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Midazolam (sold under the brand name Versed®) is a fast-acting benzodiazepine approved for various medical uses in the United States. It is classified as a controlled substance in the U.S. due to its potential for misuse and dependence. Access to midazolam must be obtained by prescription under federal law.
- Midazolam is classified as a Schedule IV controlled substance approved for a range of medical uses, and it is a tightly regulated substance under U.S. law.
- Midazolam can only be obtained with a valid prescription. It cannot be legally purchased over the counter.
- Obtaining benzodiazepines without a prescription violates federal law and carries significant health risks. Illicit benzodiazepines may contain unknown doses or harmful adulterants, raising the risk of overdose.
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Midazolam schedule substance status
Under the U.S Controlled Substances Act (CSA), midazolam is a Schedule IV substance. [1] Schedule IV drugs have accepted medical uses but still pose a risk of abuse and dependence, albeit less than some other controlled substances. Therefore, Versed® can be prescribed under certain regulations, unlike Schedule I substances (like heroin), which are prohibited entirely.
Common Schedule IV drugs include other benzodiazepines, like alprazolam (Xanax) and diazepam (Valium), plus tramadol (Ultram), which is an opioid medicine used for the short-term relief of moderate to severe pain.
Who can prescribe midazolam?
Midazolam can only be prescribed or administered by qualified healthcare professionals who hold a federal DEA registration for prescribing controlled substances. This includes licensed physicians, nurse practitioners, physician assistants, and (in some cases) dentists, for situations when procedural sedation is clinically indicated. [2] However, the prescribing regulations for nurse practitioners and physician assistants vary by state law.
In practice, Versed® is most commonly ordered by anesthesiologists or emergency medicine physicians to sedate patients before surgery, during procedures, or in intensive care settings. Like all benzodiazepines, midazolam is legally available only by prescription under U.S. federal law. [2]
In addition, prescribers must follow federal and state controlled substance prescribing regulations (like using official prescription forms or electronic prescribing), and they typically include their DEA registration number on the prescription.
Is it available over the counter?
Midazolam is not available over the counter, as it cannot be purchased without a prescription from a licensed healthcare provider. The DEA’s guidance is clear: Benzodiazepines are only legally available through a prescription from a licensed healthcare practitioner. [1] This means pharmacies will not and are not allowed to sell midazolam (or any benzodiazepine) without a signed prescription from a medical professional.
The risks of illegal benzodiazepines
Getting benzodiazepines (like midazolam) without a prescription, whether through doctor shopping or buying pills on the street, is illegal and dangerous. Under U.S. law (21 U.S.C. § 843(a)(3)), obtaining controlled substances through deception can lead to fines or imprisonment. [3]
Distributing or possessing benzodiazepines with the intent to distribute them is a separate federal crime under 21 U.S.C. § 841(a)(1), carrying more severe penalties, including felony charges and longer prison terms. [4]
Illicit benzodiazepines often contain harmful adulterants, such as fentanyl, xylazine, or unregulated designer drugs, like flualprazolam. These dangerous combinations increase the risk of overdose, respiratory depression, or death. [5][6][7]
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