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Lunesta

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Lunesta

Lunesta

INDICATIONS

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).

DOSAGE AND ADMINISTRATION

Dosage In Adults

The dose of LUNESTA should be individualized. The recommended starting dose for LUNESTA for most non-elderly adults is 2 mg immediately before bedtime. Dosing can be initiated at or raised to 3 mg if clinically indicated, since 3 mg is more effective for sleep maintenance [see WARNINGS AND PRECAUTIONS].

Use in Geriatric Patients

The recommended starting dose of LUNESTA for elderly patients whose primary complaint is difficulty falling asleep is 1 mg immediately before bedtime. In these patients, the dose may be increased to 2 mg if clinically indicated. For elderly patients whose primary complaint is difficulty staying asleep, the recommended dose is 2 mg immediately before bedtime [see WARNINGS AND PRECAUTIONS].

Use in Patients with Hepatic Impairment

The starting dose of LUNESTA should be 1 mg in patients with severe hepatic impairment. LUNESTA should be used with caution in these patients.

Use with CYP3A4 Inhibitors

The starting dose of LUNESTA should not exceed 1 mg in patients coadministered LUNESTA with potent CYP3A4 inhibitors. If needed, the dose can be raised to 2 mg.

Use with CNS Depressants

Dosage adjustments may be necessary when LUNESTA is combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS].

Administration with Food

Taking LUNESTA with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of LUNESTA on sleep latency [see CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

LUNESTA is available in 1 mg, 2 mg and 3 mg strengths for oral administration.

LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side.

LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side.

LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side.

Storage And Handling

LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side, and are supplied as:

NDC 63402-193-10 bottle of 100 tablets

LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side, and are supplied as:

NDC 63402-191-10 bottle of 100 tablets

LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side, and are supplied as:

NDC 63402-190-30 bottle of 30 tablets

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough, MA 01752 USA. Revised: 2/2014

Last reviewed on RxList: 2/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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