ZALEPLON- zaleplon capsule 
PD-Rx Pharmaceuticals, Inc.



Zaleplon Capsules USP CIV

(zal’ e plon)

Rx Only

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.

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 ofyour 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, please call West-Ward Pharmaceuticals Corp. at 1-800-962-8364.

What are the ingredients in Zaleplon Capsules USP?

Active Ingredient:  zaleplon USP

Inactive Ingredients: colloidal silicon dioxide, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. Each capsule shell contains: D&C Yellow #10, FD&C Blue #1, FD&C Yellow #6 (10 mg capsule shell only), gelatin, monogramming ink and titanium dioxide. The monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.

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

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724


Revised August 2019

Revised: 9/2023
PD-Rx Pharmaceuticals, Inc.