ESZOPICLONE- eszopiclone tablet, film coated 
Aidarex Pharmaceuticals LLC


Medication Guide

Eszopiclone (ES-zoe-PIK-lone) Tablets, Coated C-IV

Read the Medication Guide that comes with eszopiclone tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about eszopiclone tablets?

Eszopiclone tablets may cause serious side effects that you may not know are happening to you. These side effects include:

Call your healthcare provider right away if you find out that you have done any of the above activities after taking eszopiclone tablets.

The morning after you take eszopiclone tablets your ability to drive safely and think clearly may be decreased.

Do not take eszopiclone tablets if you:

What are eszopiclone tablets?

Eszopiclone tablets are a sedative-hypnotic (sleep) medicine. Eszopiclone tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:

Eszopiclone tablets are not for children.

Eszopiclone is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep eszopiclone tablets in a safe place to prevent misuse and abuse. Selling or giving away eszopiclone tablets may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take eszopiclone tablets?

Do not take eszopiclone tablets if you are allergic to anything in it.

See the end of this Medication Guide for a complete list of ingredients in eszopiclone tablets.

Eszopiclone tablets may not be right for you. Before starting eszopiclone tablets, tell your doctor about all of your health conditions, including if you:

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take eszopiclone tablets with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take eszopiclone tablets?

What are the possible side effects of eszopiclone tablets?

Possible serious side effects of eszopiclone tablets include:

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using eszopiclone tablets.

The most common side effects of eszopiclone tablets are:

These are not all the side effects of eszopiclone tablets. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store eszopiclone tablets?

General Information about eszopiclone tablets

This Medication Guide summarizes the most important information about eszopiclone tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about eszopiclone tablets that is written for healthcare professionals.

What are the ingredients in eszopiclone tablets?

Active Ingredient: eszopiclone

Inactive Ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. In addition, both the 1 mg and 3 mg tablets contain opadry blue (components of opadry blue are hypromellose, titanium dioxide, triacetin, polyethylene glycol 3350, FD&C Blue#2) and 2 mg tablet contain opadry white (components of opadry white are hypromellose, titanium dioxide and triacetin).

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for : OrchidPharma, Inc.
Princeton, NJ 08540, USA

Manufactured by : Orchid Healthcare
(A Division of Orchid Chemicals & Pharmaceuticals Ltd.)
Irungattukottai - 602 105, India

Revised: 05/2014


Revised: 3/2017
Aidarex Pharmaceuticals LLC