ABSTRACT

Eszopiclone (Lunesta, Sepracor Inc., previously named Estorra), a non-benzodiazepine hypnotic agent, available in Europe since 1992, was approved in the USA by the Food and Drug Administration (FDA) on December 15, 2004 for the treatment of transient and chronic insomnia in adult patients >18 years of age.1 It is included in the group of sedatives and hypnotics called the ‘Z-hypnotics’, which consist of zolpidem (Ambien, Ambien CR), zaleplon (Sonata), and zopiclone (Imovane) (see Tables 29.1 and 29.2). Like the other Z-hypnotics, it is classified by the Drug Enforcement Agency (DEA) as a Schedule IV drug under the Federal Controlled Substances Act in the USA. Due to its rapid onset and longer half-life, it has efficacy in treating both sleep onset and sleep maintenance. It is the stereoselective isomer of zopiclone (Imovane, Aventis), which itself has been available in several countries outside the USA since 1987. Racemic zopiclone is marketed as 7.5 mg tablets that contain 3.75 mg of S-zopiclone, more than the highest dose (3 mg) of eszopiclone available in the USA. Eszopiclone’s unique temporary side effect is an unpleasant taste. The acquisition cost of eszopiclone is comparable to the cost of zolpidem or zaleplon, but greater than that of older sedative hypnotic agents, most of which are available generically. Promotions for Lunesta, as with other sedatives and hypnotics, are advertised directly to the US public on television and in national magazines.