Lunesta Controlled Substance Status: Drug Classification & Risks

Dr. Olly Smith
Brittany Ferri
Written by Dr. Olly Smith on 25 April 2025
Medically reviewed by Brittany Ferri on 25 April 2025

Lunesta (eszopiclone) is a hypnotic drug prescribed by doctors to treat sleeplessness (insomnia). In the U.S., it’s classified as a Schedule IV controlled substance, requiring a suitably qualified and licensed healthcare professional to prescribe it.

This article explores why Lunesta is a controlled drug and some important risks to be aware of.

This information is not intended to replace professional medical advice. If you or a loved one is concerned about the impact of insomnia or substance misuse, seek support from your healthcare provider. 

Key takeaways:
  • Lunesta (eszopiclone) is a Schedule IV controlled substance.
  • It has a low (but not zero) potential for addiction, dependence, and abuse.
  • Other sedative medications are available with varying levels of associated risks.
a close up of a hand holding a Lunesta pill on one hand and a glass of water on the other

Lunesta drug classification: Is it a controlled substance?

So, is Lunesta a controlled substance? Yes. In the U.S., Lunesta (eszopiclone) is a Schedule IV controlled drug under the Controlled Substances Act (CSA). As such, it can only be prescribed by a suitably trained healthcare professional who will have obtained a Drug Enforcement Administration (DEA) license.

There are five Schedule classifications, organized by a drug’s accepted medical use and abuse potential:

  • Schedule I - Drugs with no currently accepted medical use (e.g., cannabis or ecstasy).
  • Schedule II - Drugs with an accepted medical use that have a high potential for abuse (e.g., methamphetamine or fentanyl).
  • Schedule III - Drugs with an accepted medical use that have a medium to low potential for dependence (e.g., anabolic steroids or ketamine).
  • Schedule IV - Drugs with an accepted medical use that have a low potential for abuse or dependence (e.g., Xanax and Lunesta).
  • Schedule V - Drugs with an accepted medical use that have a lower potential for abuse than Schedule IV, consisting of preparations containing limited amounts of certain narcotics (e.g., cough medicine with <200mg of codeine per 100ml).

Why is Lunesta a controlled substance?

The reason for Lunesta’s drug classification as a Schedule IV controlled substance is down to its small potential for abuse and dependence. Schedule IV contains other benzodiazepine and non-benzodiazepine hypnotic drugs for the same reason, including:

  • Xanax (alprazolam)
  • Soma (carisoprodol)
  • Ambien (zolpidem)
  • Valium (diazepam)
  • Ativan (lorazepam)

Can Lunesta be addictive?

Lunesta has a small potential for addiction if misused at greater than prescribed doses or alongside other substances of abuse. Studies have shown that high doses of Lunesta can produce euphoric effects similar to those experienced in diazepam misuse.

Taking Lunesta alongside benzodiazepines (Valium), opioids (fentanyl), or alcohol increases the risk of dangerous adverse effects or overdose.

There is a very small risk that people taking Lunesta may develop a physical or psychological dependence on the drug. This risk is increased in people with a history of previous alcohol or substance misuse.

Prescribing regulations and safe use

Because of Lunesta’s schedule classification, there are specific prescribing regulations that healthcare professionals must follow:

  • The clinician must have a DEA license.
  • Pharmacies can only dispense up to 5 refills before a new prescription is required.
  • A maximum of 90 days of supply can be dispensed per allocation.
  • Clinicians must follow usual prescribing good practice and any relevant local laws.

To minimize the risk of addiction, dependence, and adverse effects, Lunesta should only be taken at the prescribed dose and frequency. Healthcare professionals should monitor for side effects or signs of abuse, stopping the medication if concerns arise.

Lunesta vs. Alternatives

Healthcare providers may prescribe one of several alternative sedative medications when treating insomnia.

Lunesta vs. Ambien (zolpidem)

Ambien is another non-benzodiazepine hypnotic drug. It has similar therapeutic effects, side effects, and dependence potential to Lunesta.

Ambien is considered slightly more potent than Lunesta, helping you fall asleep faster (although Lunesta may help you stay asleep longer). However, unlike Lunesta, which has no maximum recommended use duration, Ambien is only intended for short-term use.

