ESZOPICLONE- eszopiclone tablet, film coated 
DirectRX

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ESZOPICLONE

Indications and Usage

Dosage and Administration

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)].

Dosage forms and strengths

Contraindications

Eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)].

Warnings and Precautions

Adverse Reactions

Drug Interactions

Use in Specific Populations

Drug abuse and Dependence

Overdosage

Description

Clinical Pharmacology

Nonclinical Toxicology

Clinical Studies

Information for Patients

Medication Guide

Package Label

Label

ESZOPICLONE 
eszopiclone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-991(NDC:68462-382)
Route of Administration ORAL DEA Schedule CIV    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE) ESZOPICLONE 1 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Color blue (light blue) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 382;G
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61919-991-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091166 12/01/2015
Labeler - DirectRX (079254320)
Establishment
Name Address ID/FEI Business Operations
DirectRX 079254320 repack(61919-991)

Revised: 12/2015
Document Id: 25eb24c7-052a-6eec-e054-00144ff8d46c
Set id: 25eb24c7-0529-6eec-e054-00144ff8d46c
Version: 1
Effective Time: 20151202
 
DirectRX