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Nucynta Drug Class- Is Nucynta A Controlled Substance?

Nucynta Drug Class- Is Nucynta A Controlled Substance?


Nucynta is formulated with Tapentadol, a Schedule II controlled substance, as its active compound. 

Schedule II drugs are medicines with high potency for addiction, misuse, and abuse, leading to both psychological and physical dependency. Therefore, it is a prescription medication retailed with strict regulations and restrictions. 




Nucynta, the brand name of Tapentadol, is a centrally acting that relieves moderate to severe body pain in adults. It is classified as “opioid medicine,” thus having a potential risk for abuse and dependency. Thus making people wonder if Nucynta is a controlled substance.

This article aims to explore Tapentadol or Nucynta as a controlled substance, including its legal status and prescription regulations. 


Nucynta And Controlled Substance- An Overview 

Tapentadol is an FDA-approved treatment for severe chronic pain patients over 18 years old. It is marketed as an improved version of the currently available opioid analgesics with a better tolerability and safety profile. 

Tapentadol is available in immediate-release form (Nucynta IR) and extended-release form (Nucynta ER) under the brand name Aspadol and Nucynta [1]. 

When ordering Aspadol, it is essential to understand the regulations and precautions associated with controlled substances.

Controlled substances are medicines or compounds tightly controlled and regulated by the government for their potential risk of causing abuse and dependency [3]. The regulations apply to the compound's manufacturing, usage, retailing, storage, and distribution. 

Medical use of such controlled substances is only done after consulting a medical professional. They are not available over the counter and are retailed only through prescription from a licensed medical professional [3]. 



Points To Know Before Starting Controlled Substances- 

  • Long-term use of Controlled substances requires medical monitoring. 

  • Storing such medicines correctly is essential to prevent misuse. 

  • As these medications have a high risk of abuse, any changes in the dose should be made after consulting a doctor. 

  • If your friends and family have similar symptoms as you, do not share your prescription-controlled drug with them. 



Nucynta Drug Class Or Classification 

Tapentadol or Nucynta is an opiate (narcotic) pain medication that works by changing the way the brain and the nervous system respond to pain. 

Opioids are a broad group of pain medication that works with the brain cells; they travel through the blood and attach to the opioid receptors in the brain, thus blocking pain messages and boosting the feeling of pleasure. 


Is Nucynta A Controlled Substance?

Tapentadol, the active compound of Nucynta, is a Schedule II controlled substance [4]. 




Schedule II Drug Information

  • This Schedule includes medicines and substances with high potency for abuse.

  • They may lead to severe physical and psychological dependency [6]. 

  • These medicines are currently used in the United States with severe restrictions [7]. 


Who Makes Nucynta- What Are Schedule Drug Manufacturing Regulations?

Ortho-McNeil-Janssen Pharmaceuticals, Inc., a healthcare company of Johnson & Johnson, manufactures Nucynta. It is an orange round pill with "100," or the strength of the pill, written on one side and "O-M" on the other. 

Controlled substances such as Tapentadol (except Schedule I drugs) can be legally manufactured, distributed, and possessed in the United States when used for medical conditions approved by the FDA [11]. 

All drug companies, pharmacies, and distributors should follow the FDA and DEA regulations before retailing any scheduled drug. 


Tapentadol Or Nucynta Abuse Potential 

Aspadol or Nucynta are often abused for their euphoric or sedative effects. When taken in larger dosages than recommended or taken with other compounds or medications, it can enhance their effect, thus resulting in abuse. 

A study published in 2015 suggests that the risk of addiction to Tapentadol is comparatively lesser than other compounds [8]. It also states that Tapentadol abuse prevalence is significantly lower than all its comparators. 

According to a medical journal published in the year 2015, Recreational abusers online seem to be less interested in abusing Tapentadol compared to other opioid medicines [9]. 

The signs of Tapentadol abuse and dependency are listed below- 

  • Frequently taking the medication. 

  • Taking a higher dosage than the recommended. 

  • Decline in the performance at professional level. 

  • Having a strained relationship with friends and family. 

  • Visiting a number of doctors to get a Nucynta or Aspadol prescription. 


Aspadol Or Nucynta Prescribing And Refilling Regulations In The USA




Aspadol or Nucynta pain medications are not available over the counter and must be bought after consulting a doctor. 

Physicians should have a registration with the DEA for prescribing Scheduled Drugs, including Nucynta pills [11]. Medical practitioners such as general physicians, veterinarians, dentists, and mid-level practitioners can prescribe Nucynta or Tapentadol 100 mg tablets. 

