New molecular entities: Lunesta

Efficacy. Eszopiclone's efficacy in reducing sleep latency and improving sleep maintenance was established in 6 placebo-controlled trials of patients (N=2,100, aged 18-86 y) with chronic and transient insomnia. Elderly patients (n=523) were studied in 2 of these trials. Across all studies, eszopiclone significantly decreased sleep latency and improved measures of sleep maintenance (objectively measured as wake time after sleep onset [WASO] and subjectively measured as total sleep time).

Safety. Symptomatic treatment of insomnia should begin only after a careful evaluation of the patient for physical or psychiatric disorder. Sedative/hypnotic drugs should be administered with caution in patients exhibiting signs and symptoms of depression. Abnormal thinking and behavior changes have been reported in patients receiving sedatives/hypnotics. However, it is important to note that worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Symptoms similar to those associated with withdrawal from other CNS-depressant drugs have been reported following rapid dose decrease or abrupt cessation of sedative/hypnotic dosing. Patients should be cautioned against engaging in hazardous activities requiring complete mental alertness or motor coordination after taking eszopiclone because of the psychomotor impairment associated with sedatives/hypnotics. Patients should also be cautioned about potential impairment on the day following administration of eszopiclone. Eszopiclone is a Schedule IV controlled substance under the Controlled Substances Act. Physical and psychological dependence may result from the use of benzodiazepines and similar agents. The risk of abuse increases with the dose and duration of treatment, as well as with concomitant use of other psychoactive drugs. Patients with a history of drug or alcohol abuse are particularly susceptible to this risk, and these patients should be under careful surveillance when receiving eszopiclone or any other hypnotic. Some of the more common adverse events associated with eszopiclone include headache, dry mouth, dizziness, hallucinations, somnolence, rash, and unpleasant taste.

Cost. According to the manufacturer, the average wholesale price (AWP) of eszopiclone will be $3.70 per tablet.