SONATA- zaleplon capsule 
Pfizer Laboratories Div Pfizer Inc

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MEDICATION GUIDE

SONATA® (Suh NAH tah) CAPSULES
C-IV
(Zaleplon CAPSULES)

Read this Medication Guide before you start taking SONATA 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 SONATA when you start taking it and at regular checkups.

What is the most important information I should know about SONATA?

SONATA may cause serious side effects including complex sleep behaviors that may cause serious injury and death.. After taking SONATA, 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 SONATA whether or not you drink alcohol or take other medicines that make you sleepy.

Reported activities include:

Important:

1.
Take SONATA exactly as prescribed
  • Do not take more SONATA than prescribed.
  • Take SONATA right before you get in bed, not sooner.
2.
Do not take SONATA if you:
  • 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 SONATA
  • 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 SONATA with your other medicines
  • cannot get a full night's sleep
3.
Stop taking SONATA and call your doctor right away if you find out that you have done any of the above activities after taking SONATA.

What is SONATA?

SONATA is a sedative-hypnotic (sleep) medicine. SONATA is used in adults for the short-term treatment of the symptom of trouble falling asleep from insomnia. SONATA does not treat other symptoms of insomnia which include waking up too early in the morning and waking up often during the night.

SONATA is not for children.

SONATA is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep SONATA in a safe place to prevent misuse and abuse. Selling or giving away SONATA 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 SONATA?

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

SONATA may not be right for you. Before starting SONATA, 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 SONATA 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 SONATA?

What are the possible side effects of SONATA?

Serious side effects of SONATA 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 SONATA.

Common side effects of SONATA include:

These are not all the side effects of SONATA. 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 SONATA?

General Information about SONATA

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

If you would like more information, contact the King Pharmaceuticals, LLC Professional Information Services at 1-800-776-3637.

What are the ingredients in SONATA?

Active Ingredient: zaleplon

Inactive Ingredients: microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, magnesium stearate, lactose, gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1, FD&C green #3, and FD&C yellow #5.

Rx only

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SONATA® is a registered trademark of King Pharmaceuticals Research and Development, LLC.

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

LAB-0616-4.0
Revised 12 2019

Revised: 12/2019
Document Id: 3c47f4a0-a30f-4ebf-b70b-47ae44e96be6
Set id: c8a6c478-1d05-47b2-c98d-99177395b762
Version: 16
Effective Time: 20191218
 
Pfizer Laboratories Div Pfizer Inc