Is Lunesta a Controlled Substance?
Yes, Lunesta (eszopiclone) is classified as a Schedule IV controlled substance under the Controlled Substances Act due to its potential for abuse and dependence. 1
Classification and Regulatory Status
Lunesta belongs to the class of non-benzodiazepine hypnotic agents, sometimes called "Z-drugs." Despite having a chemical structure different from benzodiazepines, it shares some pharmacologic properties with them and is regulated similarly:
- It is classified as a Schedule IV controlled substance by the Drug Enforcement Administration (DEA) 1
- Other medications in the same classification include benzodiazepines and other non-benzodiazepine hypnotics like zaleplon (Sonata) and zolpidem (Ambien) 1
- As a Schedule IV substance, Lunesta is considered to have a lower potential for abuse than Schedule II or III substances, but still carries risk for dependence 1
Abuse and Dependence Potential
The FDA drug label for Lunesta specifically addresses its potential for abuse and dependence:
- In studies of abuse liability, eszopiclone at doses of 6 and 12 mg (2-4 times the maximum recommended dose) produced euphoric effects similar to diazepam 20 mg 1
- At higher doses, there was a dose-related increase in reports of amnesia and hallucinations 1
- The risk of abuse and dependence increases with:
- Higher doses
- Longer duration of treatment
- Concomitant use of other psychoactive drugs
- History of alcohol or drug abuse
- History of psychiatric disorders 1
Clinical Implications
Healthcare providers should be aware of several important considerations when prescribing Lunesta:
- Patients should be monitored for signs of misuse, abuse, or addiction 1
- Patients with a history of substance use disorders require careful surveillance 1
- While clinical trials did not reveal evidence of a serious withdrawal syndrome, some withdrawal symptoms can occur, including anxiety, abnormal dreams, nausea, and upset stomach 1
- Unlike some other hypnotics, Lunesta is not limited to short-term use and has been studied for longer-term treatment of insomnia 2, 3
Comparison to Other Sleep Medications
- Pitolisant, a histamine-3-receptor inverse agonist approved for narcolepsy with cataplexy, is notable as the first and only treatment for this condition that is not scheduled as a controlled substance 4
- Other common hypnotics like zolpidem (Ambien) and zaleplon (Sonata) are also Schedule IV controlled substances 4
- Melatonin and extended-release melatonin, which are sometimes used for insomnia, are not controlled substances 4
Practical Considerations
When prescribing Lunesta, healthcare providers should:
- Inform patients that it is a federally controlled substance (C-IV) 1
- Advise patients to keep Lunesta in a safe place to prevent misuse and abuse 1
- Explain that selling or giving away Lunesta is against the law 1
- Consider that patients should be assessed for risk of abuse or addiction before prescribing 1
- Be aware that tolerance to hypnotic effects may develop after repeated use for a few weeks, although no development of tolerance to sleep parameters was observed over six months in clinical trials 1
In conclusion, Lunesta's status as a Schedule IV controlled substance reflects its potential for abuse and dependence, requiring appropriate prescribing practices and patient monitoring to minimize these risks while effectively treating insomnia.