Is Lunesta a Controlled Substance? Schedule and Regulations

Lunesta is one of the most commonly prescribed pharmaceutical sleeping medications in the United States. However, fewer people know that it is a controlled substance according to federal law.

Is Lunesta a Controlled Substance?

Lunesta is a controlled substance, according to the Drug Enforcement Administration (DEA), classified under the Controlled Substances Act.[1] This status applies to prescription medicines with documented potential for abuse. Lunesta is a Schedule IV controlled substance. Schedule IV refers to drugs with an accepted medical use and a low potential for abuse or dependence compared to Schedule II and Schedule III.[2] Other Schedule IV drugs include benzodiazepines like Xanax (alprazolam) and Valium (diazepam), as well as other z-drugs and zopiclone. Thus, Lunesta has a lower potential for abuse than Schedule II drugs like OxyContin (oxycodone).

Nevertheless, all these drugs are subject to certain restrictions and regulations. For example, physicians must register with the Drug Enforcement Administration before prescribing any controlled substance.

Physicians can prescribe Lunesta with the ability to refill the prescription five times within six months.[3] Note that the rules for controlled substances vary depending on the state and the pharmacist’s policies and the physician’s expectations for the drug. Doctors also consider developing tolerance or potential dependence when prescribing Lunesta.

Why Is Lunesta a Controlled Substance?

Lunesta is a controlled substance because it has a documented potential for abuse or dependence. As a hypnotic medication, Lunesta suppresses the central nervous system, which can lead to misuse in some patients. One can also develop a tolerance to the drug fairly quickly, which encourages dosage increases and dependence.

The factors that contribute to a drug’s inclusion in a particular schedule include its effect on the mind and body, potential for abuse or dependence, medical use, and what happens during withdrawal.[4] Eszopiclone has met enough of these criteria to be placed in Schedule IV.

Lunesta went through the DEA’s standard scheduling review process for any new pharmaceutical substance, which weighs clinical studies on abuse potential against the drug’s therapeutic benefits. In a study of people with a documented history of benzodiazepine abuse, eszopiclone at higher-than-recommended doses produced euphoric effects comparable to diazepam, which is part of the evidence that supported its Schedule IV classification.[5]

Comparison to Benzodiazepines

Lunesta is not a benzodiazepine. However, the mechanism of action of eszopiclone is similar to that of these drugs, since both act on related receptors in the brain to produce sedation. Diazepam and alprazolam are generally considered to carry a somewhat higher potential for abuse and dependence than z-drugs like Lunesta, even though both drug classes fall under Schedule IV. Thus, these two classes of drugs are similar in terms of effect, but differ in degree of abuse potential.

Comparison to Other Z-Drugs

Zolpidem (Ambien), zaleplon (Sonata), and zopiclone are other z-class hypnotic medications with effects similar to eszopiclone. Like Lunesta, these drugs are included in Schedule IV and have restrictions on their use. In addition, all these medications list dependence and next-day impairment as adverse effects, which is why they warn against drinking alcohol while taking them.

Regarding the potential for abuse, Lunesta is similar to other z-class hypnotic medications. In particular, eszopiclone, zopiclone, and zolpidem have a comparable potential for dependence.

The FDA has also warned that people taking these medications may engage in complex sleep behaviors, such as sleepwalking, sleep-driving, or other activities performed while not fully awake.

In April 2019, the FDA added a boxed warning, its strongest type of warning, covering eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien) equally, after identifying dozens of cases of complex sleep behaviors that resulted in serious injuries or death.[6] The warning applies to all three medications with the same force, not to Lunesta to a lesser degree.

Side Effects and Risks of Lunesta

The most common side effects of Lunesta are dizziness, headaches, dry mouth, and next-day drowsiness. Next-day impairment can occur even at the recommended dose, and it can be dangerous.

In addition, eszopiclone has a significant number of potentially dangerous drug interactions, especially with alcohol and other central nervous system depressants. Thus, combining Lunesta with alcohol or opioids can lead to respiratory depression, overdose, or, in severe cases, death.

Doctors have extensive knowledge of these potential interactions, which is why they ask specific questions about other medications, vitamins, or herbs a person may take. Moreover, medical professionals can advise against using Lunesta based on this information.

Some of the more severe but rare side effects include memory loss, hallucinations, and sleep-driving, part of the broader category of complex sleep behaviors described above. Lunesta has also been associated with suicidal thoughts and attempts, so it is critical to consult a doctor if such effects occur.

Eszopiclone often causes daytime impairment as a side effect, which is especially risky for older adults, who also face a higher risk of falls when taking this drug. A physician usually starts with a lower dose to minimize these effects, considering the interaction with other medications a patient may take.

Dependence and Withdrawal Effects

Physical dependence on Lunesta can develop in some people, especially with long-term use or higher dosages. A doctor may prescribe a reduced dose to minimize this risk. A person may also experience uncomfortable withdrawal symptoms when stopping the medication. Rebound insomnia is among the most difficult of these symptoms to manage, since it can feel more severe than the insomnia that existed before treatment began.

With that being said, substance use disorder related to Lunesta is not common. The potential for abuse of this hypnotic medication is lower than that of benzodiazepines or opioids.

People who suspect that they have a dependence on Lunesta should not stop taking the drug abruptly, as this can cause severe withdrawal symptoms. Medical supervision, sometimes including a structured detox process, is required for any adjustment to the dosage, including stopping the medication.

A doctor can recommend a particular tapering schedule, the duration of which depends on the individual case but is usually several weeks. This approach minimizes the discomfort of withdrawal and reduces the risk of severe rebound insomnia. It is vital to consult a physician if one experiences uncomfortable side effects while taking Lunesta.

Alternatives to Lunesta

There are several approaches to treating insomnia without prescription medication. One of the most accessible options is a natural supplement called melatonin. It is available over the counter and does not have controlled substance status, although it tends to be less effective than Lunesta for chronic insomnia.

Another safe option is cognitive behavioral therapy for insomnia (CBT-I). It is not a drug, but rather a course of counseling designed to help someone fall asleep more easily and address potential causes of insomnia.

If neither melatonin nor CBT-I is suitable, a physician can recommend various alternative treatments, including over-the-counter sleeping aids. In particular, certain non-controlled sleeping medications might be suggested for intermittent use. In other cases, a drug like Lunesta may still be necessary despite the potential risks involved. In many cases, CBT-I and a sleep aid can be used together to get the benefits of both.