What schedule is Suboxone?

Suboxone contains buprenorphine, which is a Schedule III controlled substance in the United States. The DEA lists buprenorphine with code 9064 and marks it Y in the narcotic column. In the United Kingdom, buprenorphine is a Class C drug and sits in Schedule 3 of the Misuse of Drugs Regulations 2001.

What is Suboxone?

Suboxone is a brand name. The DEA list shows it as one of the other names for buprenorphine, together with Buprenex, Temgesic and Subutex. The label cited here is for SUBOXONE sublingual film from Indivior, published on DailyMed on February 11, 2026.

The label says the film contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and that it is indicated for treatment of opioid dependence. It also says the product should be used as part of a complete treatment plan that includes counseling and psychosocial support.

The label describes the two ingredients as follows. Section 12.1 says buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor, and that naloxone is a potent antagonist at mu opioid receptors that produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally. Section 12.2 says comparisons of buprenorphine to full opioid agonists such as methadone and hydromorphone suggest that sublingual buprenorphine produces typical opioid agonist effects which are limited by a ceiling effect.

What schedule is Suboxone in the United States?

Schedule III. Buprenorphine is listed at 21 CFR 1308.13(e)(2)(i), in a paragraph headed narcotic drugs, with code 9064. Section 9.1 of the Suboxone label states that the film contains buprenorphine, a Schedule III controlled substance under the Controlled Substances Act. The Schedule II regulation, 21 CFR 1308.12(b)(1), names naloxone among the substances excluded from its opium and opiate group.

Under 21 U.S.C. 812(b), a Schedule III placement requires findings of a potential for abuse less than Schedules I and II, a currently accepted medical use in the United States, and that abuse may lead to moderate or low physical dependence or high psychological dependence. The wider system is explained on the drug schedules page.

For prescriptions, 21 CFR 1306.22 applies. A Schedule III or IV prescription cannot be filled or refilled more than six months after it was issued, and refills are capped at five. That is more flexible than Schedule II, where refills are prohibited, as seen on the fentanyl page.

Is Suboxone a narcotic?

In the legal sense, yes. The DEA list marks buprenorphine Y, and the Schedule III regulation groups it under narcotic drugs. The statutory definition is in 21 U.S.C. 802(17), and the DEA flag shows how the agency applies it to buprenorphine. The legal term is separate from the everyday one, and it is explained in what is a narcotic.

The medical and everyday meanings differ, and the label is the better guide to the drug itself. It calls buprenorphine a partial opioid agonist, so it belongs to the family covered in what is an opioid. Its schedule is lower than that of full agonists such as fentanyl.

What happened to the X-waiver?

Before 2023, a separate waiver program under section 303(g)(2) of the Controlled Substances Act, commonly called the X-waiver, applied to prescribers of these drugs for maintenance or detoxification treatment. The Consolidated Appropriations Act, 2023, Public Law 117-328, was signed December 29, 2022. Section 1262 of that law, titled "Eliminating additional requirements for dispensing narcotic drugs in schedule III, IV, and V for maintenance or detoxification treatment," strikes paragraph (2) of section 303(g) of the Controlled Substances Act, which was the waiver provision. Section 1263 is titled "Requiring prescribers of controlled substances to complete training."

The change does not affect the schedule. Buprenorphine remains Schedule III.

Why is buprenorphine controlled?

Section 9.2 of the label says buprenorphine, like morphine and other opioids, has the potential for being abused and is subject to criminal diversion. It adds that abuse of buprenorphine poses a risk of overdose and death, increased with alcohol and other substances, especially benzodiazepines. Section 9.3 says chronic administration produces physical dependence of the opioid type, with moderate withdrawal signs on abrupt discontinuation, and that the withdrawal syndrome is typically milder than with full agonists and may be delayed in onset.

The label also states that patients who continue to misuse, abuse or divert buprenorphine products or other opioids should be provided with or referred for more intensive and structured treatment. Section 9.3 also states that neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy. Decisions about a person's own treatment belong with their prescriber and pharmacist.

What is buprenorphine's status in the UK?

The Home Office list of the most commonly encountered controlled drugs (updated April 1, 2025) shows buprenorphine as Class C under the Misuse of Drugs Act 1971 and Schedule 3 under the Misuse of Drugs Regulations 2001. The classes are explained on UK drug classes. The Home Office list is not exhaustive, so the legislation on legislation.gov.uk is the final reference.

Related pages

• What is a narcotic?
• What is an opioid?
• Is tramadol a controlled substance?
• What schedule is fentanyl?

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