Is Ambien (zolpidem) a controlled substance?

Yes. Ambien, the brand name of zolpidem, is a Schedule IV controlled substance under US federal law. In the United Kingdom zolpidem is a Class C drug under the Misuse of Drugs Act 1971 and sits in Part 1 of Schedule 4 to the Misuse of Drugs Regulations 2001. Ambien is not a benzodiazepine by its label, though it acts at a site that carries that name.

What is Ambien?

Zolpidem tartrate is the active ingredient. The Ambien label (Sanofi-Aventis, DailyMed, published April 18, 2025) states in Section 1 that it is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. MedlinePlus says zolpidem belongs to a class of medications called sedative-hypnotics. The label's boxed warning is about complex sleep behaviors:

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN.

What schedule is Ambien?

Schedule IV. Zolpidem is listed in 21 CFR 1308.14, among the depressants in paragraph (c), and Section 9.1 of the Ambien label says:

Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.

Section 1306.22 of the same federal regulations sets the refill rules for Schedule III and IV prescriptions. A prescription may not be filled or refilled more than six months after the date it was issued, and an authorized prescription may not be refilled more than five times. Section 1306.21 allows a pharmacist to dispense Schedule IV drugs on a signed paper prescription, a faxed copy, an electronic prescription that meets the federal requirements, or an oral prescription that the pharmacist writes down promptly. States can add stricter rules, and the state board of pharmacy is the authority for them. See drug schedules for how Schedule IV compares with the other four.

Is Ambien a benzo?

No. The label does not call Ambien a benzodiazepine. Its highlights describe it as a "gamma-aminobutyric acid (GABA) A receptor positive modulator", and MedlinePlus places it with the sedative-hypnotics. In contrast, the Xanax label says "XANAX is a benzodiazepine" in its indications and in its Drug Abuse and Dependence section (see Is Xanax a controlled substance?).

The confusion has a source. Section 12.1 of the Ambien label, on mechanism of action, says:

Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

The words "benzodiazepine site" name a place on the receptor. They do not make zolpidem a benzodiazepine, and the label's own wording for the drug is a GABA A receptor positive modulator. The two drugs do share a legal status, since zolpidem and alprazolam are both Schedule IV drugs in the US and Class C, Schedule 4 Part 1 drugs in the UK. For the family itself, read what is a benzo.

Is Ambien a narcotic?

No. The NARC column of the DEA list shows "N" for zolpidem. Federal law defines a narcotic drug in 21 U.S.C. 802(17) as opium, opiates and their derivatives, poppy straw, coca leaves, cocaine, ecgonine and compounds containing them. Zolpidem is not any of these. See what is a narcotic.

What class and schedule is zolpidem in the UK?

The Home Office list of commonly encountered controlled drugs, updated April 1, 2025, shows zolpidem as Class C, Schedule 4 Part 1. We checked the legislation to see when that came about. The Misuse of Drugs Act 1971 (Ketamine etc.) (Amendment) Order 2014 (S.I. 2014/1106) inserts zopiclone into the Class C list "after Zolpidem". The 2014 amending regulations (S.I. 2014/1275) likewise add zaleplon and zopiclone to Part 1 of Schedule 4 next to the existing zolpidem entry. Zolpidem was therefore already in both places by 2014. We did not find the earlier instrument that first listed it, so we give no year for it.

The government's penalties page lists, for Class C, up to 2 years in prison, an unlimited fine or both for possession and up to 14 years, an unlimited fine or both for supply and production. The 2014 amending regulations describe Part 1 of Schedule 4 as covering controlled drugs subject to the requirements of regulations 22, 23, 26 and 27 of the 2001 Regulations. The regulations, not this page, set the details. More is on UK drug classes and schedules.

What does the label say about dependence?

Section 9.3 says:

Use of AMBIEN may lead to the development of physical and/or psychological dependence. The risk of dependence increases with dose and duration of treatment.

Section 9.2 adds that people with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem and should be monitored carefully. Section 9.3 also reports that sedative-hypnotics have produced withdrawal signs and symptoms after abrupt discontinuation. The label says the symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, convulsions and delirium.

These facts explain why zolpidem is scheduled. They are not advice. Anyone who has questions about a prescription for zolpidem should ask the prescriber or pharmacist, and in the UK NHS 111 can also help. For urgent trouble in the US, call the Poison Help line at 1-800-222-1222 or the local emergency number.

Related pages

• Trazodone, not controlled in either country
• Xanax (alprazolam), a benzodiazepine in Schedule IV
• Valium (diazepam), another Schedule IV benzodiazepine
• All drugs with their US schedule and UK class

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