Butalbital, which is sold under the brand names Fioricet and Esgic, is a prescription medication used to treat migraines, tension headaches, and chronic daily headache pain.
It has also been used in the past to relieve pain after surgery or injury and to help people sleep if they’re struggling with insomnia or other sleep disorders.
The Drug Enforcement Administration (DEA) classifies butalbital products as controlled substances due to their potential for misuse. However, Fioricet is considered an exempted prescription product.
Why Fioricet Is Not Considered A Controlled Substance
While Fioricet must be prescribed, it is not a federally controlled substance under the Controlled Substances Act (CSA).
Fioricet’s exemption status was granted in 1967 under the laws that preceded the Controlled Substances Act in 1970. Its status carried over to the drug schedules that were created at that time.
However, other prescriptions that contain butalbital, such as Fiorinal, are listed as Schedule III drugs.
Exempted products on the controlled substances list are those which contain an ingredient considered addictive or a risk for misuse but also contain other ingredients believed to negate the risk for addiction.
The reasons listed below describe why Fioricet is exempted from the Controlled Substance Schedules.
The dosages of butalbital, acetaminophen, and caffeine contained in a single tablet of Fioricet are 50 mg, 325 mg, and 40 mg, respectively.
A doctor or healthcare provider must write a Fioricet prescription for a person to obtain the medication, which helps to regulate its use.
Nevertheless the presence of acetaminophen in Fioricet, which is also the main ingredient in Tylenol, is believed to deter people from the abuse of the butalbital because of potential liver damage.
However, butalbital is addictive, which is why other prescriptions such as Fiorinal are listed in Schedule III, and can cause Fioricet dependence i.
Fioricet’s Potential Loss Of Exemption Status
According to the Federal Register, on April 12, 2022, the DEA proposed removing the exemption status of Fioricet and similar drugs that contain butalbital.
The DEA has found that in recent years, the presence of acetaminophen has not deterred people from abusing Fioricet.
The DEA has documented law enforcement encounters with the medication, exploitation of the exemption status, diversion, and online distribution for the purposes of abuse.
However, as of April 7, 2023, Fioricet was still on the Table of Exempted Prescription Products created by the DEA.
What Drug Class Is Fioricet?
All butalbital products, including Fioricet, are classified as barbiturates. Barbiturates produce their effects by acting on the central nervous system (CNS).
Fioricet with codeine belongs to a group of medications called analgesics or opioid combinations.
How Fioricet Works In The Body
Fioricet has three active ingredients, butalbital, acetaminophen, and caffeine, which work together to alleviate headaches and pain.
Acetaminophen and barbiturates are analgesics that alleviate pain, while barbiturates are also anti-anxiety agents.
Experts believe that butalbital works by relaxing muscle contractions and enhancing the inhibitory effects of Gama aminobutyric acid (GABA) when it is used to treat pain caused by tension headaches.
What States Control Fioricet?
While Fioricet enjoys exemption status on a federal level, some states have placed tight regulations on butalbital.
States that control Fioricet include:
- West Virginia
- New Mexico
- Rhode Island
Why Fioricet Is Controlled In Some States And Not Others
It comes down to a difference of opinion on the abuse potential of Fioricet. As mentioned above, it is currently the DEA’s conclusion that Fioricet has considerable abuse potential.
Some states seem to have come to that conclusion earlier than the DEA, which is why they put restrictions in place regarding Fioricet.
Effects Of Fioricet Abuse
Taking too much butalbital in a short period of time can lead to dangerous side effects.
Some of these side effects are fatal and include:
- respiratory depression
- heart failure
Other butalbital side effects include:
- gastrointestinal problems
People who abuse Fioricet may also experience liver damage, severe withdrawal symptoms, severe skin reactions, and overdose.
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- Federal Register
- U.S. Department of Justice
- U.S. Government Publishing Office: Drug Enforcement Agency