combination drugs

Discontinued psychiatric combination drugs were often justified for medical use through the lens of a multifaceted, comprehensive approach to health care treatment. CNS stimulants (colloquially called "uppers") were used variously for their [appetite-suppressing](/source/Anorectic), [antidepressant](/source/Antidepressant), and [wakefulness-promoting](/source/Eugeroic) properties, in addition to providing alertness, energy and motivation, as well as sustained focus, while a CNS [depressant](/source/Depressant) (typically a [barbiturate](/source/Barbiturate) or similar [sedative-hypnotic](/source/Sedative-hypnotic) agent) would mitigate the stimulant's adverse effects without eliminating therapeutic benefits. These medications could also replace [monoamine oxidase inhibitors](/source/Monoamine_oxidase_inhibitors) in the treatment of patients with certain forms of [refractory depression](/source/Refractory_depression) where MAOIs are indicated, but the patient would be unlikely to restrict [tyramine](/source/Tyramine) from the diet.

Typically, the CNS stimulant within these older, now-defunct combination drugs was racemic amphetamine, dextroamphetamine, or methamphetamine as various single or mixed salts, although [substituted amphetamine](/source/Substituted_amphetamine) [anorectic](/source/Anorectic) stimulants ("diet pills") like [phenmetrazine](/source/Phenmetrazine), [phendimetrazine](/source/Phendimetrazine), and [phentermine](/source/Phentermine) were occasionally used [marketed](/source/Pharmaceutical_marketing).

Likewise, the CNS depressant within the historical combination drugs was typically a single barbiturate salt, often [pentobarbital](/source/Pentobarbital) sodium or [amobarbital](/source/Amobarbital), but non-barbiturate tranquilizers such as [meprobamate](/source/Meprobamate) (*Miltown*) and sedatives like [methaqualone](/source/Methaqualone) [hydrochloride](/source/Hydrochloride) would occasionally replace the barbiturate.

Less common formulations of combination drugs included a CNS stimulant paired with [multiple] [vitamins](/source/Vitamins) and minerals; a stimulant with a [typical antipsychotic](/source/Typical_antipsychotic) ([Eskatrol](/source/Eskatrol) is a primary example); or a stimulant and a [first generation antihistamine](/source/First_generation_antihistamine). There also existed formulations utilizing amphetamines paired with [phenacetin](/source/Phenacetin) and [aspirin](/source/Aspirin) for the purpose of [pain relief](/source/Analgesia), in addition to either a barbiturate or meprobamate.

## See also

- [Amfecloral](/source/Amfecloral), a single molecule with a similar effect (due to metabolites).
- [Dexamyl](/source/Dexamyl), another pharmaceutical containing an amphetamine and a barbiturate.
- [D-IX](/source/D-IX), an experimental drug containing methamphetamine, cocaine & oxycodone.
- [Speedball](/source/Speedball_(drug)), which is the same concept but using opioids instead of a barbiturate.
- [Tuinal](/source/Tuinal), an insomnia medication containing two different barbiturates.

## References

1. Kanable R. [""Speedballs" in a can"](https://www.proquest.com/docview/229774539). *Law Enforcement Technology*. **35** (6)

1. Schmeck Jr HM (2 April 1973). ["U.S. Sets Diet Drug Recall In Drive on Amphetamines"](https://www.nytimes.com/1973/04/02/archives/us-sets-diet-drug-recall-indrive-on-amphetamines-us-to-begin-diet.html). *The New York Times*

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Adapted from the Wikipedia article [Desbutal](https://en.wikipedia.org/wiki/Desbutal) by Wikipedia contributors ([contributor history](https://en.wikipedia.org/wiki/Desbutal?action=history)). Available under [Creative Commons Attribution-ShareAlike 4.0 International](https://creativecommons.org/licenses/by-sa/4.0/). Changes may have been made.