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Is diazepam a classified drug? Understanding Its Schedule IV Status

4 min read

In the United States, approximately 30.6 million adults report using benzodiazepines like diazepam [1.5.1]. The crucial question for patients and caregivers is, is diazepam a classified drug? Yes, it is federally regulated due to its potential for dependence and abuse [1.2.3].

Quick Summary

Diazepam, known by the brand name Valium, is a federally classified drug. It is designated as a Schedule IV controlled substance due to its recognized medical uses and its potential for abuse and dependence.

Key Points

  • Schedule IV Controlled Substance: Diazepam is classified as a Schedule IV drug under the U.S. Controlled Substances Act, indicating a recognized medical use but also a potential for abuse and dependence [1.2.1, 1.3.4].

  • Mechanism of Action: It belongs to the benzodiazepine class, working by enhancing the effect of the neurotransmitter GABA to calm brain activity [1.6.4].

  • Approved Medical Uses: Diazepam is FDA-approved to treat anxiety disorders, muscle spasms, seizures, and symptoms of alcohol withdrawal [1.6.1].

  • Risk of Dependence: Long-term use can lead to physical dependence, and abrupt cessation can cause significant withdrawal symptoms, including seizures [1.6.2, 1.10.3].

  • Strict Prescription Laws: As a Schedule IV drug, prescriptions for diazepam are limited to five refills within a six-month period, after which a new prescription is required [1.11.1].

  • Risk with Other Substances: Combining diazepam with alcohol or opioids greatly increases the risk of severe respiratory depression, coma, and death [1.6.2].

  • Long Half-Life: Diazepam has a long half-life, meaning it and its active metabolites remain in the body for an extended period, which can lead to accumulation [1.2.3, 1.9.3].

In This Article

What is Diazepam?

Diazepam is a prescription medication belonging to a class of drugs called benzodiazepines [1.2.3]. Commonly known by its brand name, Valium, it acts as a central nervous system (CNS) depressant, calming overactivity in the brain [1.6.2]. This pharmacological action makes it effective for various conditions. The FDA has approved diazepam for managing anxiety disorders, providing short-term relief from anxiety symptoms, treating muscle spasms, controlling certain types of seizures, and managing symptoms of alcohol withdrawal [1.6.1, 1.6.3]. It works by enhancing the effects of a neurotransmitter called gamma-aminobutyric acid (GABA), which produces a calming effect on the brain [1.6.4].

Is Diazepam a Classified Drug? The Controlled Substances Act

Yes, diazepam is a classified, or controlled, substance in the United States [1.2.3]. This regulation falls under the Controlled Substances Act (CSA), which was established to regulate drugs with a potential for abuse and dependence [1.4.4]. The U.S. Drug Enforcement Administration (DEA) categorizes these drugs into five schedules, from Schedule I (highest potential for abuse, no accepted medical use) to Schedule V (lowest potential for abuse) [1.4.5].

Diazepam's Classification: A Schedule IV Drug

Diazepam is specifically classified as a Schedule IV controlled substance [1.2.1, 1.3.4]. This category includes drugs that have:

  • A low potential for abuse relative to substances in Schedule III [1.4.1].
  • A currently accepted medical use in treatment in the United States [1.4.1].
  • Abuse may lead to limited physical dependence or psychological dependence relative to the drugs in Schedule III [1.4.1].

Other medications in Schedule IV include alprazolam (Xanax), clonazepam (Klonopin), and zolpidem (Ambien) [1.2.1, 1.4.5]. This classification signifies that while diazepam is a valuable medical tool, it carries risks that necessitate government oversight [1.2.2].

Why is Diazepam Controlled?

The primary reasons for classifying diazepam as a controlled substance are its potential for abuse, misuse, and the risk of physical and psychological dependence [1.2.3, 1.9.1].

Potential for Abuse and Misuse

Abuse of benzodiazepines like diazepam can involve taking higher doses than prescribed, using the medication for non-medical reasons (like getting high), or taking it with other substances such as alcohol or opioids [1.2.3]. Combining diazepam with other CNS depressants dramatically increases the risk of severe side effects, including life-threatening respiratory depression, sedation, and coma [1.6.2].

Dependence and Withdrawal

With prolonged use (even for just a few weeks), a person can develop a physical dependence on diazepam [1.6.2]. This means the body adapts to the drug's presence and will experience withdrawal symptoms if the medication is stopped abruptly or the dose is significantly reduced [1.6.2].

