Key takeaways:
Tramadol (Ultram, ConZip) is an opioid medication that treats pain. It has been classified as a controlled substance since 2014.
Tramadol is a schedule IV controlled substance. It has a higher potential for dependence and addiction than non-controlled medications.
A tramadol prescription can be refilled a maximum of five times within 6 months. After 6 months or five refills, a new prescription is needed. But keep in mind this may vary from state to state.
Tramadol (ConZip) is an opioid pain medication that was FDA-approved in 1995. At first, tramadol was a non-controlled medication. This means it could be prescribed by healthcare providers with few restrictions.
But some medical experts became concerned about the potential for tramadol dependence and misuse. In 2014, the Drug Enforcement Administration (DEA) made tramadol a controlled substance. Controlled substances have a greater risk for misuse and dependence than non-controlled substances.
If you’ve been prescribed tramadol, it may be helpful to know more about what its controlled substance classification means for you.
What drug class does tramadol belong to?
Tramadol belongs to a class of medications called opioids. Opioids are medications that treat moderate to severe pain. They work by turning on areas on your nerve cells called opioid receptors (chemical binding sites). These receptors block pain messages to the brain, which help you feel less pain.
Tramadol also raises the levels of certain chemicals in your body — norepinephrine and serotonin. It’s likely that this also helps relieve pain. But
All opioids are controlled substances. This means they have the ability to cause physical and mental dependence. Controlled substances are classified into five categories (schedules). Tramadol is a schedule IV (schedule 4) medication.
What does a controlled substance’s schedule mean?
Controlled substance schedules range from schedule I to schedule V (schedule 1 to 5). Schedule I substances, such as heroin, are illegal in the U.S. Prescription medications fall under schedules II to V.
The schedules are based on how likely a medication is to cause dependence or misuse. Schedule I has the most risk, and schedule V the least. Each schedule has different restrictions on how they’re prescribed. And individual medications may have more restrictions than others within their schedule.
Schedule IV controlled substances (like tramadol) have a lower risk of dependence and addiction than schedules I to III. But they have a higher risk than schedule V controlled substances. Benzodiazepines are another example of schedule IV controlled substances. These include medications like alprazolam (Xanax) and lorazepam (Ativan).
Most opioids are schedule II medications. These opioids have a much higher risk for misuse and dependence than tramadol. Some common examples are oxycodone (Roxicodone, OxyContin), morphine (MS Contin), and hydrocodone / acetaminophen.
Good to know: Medications are given a federal controlled substance schedule by the DEA. But individual states can change the schedule of a medication. The only catch is they can’t change the schedule of a medication to a lower-risk number (i.e. from Schedule II to Schedule III). But they can change the schedule to a higher-risk number (i.e. from Schedule IV to Schedule II. States can also make a non-controlled substance controlled if they feel the risk of misuse warrants it.
When did tramadol become a controlled substance?
The DEA made tramadol a controlled substance in July 2014. Many pharmacy and medical associations agreed with the DEA’s decision.
But some experts also disagreed. Some worried that making tramadol a controlled substance would make it harder for people to get it when needed. And some experts didn't think there was enough evidence to support making tramadol a controlled substance.
Is tramadol a controlled substance in all states?
Yes, tramadol is a controlled substance in all states. The DEA is a national agency. If the DEA classifies a medication as a controlled substance, it applies to the entire U.S.
But prior to the DEA rule that made tramadol a schedule IV medication, ten states had classified tramadol as a controlled substance. So tramadol was only a controlled substance in those states before July 2014.
What are the restrictions on prescriptions for controlled substances like Tramadol?
Schedule IV medications like tramadol have certain restrictions on how they’re prescribed. For example, prescriptions for schedule IV medications are only valid for 6 months in most states. Prescriptions for non-controlled medications are usually valid for up to 1 year.
Also, healthcare providers can only provide up to five refills with each prescription of tramadol. And the prescription can only be transferred between pharmacies one time if transfers are allowed in your state.
Healthcare providers also have specific record-keeping requirements for prescribing tramadol. And pharmacies have specific requirements for stocking and dispensing tramadol.
These restrictions help improve the safety of medications like tramadol. They also help make it less likely that anyone will become dependent on tramadol. All but one state also keep records of controlled substance prescriptions through an online database. These are called prescription drug monitoring programs (PDMPs). Prescribers and pharmacists check PDMPs to make sure a controlled substance isn’t already being prescribed or filled elsewhere. They help healthcare providers improve prescribing methods. They also help lower the risk of opioid misuse or similar concerns.
Good to know: The laws and restrictions for controlled substances can vary from state to state. Your state may have stricter rules than the federal government requires. So it’s best to talk to your provider or pharmacist if you have questions about filling a tramadol prescription in your state.
The bottom line
Tramadol is an opioid pain medication. It became a schedule IV (schedule 4) controlled substance in July 2014. Tramadol has a higher potential for misuse and dependence than non-controlled substances. But it has a lower risk than most other opioids, which are schedule II (schedule 2) medications.
A prescription for tramadol is only valid for up to 6 months and a maximum of five refills. But restrictions vary, depending on where you live. Talk to your healthcare provider if you have questions about tramadol.
If you or someone you know struggles with substance use, help is available. Call SAMHSA’s National Helpline at 1-800-662-HELP (4357) to learn about resources in your area.
Why trust our experts?
References
Centers for Disease Control and Prevention. (2021). Prescription drug monitoring programs (PDMPs).
Dhesi, M., et al. (2023). Tramadol. StatPearls.
Fulco, C. E., et al (1995). Development of medications for the treatment of opiate and cocaine addictions: Issues for the government and private sector. Institute of Medicine (US) Committee to Study Medication Development and Research at the National Institute on Drug Abuse.
National Institute on Drug Abuse. (1997). The brain’s response to opioids.
Rising Pharma Holdings, Inc. (2023). Tramadol hydrochloride [package insert].
Substance Abuse and Mental Health Services Administration. (2023). SAMHSA’s national helpline.
United States Drug Enforcement Administration. (2014). Schedules of controlled substances: Placement of tramadol into Schedule IV. Federal Register.
United States Drug Enforcement Administration. (2018). Drug scheduling.
United State Drug Enforcement Administration. (2023). Controlled substances listed in Schedules III, IV, and V. Code of Federal Regulations.
United States Drug Enforcement Administration. (2023). Tramadol.
