Eszopiclone FDA Classification
Eszopiclone is classified as a Schedule IV controlled substance by the FDA under the Controlled Substances Act. 1
Regulatory Classification Details
Schedule IV designation places eszopiclone in the same category as benzodiazepines and other nonbenzodiazepine hypnotics (zaleplon and zolpidem), indicating recognized medical use with a lower potential for abuse compared to Schedule II or III substances 2, 1
Despite being chemically unrelated to benzodiazepines (it is a cyclopyrrolone derivative), eszopiclone shares some pharmacologic properties with benzodiazepines, which informed its scheduling classification 1, 3
Clinical Context of Scheduling
The Schedule IV classification reflects specific abuse and dependence considerations:
Abuse liability studies demonstrated that eszopiclone at doses of 6 mg and 12 mg (2-4 times the maximum recommended dose) produced euphoric effects similar to diazepam 20 mg in individuals with known histories of benzodiazepine abuse 1
At supratherapeutic doses, dose-related increases in amnesia and hallucinations were observed 1
Physical dependence risk increases with dose, duration of treatment, and concomitant use of other psychoactive drugs, particularly in patients with histories of alcohol/drug abuse or psychiatric disorders 1
Withdrawal symptoms (anxiety, abnormal dreams, nausea, upset stomach) occurred at 2% or less incidence following abrupt discontinuation in clinical trials 1
Prescribing Implications
As a Schedule IV controlled substance, eszopiclone requires standard controlled substance prescribing practices, including prescription monitoring and documentation 1
The American Academy of Sleep Medicine guidelines note that eszopiclone has no short-term usage restriction unlike some other hypnotics, reflecting its approval for long-term treatment despite its controlled status 2
Patients requiring prolonged treatment should be under careful surveillance, particularly those with risk factors for substance abuse 1