Eszopiclone

Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone tablets are indicated for the treatment of insomnia.

12.1 Mechanism of Action The mechanism of action of eszopiclone as a hypnotic is unclear; however, its effect could be related to its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.

Following administration (1 mg/1 Tablet, Film Coated), Eszopiclone achieves Approximately 50% to 62% enteral uptake across labeled Eszopiclone strengths bioavailability and maximum serum exposure occurs 2–4 hours after eszopiclone dosing onset, governed by a Steady-state plasma equilibrium reached over 9–17 hour t½ intervals for Eszopiclone terminal half-life through predominantly hepatic biotransformation with renal elimination of polar eszopiclone conjugates.

Before initiating Eszopiclone at 1 mg/1 Tablet, Film Coated, clinical safety checklists rule out 4 contraindications; eszopiclone tablets are contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets .; eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone.. Logged tolerability patterns center on nausea (9.1% of reports), headache (8.5% of reports), insomnia (6.6% of reports).