Withdrawal symptoms can be distressing and sometimes dangerous. They may include [1.10.1, 1.10.3]:

  • Anxiety and panic attacks
  • Insomnia
  • Irritability
  • Headaches
  • Muscle pain and cramps
  • Tremors
  • In severe cases, seizures and hallucinations

Due to these risks, medical supervision is essential when discontinuing diazepam after long-term use. A doctor will typically implement a gradual tapering schedule to minimize withdrawal symptoms [1.6.2, 1.10.3].

Diazepam vs. Other Common Benzodiazepines

While all benzodiazepines are Schedule IV drugs, they have different properties, such as onset of action and half-life, which influences their use and risk profile.

Feature Diazepam (Valium) Alprazolam (Xanax) Lorazepam (Ativan)
Half-Life Long-acting (Metabolites can have a half-life of up to 200 hours) [1.2.3] Short-acting (Half-life of about 11 hours) [1.8.4] Intermediate-acting (Half-life of about 10-20 hours) [1.8.4]
Primary Uses Anxiety, muscle spasms, seizures, alcohol withdrawal [1.6.1] Anxiety, panic disorders [1.8.1] Anxiety, pre-anesthetic, alcohol withdrawal [1.8.2, 1.6.1]
Onset of Action Fast onset (Oral: 15-60 min; IV: 1-3 min) [1.6.1] Fast onset [1.8.4] Intermediate onset [1.8.4]
Classification Schedule IV [1.2.1] Schedule IV [1.2.1] Schedule IV [1.2.1]

Diazepam's long half-life means it stays in the body longer, which can be beneficial for managing continuous conditions like alcohol withdrawal but can also lead to accumulation, especially in older adults [1.9.3, 1.9.1].

Legal and Medical Implications of a Schedule IV Status

The Schedule IV classification carries specific legal requirements for both prescribers and patients [1.11.1].

  • Prescription Required: Diazepam can only be obtained with a valid prescription from a licensed practitioner [1.11.1].
  • Refill Limits: Federal law limits refills for Schedule III and IV substances. A prescription for diazepam cannot be refilled more than five times within a six-month period from the date it was issued [1.11.1, 1.11.2]. After five refills or six months, whichever comes first, a new prescription is required.
  • Monitoring: Healthcare providers are urged to prescribe diazepam for the shortest effective duration and to regularly assess the patient's risk for abuse, misuse, and addiction [1.7.4]. The FDA has not confirmed the safety of Valium use for more than four months in clinical studies [1.9.3].

Conclusion

To answer the question, is diazepam a classified drug?—the answer is an unequivocal yes. The U.S. DEA classifies diazepam as a Schedule IV controlled substance due to its potential for abuse and dependence, despite its significant medical benefits [1.2.1, 1.2.4]. This classification imposes strict regulations on its prescription and use to mitigate risks while allowing patients to access it for legitimate medical needs [1.11.1]. Patients prescribed diazepam should use it exactly as directed, be aware of its potential risks, and maintain open communication with their healthcare provider, especially regarding long-term use and discontinuation.


For anyone struggling with diazepam misuse or addiction, help is available. The Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline provides free, confidential, 24/7 treatment referral and information services. For more information, you can visit the SAMHSA website.

Frequently Asked Questions

Yes, diazepam is the generic name for the medication, while Valium is one of its most common brand names [1.2.1, 1.6.2].

Diazepam is a controlled substance because it has a potential for abuse, misuse, and can lead to physical and psychological dependence, especially with long-term use [1.2.3, 1.9.1].

Diazepam is classified as a Schedule IV controlled substance by the DEA [1.2.1, 1.3.4]. This means it has a lower potential for abuse than Schedule I, II, or III drugs but still presents a risk [1.4.1].

Under federal law, a prescription for a Schedule IV drug like diazepam can be refilled a maximum of five times within six months of the date the prescription was issued [1.11.1].

No, stopping diazepam suddenly after prolonged use is not safe and can lead to severe withdrawal symptoms, including anxiety, tremors, and potentially life-threatening seizures. Always consult a doctor to create a safe tapering plan [1.6.2, 1.10.3].

No, you should not drink alcohol while taking diazepam. Both are central nervous system depressants, and combining them significantly increases the risk of severe drowsiness, breathing problems, coma, and death [1.6.2, 1.9.4].

Both are Schedule IV benzodiazepines used for anxiety. The main difference is their half-life; diazepam is long-acting, staying in the system longer, while alprazolam is short-acting. This affects how often they are dosed and their potential for certain side effects [1.2.3, 1.8.1].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.