Eszopiclone

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Side Effects & Adverse Reactions

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Legal Issues

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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).

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History

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Other Information

Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.82, and its empirical formula is C17H17ClN6O3. Eszopiclone has a single chiral center with an (S)-configuration. It has the following chemical structure:

Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).

Eszopiclone is formulated as film-coated tablets for oral administration. Eszopiclone tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, anhydrous lactose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, polysorbate 80 (for 1 mg & 2 mg), FD&C Blue #2 (for 1 mg & 3 mg), FD&C Yellow #6 (for 3 mg) and FD&C Red #40 (for 3 mg).

Sources

Eszopiclone Manufacturers

Direct Rx

Eszopiclone | Direct Rx

Use the lowest effective dose for the patient.
2.1 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 eszopiclone tablets 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 (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Preferred Pharmaceuticals, Inc.

Eszopiclone | Preferred Pharmaceuticals, Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone tablets 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 (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Preferred Pharmaceuticals, Inc.

Eszopiclone | Preferred Pharmaceuticals, Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warnings and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Preferred Pharmaceuticals, Inc.

Eszopiclone | Preferred Pharmaceuticals, Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone tablets 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 (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
A-s Medication Solutions Llc

Eszopiclone | A-s Medication Solutions Llc

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see WARNING AND PRECAUTIONS (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see CLINICAL PHARMACOLOGY (12.3)].

No Recall
A-s Medication Solutions Llc

Eszopiclone | A-s Medication Solutions Llc

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warnings and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Mylan Institutional Inc.

Eszopiclone | Mylan Institutional Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone tablets 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 (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warnings and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Direct Rx

Eszopiclone | Direct Rx

2.1 Dosage in Adults
The dose of eszopiclone tablets should be individualized. The recommended starting dose for eszopiclone tablets 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 (5)].
Use in Geriatric Patients
The recommended starting dose of eszopiclone tablets 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: Special Populations (5.7)].
Use in Patients with Hepatic Impairment
The starting dose of eszopiclone tablets should be 1 mg in patients with severe hepatic impairment. Eszopiclone tablets should be used with caution in these patients.
Use with CYP3A4 Inhibitors
The starting dose of eszopiclone tablets should not exceed 1 mg in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors. If needed, the dose can be raised to 2 mg.
Use with CNS depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology: Pharmacokinetics (12.3)].

No Recall
Preferred Pharmaceuticals, Inc.

Eszopiclone | Preferred Pharmaceuticals, Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
Thetotal doseof eszopiclone should not exceed 2 mgin elderly ordebilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Preferred Pharmaceuticals, Inc.

Eszopiclone | Preferred Pharmaceuticals, Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
Thetotal doseof eszopiclone should not exceed 2 mgin elderly ordebilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Sun Pharma Global Fze

Eszopiclone | Sun Pharma Global Fze

Use the lowest effective dose for the patient.
2.1 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 eszopiclone tablets 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 (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Avkare, Inc.

Eszopiclone | Avkare, Inc.

2.1 Dosage in Adults
The dose of eszopiclone tablets should be individualized. The recommended starting dose for eszopiclone tablets 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 (5)].
Use in Geriatric Patients
The recommended starting dose of eszopiclone tablets 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 (5.7)].
Use in Patients with Hepatic Impairment
The starting dose of eszopiclone tablets should be 1 mg in patients with severe hepatic impairment. Eszopiclone tablets should be used with caution in these patients.
Use with CYP3A4 Inhibitors
The starting dose of eszopiclone tablets should not exceed 1 mg in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors. If needed, the dose can be raised to 2 mg.
Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].
Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Bryant Ranch Prepack

Eszopiclone | Bryant Ranch Prepack

2.1 Dosage in Adults
The dose of eszopiclone tablets should be individualized. The recommended starting dose for eszopiclone tablets 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 (5)].

Use in Geriatric Patients
The recommended starting dose of eszopiclone tablets 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: Special Populations (5.7)].

Use in Patients with Hepatic Impairment
The starting dose of eszopiclone tablets should be 1 mg in patients with severe hepatic impairment. Eszopiclone tablets should be used with caution in these patients.

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

Use with CNS depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology: Pharmacokinetics (12.3)].

No Recall
Bryant Ranch Prepack

Eszopiclone | Bryant Ranch Prepack

2.1 Dosage in Adults
The dose of eszopiclone tablets should be individualized. The recommended starting dose for eszopiclone tablets 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 (5)].

