Is Ambien a controlled substance?

Official answer

by Drugs.com

Yes, Ambien (generic name: zolpidem tartrate) is a sedative / hypnotic prescription drug and is classified by the DEA as Schedule IV federally controlled substance. It is used for the short-term treatment of adults who have trouble falling asleep (insomnia). It has potential for misuse and abuse.

Schedule IV drugs have a lower potential for abuse relative to other drugs in Schedule III (for example, codeine or buprenorphine) but can still be abused. Abuse may lead to limited physical or psychological dependence.

Examples of sedative / hypnotic medications in Schedule IV include:

Ambien has accepted medical uses in the U.S. and is approved by the FDA to treat insomnia (trouble sleeping) in adults. The immediate-release tablet (Ambien) is used if you have trouble falling asleep when you go to bed. The extended-release form (Ambien CR) has 2 layers: the first layer dissolves quickly to help you get to sleep, and the second layer dissolves more slowly to help you stay asleep.

Generic options that are available include the immediate-release and extended release oral tablet, and the oral sublingual form (brand name: Edular), which dissolves under your tongue. Zolpimist, an oral spray, is not yet available in a generic.

All forms of zolpidem tartrate are controlled substances in Schedule IV.

Why is Ambien a controlled substance?

Ambien is in the sedative / hypnotic category of drugs. Some medicines in this group have been associated with abuse, misuse and diversion. Abuse may lead to dependence or addiction. Keep Ambien in a safe place to prevent misuse and abuse. Diversion may occur if the drug is given or sold to someone to whom it was not originally prescribed.

Schedule IV drugs have a lower potential for abuse relative to other drugs in Schedule 3, but can still be abused. In addition, withdrawal symptoms like unease, insomnia or cramps may occur after the discontinuation of sedatives / hypnotics.

Like many controlled substances, Ambien has warnings for use while driving, drinking alcohol and taking with opioids or other CNS depressant medicine.

When did Ambien become a controlled substance?

Once a drug is approved by the FDA, the DEA then determines if a drug should be scheduled under the Controlled Substances Act, and which Schedule to place it in. Ambien (zolpidem tartrate) was first approved by the FDA in December 1992 and was then assigned to schedule IV by the DEA.

Does Ambien cause withdrawal symptoms?

Yes, Ambien and some other sedative / hypnotics have been associated with withdrawal symptoms upon abrupt discontinuation.

Withdrawal symptoms may include:

In Ambien studies, when a placebo (an inactive tablet) was given within 48 hours after the last Ambien dose, the following symptoms were reported at an incidence of 1% (1 in 100 people) or less:

The manufacturer also states that reports of abuse, dependence, and withdrawal have been received after Ambien was approved and placed on the U.S market.

Do not stop treatment without speaking to your healthcare provider first. Your doctor may develop a tapering schedule over a period of time when you stop treatment to help prevent side effects from withdrawal.

This is not all the information you need to know about Ambien (zolpidem tartrate) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.