Suboxone is a prescription-only, FDA-approved medication that is used for treating opioid use disorder.

While this medication can be effective in treating opioid use disorder (OUD), it is considered a controlled substance.

Continue reading to find out what this means!

Is Suboxone a Controlled Substance?

The Drug Enforcement Administration (DEA) classifies Suboxone as a Schedule III (3) controlled substance.

This is due to its main active ingredient being Buprenorphine. All medications containing Buprenorphine are considered Schedule III substances.

Therefore, Suboxone must be prescribed by a qualified physician or medical professional.

It can only be prescribed by physicians who meet certain qualifying requirements and are trained in opioid use disorder (OUD) diagnosis, treatment, and monitoring.

Suboxone, along with other Schedule III substances, has a low risk of leading to psychological or physical dependence.

There is a relatively low risk for Suboxone users developing a substance use disorder toward the medication, but the risk is still higher relative to schedule IV or V substances.

Whilst Suboxone can be highly effective in helping individuals overcome opioid use disorder, this controlled substance must be used under supervision from a qualified provider or treatment team.

This is to ensure the safety of the user and to lessen the risk of dependence on the substance.

What is a Controlled Substance?

Medications prescribed by healthcare providers for various diseases and purposes, fall into two categories – controlled and non-controlled substances.

Many prescriptions for infections or chronic health conditions are non-controlled, including over-the-counter medications.

However, substances that are active within the central nervous system (especially those that may lead to physical or psychological dependence) are controlled.

Such substances are controlled in order to increase the safety of use and to decrease the risk of dependence.

Certain controlled substances have very strict restrictions about how they can be filled, refilled, and used.

The Controlled Substances Act, which was created in 1970, established differing restrictions and classed certain substances into five separate ‘Schedules’.

Each schedule of substances is differentiated by its relative abuse potential, with Schedule I (1) substances having the highest potential for abuse or dependence and Schedule V(5) having the lowest.

Schedule Definition/Characteristics Examples
Schedule I No accepted medical use, high abuse potential Heroin, cannabis, LSD, ecstasy
Schedule II High abuse potential, severe dependence risk Fentanyl, oxycodone, amphetamine
Schedule III Moderate abuse potential, lower dependence risk Ketamine, codeine (<90mg), buprenorphine
Schedule IV Low abuse potential Xanax, diazepam, lorazepam
Schedule V Lowest abuse potential, limited narcotics quantities Cough medicines with <200mg codeine

Schedule I

Schedule I substances have no accepted medical use in the USA currently, are considered unsafe for medically supervised use, or have a high potential for abuse.

Examples of Schedule I substances include heroin, cannabis, LSD, and methylenedioxymethamphetamine (ecstasy).

Schedule II

Schedule II substances have a high potential for abuse. The use of such substances may lead to severe physical or psychological dependence. Schedule II substances tend to be considered narcotics and stimulants.

Examples of Schedule II narcotics include fentanyl, oxycodone, methadone, opium, or codeine.

Examples of Schedule II stimulants include amphetamine, methamphetamine, and methylphenidate (Ritalin).

Schedule III

Schedule III substances have a potential for abuse, but it is lower than that of the substances in Schedule I or II.

Abusing these substances may lead to low or moderate dependence. However, psychological dependence may still be high.

Examples of schedule III substances include medications or products that contain less than 90mg of codeine per dose, ketamine, benzphetamine, phendimetrazine, and buprenorphine (Suboxone).

Schedule IV

Schedule IV substances have a lower potential for abuse again.

Examples of Schedule IV substances include alprazolam (Xanax), carisoprodol (Soma), diazepam, lorazepam, and temazepam.

Schedule V

Schedule V substances have the lowest potential for abuse. Substances in this schedule tend to contain limited quantities of certain narcotics.

Examples include cough medicines containing less than 200mg of codeine per 100 mls or 100g, such as Robitussin or Phenergan with Codeine.

Suboxone as a Controlled Substance

As Suboxone contains Buprenorphine, a partial opioid agonist, it is considered a narcotic and is an opioid.

When one uses any drug or medication containing opioids, they risk becoming psychologically addicted to that substance.

Alternatively, they may become physically dependent and struggle to stop using the drug due to withdrawal symptoms occurring.

Suboxone is considered a Schedule III controlled substance. This means that while the potential for abuse or dependence is lower than that of Schedule I or II substances, it is still there.

For this reason, it is crucial that Suboxone is prescribed by qualified physicians under the correct circumstances.

It is important that Suboxone use is closely monitored and supervised, and that it is taken exactly as prescribed to minimize the potential for abuse and dependence (as well as to increase its effectiveness).

Methadone is another medication-assisted treatment option that contains Buprenorphine.

However, it is more habit-forming, so it is classed as a Schedule II substance.

Methadone is a full opioid, and oftentimes, people replace their existing opioid addiction with a methadone addiction when they use it to treat their OUD.

On the other hand, Suboxone contains Buprenorphine, which is only a partial opioid agonist.

It targets and activates the same receptors as opioids, but in a more targeted and less intense way so a user cannot feel ‘high’.

The side effects are also less intense, and the withdrawals are less severe. Buprenorphine works by targeting opioid receptors in order to prevent unpleasant withdrawals without producing an intensely pleasurable opioid ‘high’.

Suboxone Regulations and Implications

Being a controlled substance, Suboxone requires a prescription for use and should only be used under close medical supervision.

However, unlike other controlled substance medications that are used for opioid addiction (such as those with higher ratings in the Schedule system), Suboxone can be prescribed by your primary healthcare provider given they are qualified.

In order for a healthcare practitioner to prescribe Suboxone, they must have undergone special training relating to opioid use disorder diagnosis, treatment, and therapy.

As of 2023, physicians no longer need to apply for a waiver to prescribe medications containing Buprenorphine such as Suboxone.

Practitioners do need to have a registration with the Drug Enforcement Agency (DEA) which includes authority to prescribe schedule III substances.

Conclusion

This article has explained why Suboxone is considered a controlled substance, the schedule rating system of controlled substances, and why Suboxone is classified within Schedule III.

Suboxone can be an effective and useful tool in helping one to overcome opioid dependence or addiction.

However, because of the potential abuse and dependence risks involved, it is of profound importance that it is used only under guidance and supervision from a qualified professional – whether that’s a primary healthcare provider or a specialized treatment team.

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