Use in Geriatric Patients
The recommended starting dose of eszopiclone tablets 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: Special Populations (5.7)].

Use in Patients with Hepatic Impairment
The starting dose of eszopiclone tablets should be 1 mg in patients with severe hepatic impairment. Eszopiclone tablets should be used with caution in these patients.

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

Use with CNS depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology: Pharmacokinetics (12.3)].

No Recall
Glenmark Generics Inc. Usa

Eszopiclone | Glenmark Pharmaceuticals Inc., Usa

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warnings and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
A-s Medication Solutions Llc

Eszopiclone | A-s Medication Solutions Llc

2.1 Dosage in Adults
The dose of eszopiclone tablets should be individualized. The recommended starting dose for eszopiclone tablets 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 (5)].
Use in Geriatric Patients
The recommended starting dose of eszopiclone tablets 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 (5.7)].
Use in Patients with Hepatic Impairment
The starting dose of eszopiclone tablets should be 1 mg in patients with severe hepatic impairment. Eszopiclone tablets should be used with caution in these patients.
Use with CYP3A4 Inhibitors
The starting dose of eszopiclone tablets should not exceed 1 mg in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors. If needed, the dose can be raised to 2 mg.
Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS (5.5)].
Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see CLINICAL PHARMACOLOGY (12.3)].

No Recall
A-s Medication Solutions Llc

Eszopiclone | A-s Medication Solutions Llc

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warnings and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Mylan Pharmaceuticals Inc.

Eszopiclone | Hi-tech Pharmacal Co., Inc.

Promethazine hydrochloride and phenylephrine hydrochloride syrup is contraindicated for children under 2 years of age (see WARNINGS-Black Box Warningand Use in Pediatric Patients).
The recommended doses are given in the following table:
Adults And Children 12 Years And Over
1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.
Children 6 To Under 12 Years Of Age
½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoonsful (30 mL) in 24 hours.
Children 2 To Under 6 Years Of Age
¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours.

No Recall
Dr. Reddy’s Laboratories Limited

Eszopiclone | Dr. Reddy's Laboratories Limited

Use the lowest effective dose for the patient.
2.1 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 eszopiclone tablets 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 (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warnings and Precautions (5.7)].
2 4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Teva Pharmaceuticals Usa Inc

Eszopiclone | H E B

take with a glass of water adults and children
12 years and over take 1 to 3 tablets
in a single daily dose children 6 to under
12 years of age take 1 tablet in a single
daily dose children under 6 years
of age ask a doctor

No Recall
Bryant Ranch Prepack

Eszopiclone | Bryant Ranch Prepack

2.1 Dosage in Adults
The dose of eszopiclone tablets should be individualized. The recommended starting dose for eszopiclone tablets 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 (5)].

Use in Geriatric Patients
The recommended starting dose of eszopiclone tablets 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: Special Populations (5.7)].

Use in Patients with Hepatic Impairment
The starting dose of eszopiclone tablets should be 1 mg in patients with severe hepatic impairment. Eszopiclone tablets should be used with caution in these patients.

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

Use with CNS depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.5)].

Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology: Pharmacokinetics (12.3)].

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Lupin Pharmaceuticals, Inc.

Eszopiclone | Ecosom.co.,ltd.

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Roxane Laboratories, Inc.

Eszopiclone | Roxane Laboratories, Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
Thetotal doseof eszopiclone should not exceed 2 mgin elderly ordebilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].

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Orchidpharma Inc

Eszopiclone | Orchidpharma Inc

Use the lowest effective dose for the patient.
2.1 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 eszopiclone tablets 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 (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].

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Proficient Rx Lp

Eszopiclone | Proficient Rx Lp

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
Thetotal doseof eszopiclone should not exceed 2 mgin elderly ordebilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Preferred Pharmaceuticals Inc.

Eszopiclone | Preferred Pharmaceuticals Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone tablets 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 (5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see Warning and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall
Preferred Pharmaceuticals Inc.

Eszopiclone | Preferred Pharmaceuticals Inc.

Use the lowest effective dose for the patient.
2.1 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 eszopiclone 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 (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone should not exceed 2 mg in elderly or debilitated patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors
In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warnings and Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

No Recall