ZALEPLON - zaleplon capsule
Aurobindo Pharma Limited
Zaleplon Capsules USP CIV
(zal' e plon)
Read this Medication Guide before you start taking zaleplon 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. You and your doctor should talk about zaleplon when you start taking it and at regular checkups.
What is the most important information I should know about zaleplon?
Zaleplon may cause serious side effects including complex sleep behaviors that may cause serious injury and death. After taking zaleplon, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with zaleplon whether or not you drink alcohol or take other medicines that make you sleepy.
Reported activities include:
1. Take zaleplon exactly as prescribed
2. Do not take zaleplon if you:
3. Stop taking zaleplon and call your doctor right away if you find out that you have done any of the above activities after taking zaleplon.
What is zaleplon?
Zaleplon is a sedative-hypnotic (sleep) medicine. Zaleplon is used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. Zaleplon does not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night.
Zaleplon is not for children.
Zaleplon is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zaleplon in a safe place to prevent misuse and abuse. Selling or giving away zaleplon 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.
Do not take zaleplon capsules if you are allergic to anything in them. See the end of this Medication Guide for a complete list of ingredients in zaleplon capsules.
Zaleplon may not be right for you. Before starting zaleplon, 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, sometimes causing side effects. Do not take zaleplon 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 zaleplon?
What are the possible side effects of zaleplon?
Serious side effects of zaleplon 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 zaleplon.
Common side effects of zaleplon include:
These are not all the side effects of zaleplon. 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 zaleplon?
General Information about zaleplon
This Medication Guide summarizes the most important information about zaleplon. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zaleplon that was written for healthcare professionals.
If you would like more information, contact the Aurobindo Pharma USA, Inc. at 1-866-850-2876.
What are the ingredients in zaleplon capsules?
Active Ingredient: zaleplon
Inactive Ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch (maize), sodium lauryl sulfate, colloidal silicon dioxide, and stearic acid. The empty hard gelatin capsule shells contain FD&C Blue #1, FD&C Green #3, FD&C Yellow #5, titanium dioxide, and gelatin. The capsules are printed with edible ink containing black iron oxide and shellac.
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road East Windsor, NJ 08520
Aurobindo Pharma Limited
Hyderabad-500 032, India