Is Ambien a controlled substance? Its zolpidem is Schedule IV.

The short answer

Yes. Zolpidem is listed in Schedule IV at 21 CFR 1308.14(c)(59) with DEA Controlled Substances Code Number 2783. "Ambien" is a brand name and does not appear in the schedule text; the listing is for the substance.

Two sources decide this. The statute is Title 21 U.S.C. 812, part of the Controlled Substances Act, which sets the tests for each schedule. The regulation is 21 CFR part 1308, sections 1308.11 to 1308.15, which lists the substances one by one. A reader who wants to know whether Ambien is a controlled drug needs only the second: the list.

The CFR text below comes from the eCFR for the issue current through October 29, 2026, and the statute from the 2024 U.S. Code edition on govinfo. This is a classification page only, with no dosing, use, acquisition or synthesis information.

The zolpidem entry, quoted

Zolpidem is item (59) of the 61 items in 1308.14(c), the Schedule IV "Depressants" paragraph. The list is alphabetical, and the full run of the last ten entries is quoted further down this page.

Two neighbours have similar names but are different substances with their own lines: zaleplon (58) with code 2781 and zopiclone (60) with code 2784. The lead-in of the paragraph extends each entry to "its salts, isomers, and salts of isomers" where such forms exist, so a product containing a zolpidem salt is covered by the zolpidem line.

The paragraph also holds newer entries such as (17) Daridorexant 2410 and (32) Lemborexant 2245. They show that the schedules grow by rulemaking, so the current text is the one to read.

Brand names versus substances

The schedules list substances, not products. Section 1308.14(a) says the schedule covers substances "by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section". Every entry is under an official or chemical name, and a text search of 1308.11 to 1308.15 for "Ambien" finds no match.

So the answer for a brand-name product depends on its ingredient. A product's ingredients are stated on its FDA-approved label, and FDA's DailyMed database publishes them.

What the Schedule IV findings are

Schedule IV is the second-lowest of the five federal schedules. Under 21 U.S.C. 812(b)(4) it holds substances with a low abuse potential relative to Schedule III, an accepted medical use, and a limited dependence risk relative to Schedule III. The statutory wording is quoted in full below.

The initial Schedule IV list in 812(c) does not name zolpidem. It entered the schedules later through rulemaking. Being listed here records a classification, and it says nothing about how any person uses a drug.

The Schedule IV listing, in the CFR's own words

The lead-in of 21 CFR 1308.14(c) reads:

(c) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

The last ten entries of the Schedule IV depressants at 1308.14(c), with their DEA code numbers:

• (52) Quazepam 2881
• (53) Remimazolam 2846
• (54) Suvorexant 2223
• (55) Temazepam 2925
• (56) Tetrazepam 2886
• (57) Triazolam 2887
• (58) Zaleplon 2781
• (59) Zolpidem 2783
• (60) Zopiclone 2784
• (61) Zuranolone 2420

What the statute requires for Schedule IV

Title 21 U.S.C. 812(b) says a drug or other substance "may not be placed in any schedule unless the findings required for such schedule are made". For Schedule IV the findings are: (A) The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III. (B) The drug or other substance has a currently accepted medical use in treatment in the United States. (C) Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.

These findings are the test for putting a substance in the schedule. They are not a medical statement. The phrase "relative to schedule III" matters: Schedule IV is defined by comparison with the schedule above it, not by an absolute measure of risk.

How to read and re-check a schedule listing

A schedule entry has a fixed shape. A lead-in sentence says which class of substance follows and often that the listing extends to salts, isomers and salts of isomers. Each line then names a substance and, in most sections, a four-digit DEA Controlled Substances Code Number. The opening paragraph of 1308.11 to 1308.14 says each substance "has been assigned the DEA Controlled Substances Code Number set forth opposite it". The number identifies the line. It is not a rating of risk, and a higher or lower number does not mean a stronger or weaker substance.

1. Open the section for the schedule you want: 21 CFR 1308.11 (Schedule I), 1308.12 (II), 1308.13 (III), 1308.14 (IV) or 1308.15 (V) in the eCFR.
2. Find the paragraph for the class of substance: opiates, opium derivatives, hallucinogenic substances, depressants, stimulants, narcotic drugs, anabolic steroids and so on, each introduced by a lead-in sentence.
3. Read the entry by its official or chemical name, not by brand name, and note the four-digit DEA Controlled Substances Code Number printed beside it.
4. Check for words such as "unless specifically excepted" or "except" in the lead-in or the line itself, which limit what the entry covers.
5. Confirm the date: the eCFR shows an "as of" date, and the schedules change by rulemaking.

Limits of this page

This page quotes the text of 21 CFR 1308.11 to 1308.15 as published in the eCFR, current through October 29, 2026 (last substantive amendment dates per the eCFR versioner: 1308.11 October 21, 2026, 1308.12 December 21, 2022, 1308.13 April 28, 2026, 1308.14 August 31, 2026, 1308.15 June 1, 2022), and parts of 21 U.S.C. 812. It reports federal classification only. It does not describe any state law, any registration, record-keeping or prescription requirement, any penalty, or any use of a drug, and it does not tell you whether a particular product, person or activity is lawful. The eCFR is an editorial compilation, not the official legal edition of the Federal Register, and the schedules change by rulemaking, so check the current text and DEA before relying on it. Questions about law go to a qualified attorney, and questions about a medicine go to a pharmacist or physician.

Sources

Sources opened and read November 2, 2026. The zolpidem entry (59, code 2783) and its two neighbours were checked again against the eCFR on November 12, 2026, and were unchanged.

• eCFR: 21 CFR 1308.14, Schedule IV (current through October 29, 2026) (read November 2, 2026)
• eCFR: 21 CFR part 1308, Schedules of controlled substances (current through October 29, 2026) (read November 2, 2026)
• GovInfo: 21 U.S.C. 812, Schedules of controlled substances, United States Code, 2024 Edition (read November 2, 2026)