Eszopiclone

LUNESTA ® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA 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). LUNESTA is indicated for the treatment of insomnia. LUNESTA has been shown to decrease sleep latency and improve sleep maintenance

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.

Use the lowest effective dose for the patient. Use the lowest dose effective for the patient. Recommended initial dose is 1 mg, immediately before bedtime, with at least 7-8 hours remaining before the planned time of awakening. May increase dose if clinically indicated, to a maximum of 3 mg. Geriatric or debilitated patients: Dose should not exceed 2 mg. Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg. Do not take with or immediately after a meal

LUNESTA is contraindicated in patients who have experienced complex sleep behaviors after taking LUNESTA. LUNESTA is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema. Patients who have experienced complex sleep behaviors after taking LUNESTA. Known hypersensitivity to eszopiclone

Boxed warning (complex sleep behaviors): Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of LUNESTA. Some of these events may result in serious injuries, including death. Discontinue LUNESTA immediately if a patient experiences a complex sleep behavior. WARNING: COMPLEX SLEEP BEHAVIORS. CNS Depressant Effects: Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients taking 3 mg dose against driving and against activities requiring complete mental alertness during the morning after use. Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use.

The following are described in more detail in the Warnings and Precautions section of the label: Complex Sleep Behaviors CNS Depressant Effects and Next-Day Impairment Need to Evaluate for Comorbid Diagnoses Severe Anaphylactic and Anaphylactoid Reactions Abnormal Thinking and Behavioral Changes Withdrawal Effects Timing of Drug Administration Special Populations Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

CNS Depressants: Additive CNS-depressant effects with combination use. Use with ethanol causes additive psychomotor impairment. Rifampicin: Combination use may decrease exposure and effects of LUNESTA. Ketoconazole: Combination use increases exposure and effect of LUNESTA. Dose reduction of LUNESTA is needed

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).