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Lunesta

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Lunesta

Indications
Dosage
How Supplied

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

Use the lowest effective dose for the patient.

Dosage In Adults

The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of LUNESTA following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS]. The total dose of LUNESTA should not exceed 3 mg, once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS].

Geriatric Or Debilitated Patients

The total dose of LUNESTA should not exceed 2 mg in elderly or debilitated patients.

Patients With Severe Hepatic Impairment, Or Taking Potent CYP3A4 Inhibitors

In patients with severe hepatic impairment, or in patients coadministered LUNESTA with potent CYP3A4 inhibitors, the total dose of LUNESTA should not exceed 2 mg [see WARNINGS AND PRECAUTIONS].

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: 5/2014.

Last reviewed on RxList: 5/29/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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