ZALEPLON  - zaleplon capsule 
H.J. Harkins Company, Inc.



Zaleplon Capsules C-IV

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?

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. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Zaleplon.

Reported activities include:


  1. Take Zaleplon exactly as prescribed
    • Do not take more Zaleplon than prescribed.
    • Take Zaleplon right before you get in bed, not sooner.
  2. Do not take Zaleplon if you:
    • drink alcohol
    • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Zaleplon with your other medicines
    • cannot get a full night’s sleep
  3. 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.

Who should not take Zaleplon?

Do not take Zaleplon if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Zaleplon.

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.

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What are the ingredients in ZALEPLON?

Active Ingredient: zaleplon

Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, FD&C blue #1, FD&C red #40 and black iron oxide. Zaleplon 5mg capsules also contain FD&C yellow #5.

Rx only

Manufactured by:
Pilerne Ind. Estate, Pilerne,
Bardez, Goa 403 511, India
Marketed by:
Ascend Laboratories, LLC
Montvale, NJ 07645
 This Medication guide has been approved by the U.S. Food and Drug Administration.

Repacked by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444

Revised: 8/2011
H.J. Harkins Company, Inc.