What Are Examples of Level 5 Drugs? Understanding DEA Schedule V Controlled Substances

October 9, 2025 •

4 min read

The U.S. Drug Enforcement Administration (DEA) classifies Schedule V substances as having the lowest potential for abuse among all controlled substances. Knowing what are examples of level 5 drugs is crucial for understanding their medical applications, legal standing, and regulatory differences compared to other drug schedules.

Quick Summary

DEA Schedule V drugs are controlled substances with the lowest abuse potential, used for various medical purposes. Examples include certain cough medicines with codeine, antidiarrheals like Lomotil, and the nerve pain drug Lyrica.

Key Points

Low Abuse Potential: Schedule V drugs are defined by the DEA as having the lowest potential for abuse and dependence compared to other controlled substances.
Common Examples: A key example of level 5 drugs includes cough preparations with a limited amount of codeine, such as Robitussin AC.
Therapeutic Uses: Schedule V substances are used for a variety of medical purposes, including relieving coughs, treating diarrhea, and managing nerve-related pain.
Nerve Pain Medications: The nerve pain medication Pregabalin, commonly known as Lyrica, is another example of a Schedule V drug.
Less Stringent Regulations: Due to their low abuse risk, Schedule V drugs have fewer prescription restrictions compared to higher-schedule drugs, though they still require medical oversight.
Antidiarrheal Drugs: Certain antidiarrheal medications, like Lomotil and Motofen, are also classified as Schedule V drugs due to their limited narcotic content.

What Defines a Schedule V Controlled Substance?

The federal Controlled Substances Act (CSA) established a five-tiered system for classifying drugs, chemicals, and other substances based on their potential for abuse and accepted medical use. Schedule V represents the least restrictive category among the controlled substances, indicating a low potential for abuse relative to Schedule IV drugs. The DEA and FDA review scientific evidence to place substances on these schedules.

For a drug to be classified as a Schedule V controlled substance, it must meet three specific criteria:

Low Potential for Abuse: The drug has a lower abuse potential compared to substances in Schedule IV.
Accepted Medical Use: It has a currently accepted medical use in the United States.
Limited Dependence: Abuse of the drug may lead to limited physical dependence or psychological dependence relative to Schedule IV substances.

Because of their lower abuse risk, Schedule V drugs are subject to less stringent regulations than higher-schedule drugs, though they still require medical oversight. These preparations often contain small quantities of narcotic and non-narcotic active ingredients, which is the primary reason for their inclusion in the controlled substance list.

Specific Examples of Level 5 Drugs

Numerous medications fall under the Schedule V classification, and many are quite common, though not always recognized as controlled substances by the general public.

Low-Dose Codeine Cough Preparations

Perhaps the most widely known examples of level 5 drugs are certain prescription cough medicines containing a limited amount of codeine. The DEA specifies that these preparations must contain no more than 200 milligrams of codeine per 100 milliliters or 100 grams.

Robitussin AC: A cough syrup that combines guaifenesin (an expectorant) with a small amount of codeine (an opioid cough suppressant).
Phenergan with Codeine: A combination product containing promethazine (an antihistamine) and codeine, used to treat cough and cold symptoms.

It's important to note that higher concentrations of codeine or products with other opioids will be classified in a higher schedule. The Food and Drug Administration (FDA) has also required labeling changes to restrict these products to adults 18 and older due to potential risks in children.

Antidiarrheal Medications

Certain preparations used to treat diarrhea are also Schedule V drugs because they contain a limited amount of narcotic-like ingredients to slow intestinal movement.

Lomotil: A combination medication containing diphenoxylate (an opioid agonist) and atropine, which is used to treat severe diarrhea. The atropine is included to discourage abuse.
Motofen: Similar to Lomotil, this medication also contains diphenoxylate and atropine for the treatment of diarrhea.

Other Analgesic and Anticonvulsant Drugs

Other therapeutic medications with a low abuse potential are also designated as Schedule V substances. This includes drugs used for nerve pain or seizures.

Pregabalin (Lyrica): Prescribed for nerve pain associated with conditions like diabetes, shingles, and fibromyalgia, as well as for partial-onset seizures. While its potential for abuse is low, it can cause limited dependence.
Ezogabine: An anticonvulsant medication used to treat seizures. It is also listed as a Schedule V controlled substance.
Brivaracetam (Briviact): An anti-epileptic drug used to treat seizures.

Regulations for Schedule V Substances

Federal regulations for Schedule V controlled substances are more lenient than for other schedules. While they typically require a prescription, refills are often authorized by the prescriber without the strict limitations placed on higher-schedule drugs. Pharmacists are also responsible for verifying that prescriptions are issued for a legitimate medical purpose. State and local laws can impose additional requirements, such as restricting over-the-counter availability of certain Schedule V products.

Comparison of Controlled Substance Schedules

Understanding where Schedule V fits within the broader DEA classification system is key to grasping its regulatory context. The table below compares the core characteristics of Schedule V with other schedules.


Feature	Schedule I	Schedule II	Schedule IV	Schedule V
Accepted Medical Use	No	Yes	Yes	Yes
Abuse Potential	High	High	Low	Lowest
Dependence Risk	Severe physical/psychological	Severe physical/psychological	Limited physical/psychological	Limited physical/psychological
Refills	Not applicable	No refills allowed without new prescription	Up to 5 refills within 6 months	As authorized by prescriber
Examples	Heroin, LSD	OxyContin, Methadone	Xanax, Ambien	Lyrica, Lomotil

Conclusion

What are examples of level 5 drugs? They are an important class of controlled substances, comprising medications with accepted medical uses and the lowest potential for abuse. These include common preparations for coughs, diarrhea, and nerve pain, such as low-dose codeine cough syrups, Lomotil, and Lyrica. While they are less restrictive than other controlled substances, their use is still regulated to prevent limited dependence or misuse. Patients should always use these medications exactly as prescribed by a healthcare provider to ensure safety and effectiveness.

For additional information, the DEA provides a detailed alphabetical listing of all controlled substances on its website.

Frequently Asked Questions

The primary difference lies in their relative potential for abuse. Schedule V drugs have a lower potential for abuse and a more limited risk of dependence compared to Schedule IV drugs, though both are considered to have a low risk.

No. Only cough preparations with very specific, limited quantities of codeine fall under Schedule V. Higher concentrations of codeine are classified in a higher schedule with stricter regulations.

Lyrica is classified as a Schedule V controlled substance because, while its abuse potential is low, it can still lead to limited physical or psychological dependence if misused. It is used to treat nerve pain and seizures.

Some Schedule V medications, particularly certain cough syrups, may be available over-the-counter in some states, though they are still closely monitored. However, most require a prescription due to federal or state regulations.

Although the abuse and dependence potential is low, misusing a Schedule V drug can still lead to limited physical or psychological dependence. Federal and state laws also impose penalties for illegal possession or distribution.

Lomotil, which contains diphenoxylate and atropine, is an antidiarrheal medication. It is a Schedule V controlled substance because the diphenoxylate has opioid-like effects that slow intestinal movement.

Yes, refills are typically allowed for Schedule V medications, but they must be authorized by the prescribing practitioner. This is different from Schedule II drugs, which require a new prescription each time.