Eszopiclone, a single-isomer, non-
benzodiazepine hypnotic agent, is approved for use in the US for the treatment of
insomnia for patients who have difficulty falling asleep (sleep latency) as well as for those who have difficulty staying asleep (sleep maintenance). Efficacy in sleep maintenance has not been consistently demonstrated with previous
hypnotics, and long-term efficacy and safety data are lacking for these agents. In clinical trials,
eszopiclone 3 mg significantly improved objective and subjective sleep measures in transient and
chronic insomnia in adults. Nightly treatment with
eszopiclone 1 mg effectively induced sleep in elderly patients and the 2-mg dose effectively induced and maintained sleep. The ability of
eszopiclone 2 mg to significantly improve next-day functioning and daytime alertness (as demonstrated by a reduction in the number and duration of
naps) in the elderly is an important finding in clinical trials, and is unique to the class of
hypnotic agents for the treatment of
insomnia.
Eszopiclone was well tolerated in clinical trials < or = 12 months duration, with no clinically significant evidence of pharmacological tolerance,
rebound insomnia or dependence. The most frequently reported adverse event was unpleasant taste.
Eszopiclone is the only non-
benzodiazepine sedative-
hypnotic (in the Schedule IV class under the
Controlled Substances Act) to be evaluated as a long-term treatment for
chronic insomnia.