When was lunesta approved

An assessment of the efficacy and safety of eszopiclone in the treatment of transient insomnia in healthy adults. Sleep Med. Epub Dec Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia. Curr Med Res Opin. Lundbeck Takeda Pharmaceuticals U. Lunesta eszopiclone Profile. Profile Contact Information.

Currently Enrolling Trials Show More. General Information Lunesta eszopiclone formerly referred to as Estorra is a nonbenzodiazepine hypnotic agent approved for the long term treatment of insomnia and sleep maintenance. Clinical Results FDA approval of Lunesta was based on results from six clinical trials enrolling a total of subjects with chronic and transient insomnia. Transient Insomnia In a double-blind, parallel-group, single-night trial healthy adults were evaluated in a model of transient insomnia sleep laboratory in a comparing two doses of eszopiclone and placebo.

Chronic Insomnia The treatment of chronic insomnia was established in five controlled studies. Objective endpoints were measured for 4 weeks. Clinical results showed that both 2 mg and 3 mg were superior to placebo on LPS at 4 weeks. In addition, data showed that the 3 mg dose was superior to placebo on WASO. Clinical trials conducted overseas have confirmed that Lunesta is effective in treating transient and chronic insomnia and that it can be used over the long term without patients developing a tolerance to it.

In other words, its efficacy does not diminish over time. The marketing authorization application submitted and approved in Japan was based on data from the following domestic clinical trials as well as data from trials conducted overseas.

For Print April 17, Eisai Co. Overnight polysomnography PSG : a diagnostic tool that measures brain activity, eye movement and skeletal muscle activation to simultaneously record throughout the night the biophysical activity that occurs during sleep. Lunesta Tablets 1 mg Study Design: Multicenter, randomized, placebo-controlled, 5-way crossover, double-blind comparison Eligibility: Chronic insomnia patients aged between 21 and 64 years old who had been diagnosed with primary insomnia 72 subjects Primary Objective: To investigate and evaluate the dose response of eszopiclone and its superiority relative to placebo Treatment Arms: eszopiclone 1 mg, 2 mg, 3 mg, placebo, zolpidem tartrate 10 mg Treatment Period: Five treatment phases for two consecutive nights, each separated by a washout period of four to six days Co-primary Endpoints: Latency to persistent sleep LPS , as measured by an overnight polysomnography PSG , and sleep latency SL , as measured by subjective evaluation.

Study Design: Multicenter, randomized, parallel-arm, double-blind comparison Eligibility: Chronic insomnia patients aged between 20 and 84 years old subjects Primary Objective: To evaluate the long-term safety of eszopiclone Treatment Arms: Non-elderly adults: eszopiclone 2 mg, 3 mg; Elderly adults: eszopiclone 1 mg, 2 mg Treatment Period: Once daily for a period of 24 weeks Primary Endpoint: Adverse events.

News release search Search. Public Relations Department, Eisai Co. The recommended dose of eszopiclone is 2 mg for non-elderly adults and 1mg for elderly adults taken orally immediately before bedtime. Dosage may be adjusted according the patients symptoms; however, it should not excess 3 mg per dose for non-elderly adults or 2 mg per dose for elderly patients. Lunesta is a non-benzodiazepine type GABA A agonist non-benzodiazepine sedative hypnotic that was originally discovered and developed by Sunovion Pharmaceuticals Inc.

It is an S-enantiomer obtained through optical resolution of the racemic compound a mixture containing equal parts of the R- and S-enantiomers zopiclone. Clinical trials conducted overseas have confirmed that Lunesta is effective in treating transient and chronic insomnia and that it can be used over the long term without patients developing a tolerance to it. In other words, its efficacy does not diminish over time. The marketing authorization application submitted in Japan was based on data from the following domestic clinical trials as well as data from trials conducted overseas.

For Print January 18, Eisai Co.