The following information or factors should be present for a Nucynta prescription to be considered valid.

  • Patient's Name and Address.

  • The physician's name, address, and registration number with DEA.

  • Name of the medicine. 

  • Strength of the drug. 

  • Tapentadol Dosage prescribed and its quantity.

  • How to take these medicines. 

  • Number of authorized refills. 

In most places, a new prescription is needed every time you need a refill for your Schedule II medication. So, to make it easier, many online pharmacies let you buy Tapentadol without a prescription. However, proper administration guidelines should be followed in such cases to avoid any health risks.



Prescription Regulation Based On The States Of USA- 

Individual states may have additional restrictions apart from the ones set by the DEA. Some of these regulations based on the states are mentioned below. 

  • Many states of the USA, including New York, Florida, California, and Texas, follow additional Prescription Drug Monitoring Programs (PDMPs) on prescribing Tapentadol pills and other Schedule II medications [12]. 

  • The use of opioids such as Tapentadol has quantity limits in Massachusetts, Maine, Rhode Island, and Vermont. 

  • Hand-written prescriptions for Nucynta or Aspadol pills should be done on tamper-resistant prescription pads or electronically transmitted in states like Florida, New York, and California [13]. 



Legal Status Of Nucynta

The legal status of Tapentadol may vary between countries and jurisdictions. The classification of Tapentadol under the law in a few countries is listed below [14].    

  • AU: S8 (Controlled drug)

  • Canada (CA)- Schedule I

  • Germany (DE)-  Anlage III (Special prescription form required)

  • UK- Class A (Schedule II)

  • US- Schedule II


Is Nucynta A Controlled Substance- Our Final Thought On Its Safety Profile 

Nucynta, or Aspadol, is classified as a Schedule II controlled substance in the USA by the Drug Enforcement Administration (DEA) due to its higher risk of causing abuse and dependency. 

Tapentadol, along with its brand medication, is a prescription drug and is not available over the counter. However, Online pharmacies such as Health Naturo offer Tapentadol 100 mg without a prescription. 


Authors Note- 

It is essential to note that Health Naturo retails and ships Tapentadol tablets in compliance with all the regulations and restrictions to ensure that the medicine is delivered on time.

However, while buying Nucynta or Aspadol 100 mg or other Schedule II drugs, you must be aware of the prescription regulations in your country. 

If you have any queries or suggestions regarding the product or its regulation, you can reach us at [email protected]



No, Tapenadol is not considered under India's Narcotic Drugs and Psychotropic Substances Act.

Nucynta, or Tapentadol, is an Opioid analgesic that treats acute and severe chronic pain.

  • People below 18 and above 65 years.

  • People with kidney, liver, and heart disorders.

  • If you are taking any other treatment or medications.

Tapentadol is a Schedule II drug.

Tapentadol does not come under the NDPS (The Narcotic Drugs and Psychotropic Substances Act, 1985).

Yes, it is safe if Nucynta is taken in the correct dosage.

It is advisable not to take more than 600 mg of Nucynta in a day.

The use of Tapentadol has a risk of causing side effects and dependence. Thus, any change in the dosage should be done after consulting a doctor.

Other Schedule II analgesics with similar efficacy in relieving body pain are Hydromorphone, Oxycodone, Codeine, and Methadone. It is, however, essential to note that studies suggest that Tapentadol abuse is less frequent than most Schedule II pain medications.


  1. Tapentadol (Nucynta) for Treatment of Pain, aafp.org. 

  2. Tapentadol for pain; enoxaparin after prosthetic valve replacement, journals.lww.com.

  3. Controlled substance, cancer.gov.

  4. Mechanism of Action - Nucynta ER

  5. The Controlled Substances Act, dea.gov. 

  6. Controlled Substance Schedules, deadiversion.usdoj.gov.

  7. List of Schedule II drugs (US), Wikipedia.

  8. Tapentadol abuse potential: a postmarketing evaluation using a sample of individuals evaluated for substance abuse treatment, pubmed.

  9. Assessing Abuse Potential of New Analgesic Medications Following Market Release: An Evaluation of Internet Discussion of Tapentadol Abuse, academic.oup.com. 

  10. Tapentadol Abuse Potential: A Postmarketing Evaluation Using a Sample of Individuals Evaluated for Substance Abuse Treatment, academic.oup.com.

  11. DEA Drug Schedules, drugrehab. 

  12. Prescription Drug Monitoring Program, NCBI. 

  13. Tamper-Resistant Prescription Form Requirements, cdc.gov. 

  14. Tapentadol, Wikipedia.