MEDICATION GUIDE

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:

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driving a car ("sleep-driving")

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making and eating food

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talking on the phone

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having sex

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sleep-walking

Important:

1. Take zaleplon exactly as prescribed

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Do not take more zaleplon than prescribed.

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Take zaleplon right before you get in bed, not sooner.

2. Do not take zaleplon if you:

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have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking zaleplon

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drink alcohol

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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

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cannot get a full night’s sleep

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:

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have a history of depression, mental illness, or suicidal thoughts

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have a history of drug or alcohol abuse or addiction

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have kidney or liver disease

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have a lung disease or breathing problems

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are pregnant, planning to become pregnant, or breastfeeding

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?

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Take zaleplon exactly as prescribed. Do not take more zaleplon than prescribed for you.

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Take zaleplon right before you get into bed. Or you can take zaleplon after you have been in bed and have trouble falling asleep.

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Do not take zaleplon with or right after a meal.

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Do not take zaleplon unless you are able to get a full night’s sleep before you must be active again.

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Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

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If you take too much zaleplon or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of zaleplon?

Serious side effects of zaleplon include:

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getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about zaleplon?")

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abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.

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memory loss

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anxiety

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severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking zaleplon.

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:

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drowsiness

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lightheadedness

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dizziness

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“pins and needles” feeling on your skin

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difficulty with coordination

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You may still feel drowsy the next day after taking zaleplon. Do not drive or do other dangerous activities after taking zaleplon until you feel fully awake.

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You may have withdrawal symptoms when you stop taking zaleplon. Withdrawal symptoms include unpleasant feelings, stomach and muscle cramps, vomiting, sweating, shakiness, and rarely seizures. You may also have more trouble sleeping the first few nights after zaleplon is stopped. The problem usually goes away on its own after 1 or 2 nights.

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?

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Store zaleplon at room temperature between 68° and 77°F (20° to 25°C).

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Protect from light.

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Keep zaleplon and all medicines out of the reach of children.

General Information about zaleplon

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Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide.

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Do not use zaleplon for a condition for which it was not prescribed.

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Do not give zaleplon to other people, even if they have the same condition. It may harm them and it is against the law.

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 Hikma Pharmaceuticals USA Inc. 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.

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5 mg - A light green capsule with the product identification number “54 656” imprinted on both the cap and body.

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10 mg - A green capsule with the product identification number “54 888” imprinted on both the cap and body.

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

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

C50000505/01

Revised February 2023