Is Ambien a Controlled Substance? Scheduling, Risks, and Safety

Ambien is the brand name for the sedative-hypnotic drug zolpidem tartrate. It is a prescription sleeping pill that has been utilized for the short-term management of insomnia. Ambien is available in several forms, including immediate-release tablets, extended-release tablets (Ambien CR), and an oral spray (Zolpimist). Generic versions of zolpidem are also available.

Zolpidem belongs to a class of drugs known as non-benzodiazepine hypnotic agents or z-drugs. Other members of this drug class include zaleplon (Sonata) and eszopiclone (Lunesta). These medications are similar in their mechanisms and effects to benzodiazepines but lack the same chemical composition. They are also subject to greater restrictions despite being technically legal to possess with a physician’s prescription.

A prescription for Ambien legally falls under a greater set of restrictions and regulations than OTC sleep aids for a reason. While zolpidem is among the most commonly prescribed sleeping pills in the country, it is a restricted substance due to its potential for abuse, dependence, and misuse. Knowing why and how it is restricted can help anyone using the drug understand the importance of using it only as prescribed.

What Schedule Is Ambien?

Ambien falls under Schedule IV of the Controlled Substances Act (CSA).[1] It is illegal to possess or distribute the drug without a valid prescription from a licensed medical professional.

In general, Schedule IV drugs have a relatively low potential for abuse compared to Schedule II and III drugs, but they are subject to restrictions concerning their clinical use. Ambien has been regulated this way due to its potential for dependence, abuse, and other harmful side effects.

Doctors can prescribe Schedule IV drugs but are often restricted in terms of dosage and the number of refills a patient can request. Pharmacies are also obligated to keep inventories of Schedule IV drugs and report them to relevant authorities.

Why Is Ambien a Controlled Substance?

Ambien has been categorized as a Schedule IV controlled substance due to its physiological effects and potential for abuse and dependence. The drug is similar in its mechanisms and effects to benzodiazepines, which are themselves classified as controlled substances.

The active ingredient in Ambien, zolpidem, potentiates the inhibitory effects of the neurotransmitter GABA (gamma-aminobutyric acid). This mechanism is responsible for the drug’s therapeutic effects on the central nervous system but also contributes to the development of tolerance and dependence with regular use, and the risk of abuse and dependence increases with the duration of treatment.[2]

Furthermore, the drug has a potential for recreational use due to its calming and euphoric effects at higher doses. Because of this, it has been placed under greater regulatory control as a Schedule IV substance.

How Does Ambien Compare to Other Drugs in Its Class?

Zaleplon (Sonata), eszopiclone (Lunesta), and zolpidem (Ambien) are comparable to one another in terms of mechanism, therapeutic effects, and potential for abuse.[3] However, they have slightly different indications, formulations, and active ingredients. They all affect the GABA receptors in the brain but do so to a different extent and for a different period of time.

Benzodiazepines are another class of drugs that are similar to z-drugs in terms of mechanism and effects. However, they tend to have a greater potential for abuse and addiction, and as such, many of them fall under Schedule III or Schedule II of the CSA. The development of z-drugs was partly motivated by the desire to create hypnotic medications with a lower potential for abuse.

Nevertheless, due to their impact on the GABA system, they still tend to cause psychological and physical dependence with regular use, which is why all three carry substance use disorder risk despite their lower schedule classification.

What Are the Risks of Taking Ambien?

There are several potential risks and dangers of taking Ambien. Most people who take the drug do not experience adverse effects, but some can be severe or even life-threatening.

Common side effects:

The most common side effects of Ambien are:

• Drowsiness, including next-day drowsiness in some patients.
• Dizziness.
• Headaches.
• Dry mouth.
• Changes in appetite or weight.

Dangerous side effects:

Unfortunately, there are also potential side effects of taking Ambien that are rare but severe or potentially life-threatening. The most dangerous side effects of the medication are:

• Complex sleep-related behaviors. Ambien can cause people to engage in complex activities such as sleep-driving or sleepwalking. The FDA has issued a boxed warning concerning this serious side effect of the drug, based on 66 identified cases of serious injury or death over 26 years of monitoring.[4] The risk of sleep-driving is highest when taking higher-than-recommended doses of the medication or using it in combination with other central nervous system (CNS) depressants such as opioids or alcohol. Some people have also reported cooking or eating while sleepwalking or engaging in other activities without being aware of it.
• Physical dependence. Taking Ambien regularly can lead to the development of tolerance and physical dependence. As a result, people who take the drug on a regular basis may need higher doses to achieve the same effects. Furthermore, stopping the medication can cause debilitating withdrawal symptoms, including rebound insomnia.
• Dangerous drug interactions. Taking Ambien in combination with other CNS depressants can lead to severe respiratory depression that can be life-threatening.[5]

Can Ambien Be Used Safely?

In general, Ambien is a safe and effective sleep aid when it is taken as directed for a short period of time. To minimize the risks associated with the drug, it should only be taken in the recommended dosages and for as long as directed by the physician. It should also not be combined with other CNS depressants such as opioids or benzodiazepines, and it should ideally only be taken when the person has an uninterrupted seven-hour window for sleep.

In most cases, treatment with Ambien should be as short as possible, since long-term use of the drug can be detrimental to one’s mental and physical health.[6] There are several non-addictive treatments for chronic insomnia that are available and should be considered as an alternative to regular use of sleeping pills.

Specifically, cognitive behavioral therapy for insomnia (CBT-I) has been found to be an effective way of treating long-term sleeping disorders. Maintaining a healthy sleep schedule and practicing good sleep hygiene also help.

Most people who have trouble sleeping find that a combination of CBT-I and short-term use of a hypnotic medication such as Ambien is the most effective way of treating their condition. This approach can minimize the potential risks and dangers of Ambien while helping the person overcome their insomnia.

How to Get Help for Ambien Addiction

If you have been taking Ambien and experience any of the following effects, it might be a sign that you have developed an addiction or dependence on the drug. You should speak with your doctor about your concerns in such cases:

• The need to take higher doses for the same effects.
• Inability to stop using the medication.
• Difficulty waking up or sleep disturbances following Ambien use.
• Development of dangerous side effects or complex sleep behaviors.

Sleeping pill addiction is a serious condition, but it is treatable. People who suspect that they have developed a dependence on the drug should speak with their doctor about their treatment options. The physician will be able to develop a tapering schedule that will gradually reduce the dosage and help the patient avoid severe withdrawal effects.

If the person has been struggling with substance abuse and has difficulty controlling their Ambien use on a long-term basis, they may benefit from professional treatment. Treatment centers that specialize in substance use disorders can provide the necessary forms of intervention to address the issue.