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The applicant concluded that the dissolution profile and PK profiles cannot be affected by the number of tablets ( as the compared formulations behave identically), and that eszopiclone only the presence of (R)-zopiclone accounts for the observed PK differences .
The applicant is asked to compare all available data regarding zopiclone and eszopiclone (data on file, literature data) regarding clinically meaningful parameters (sleep parameters, development of tolerance and dependence, posology, eszopiclone duration of treatment, adverse events etc . lunesta patient information lunesta facts eszopiclone hypnite eszopiclone renal failure lunesta ) that will clearly show differences between those two compounds .
Applicant’s response: They presented a summary table of differences, that they attribute to (S)-zopiclone versus racemic zopiclone: generic name for lunesta will lunesta knock me out lunesta side effects rash eszopiclone anxiety shorter Tmax, lack of dose-dependency of Tmax , faster sleep onset, relative efficacy at the sub -receptors, beneficial anxiolytic and antidepressant effects, reduced next day memory impairment and fewer residual effects .
Overall conclusions on grounds for eszopiclone re-examination: The Applicant presented with the grounds for re-examination a detailed argumentation based on nonclinical, pharmacokinetic and preliminary clinical pharmacology data in healthy volunteers .
Following re-examination of the available data the CHMP considered that there is overall insufficient evidence to demonstrate a clinical influence of the (R)- isomer removal on the safety eszopiclone and efficacy properties of (S)-zopiclone in patients with insomnia .

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