Lunesta vs. Xanax (alprazolam) or Valium (diazepam)

Xanax and Valium belong to a class of medications called benzodiazepines. They also share similar therapeutic effects and side effects to Lunesta.

However, evidence indicates that benzodiazepines may have a slightly greater risk of dependency and potential for abuse. This may be due to their more potent effects, causing increased sedation for a longer period of time than Lunesta.

Are there non-controlled alternatives to Lunesta?

Several non-controlled drugs for the treatment of insomnia are available as an alternative to Lunesta:

  • Rozerem (ramelteon): A prescription medication that regulates melatonin (a natural sleep-wake cycle chemical).
  • Benadryl (diphenhydramine): An over-the-counter medication with mild sedative effects.
  • Unisom (doxylamine): An over-the-counter medication with mild sedative effects.

Final thoughts

Lunesta is a Schedule IV controlled substance that is prescribed to treat sleeplessness. When taken as prescribed, it has a low risk of addiction, dependence, and abuse.

Other insomnia medications are available with slightly greater, similar, or lower associated risks. Speak to your healthcare provider to determine which drug is best for you.

FAQs

Common questions about Lunesta

Is Lunesta a narcotic?

Medically, the term ‘narcotic’ refers to a substance used to treat moderate to severe pain. As such, Lunesta is not a narcotic. However, the term is often used colloquially to refer to controlled substances with some level of addiction risk (including Lunesta).

Can you get addicted to Lunesta?

It is unlikely that you will become addicted to Lunesta. However, studies have shown that addiction and dependence are possible when misused (at higher than prescribed doses or for longer than intended).

What happens if you stop taking Lunesta suddenly?

If you wish to stop taking Lunesta, speak to your healthcare provider first. A small number of people experience adverse effects when stopping Lunesta suddenly, including:

  • Anxiety
  • Abnormal or vivid dreams
  • Nausea
  • Upset stomach

Are there safer alternatives for treating insomnia?

Lunesta is considered very safe, with a low risk of addiction and dependence when taken as prescribed. However, medications like Rozerem, Benadryl, and Unisom may be effective in treating insomnia with even fewer associated risks.

Was this page helpful?

Your feedback allows us to continually improve our information

Resources:

  1. LUNESTA® (eszopiclone) tablets. (2004). www.accessdata.fda.gov.
  2. Kenny, B. J., & Preuss, C. V. (2024, January 9). Pharmacy Prescription Requirements. Nih.gov; StatPearls Publishing.
  3. DEA. (2018, July 10). Drug Scheduling. www.dea.gov; United States Drug Enforcement Administration.
  4. Gunja N. (2013). The clinical and forensic toxicology of Z-drugs. J Med Toxicol, 9(2):155-62.
  5. Lunesta vs Ambien: How do they compare? (2024). Drugs.com.
  6. Nonbenzodiazepine - an overview | ScienceDirect Topics.
  7. Insomnia Medications | Sleep Medicine. Sleep.hms.harvard.edu.

Activity History - Last updated: 25 April 2025, Published date:


Reviewer

Brittany Ferri

PhD, OTR/L

Brittany Ferri, PhD, OTR/L is an occupational therapist, health writer, medical reviewer, and book author.

Activity History - Medically Reviewed on 24 April 2025 and last checked on 25 April 2025

Medically reviewed by
Brittany Ferri

Brittany Ferri

PhD, OTR/L

Reviewer

Recovered Branding BG
Ready to talk about treatment? Call today. (833) 787-9718
Helpline Information

Calls to numbers marked with (I) symbols will be answered or returned by one of the treatment providers listed in our Terms and Conditions, each of which is a paid advertiser.

In calling the helpline you agree to our Terms and Conditions. We do not receive any fee or commission dependent upon which treatment or provider a caller chooses.

There is no obligation to enter treatment.

Access State-Specific Provider Directories for detailed information on locating licensed service providers and recovery residences in your area.

For any specific questions please email us at info@recovered.org

Similar pages

Ambien (Zolpidem)

5 minutes read

Zaleplon (Sonata)

7 minutes read