MEDICATION GUIDE

QUAZEPAM (DOR-al)
(quazepam)
Tablets (C-IV)

Read the Medication Guide that comes with QUAZEPAM before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

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

QUAZEPAM may cause serious side effects that you may not know are happening to you. These side effects include:

• sleepiness during the day
• not thinking clearly
• act strangely, confused, or upset
• “sleep-walking” or doing other activities when you are asleep like:

     º   eating

     º   talking

     º   having sex

     º   driving a car

Call yourhealthcare provider right away if you find out that you have done any of the above activities after taking QUAZEPAM.

What is QUAZEPAM?

QUAZEPAM is a prescription medicine used to treat certain types of insomnia including difficulty falling asleep, waking up often during the night, or waking up early in the morning. 

It is not known if QUAZEPAM is safe and effective in children.  

QUAZEPAM is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep QUAZEPAM in a safe place to prevent misuse and abuse. Selling or giving away QUAZEPAM may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take QUAZEPAM?

: Do not take QUAZEPAM if you

• are allergic to quazepam or any of the ingredients in QUAZEPAM.  See the end of this Medication Guide for a complete list of ingredients in QUAZEPAM.
• have had an allergic reaction to other sleep medicines or sedatives such as benzodiazepines. Symptoms of a serious allergic reaction to quazepam can include:

     º    swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

     º    nausea and vomiting

     º    have sleep apnea, snoring, breathing or lung problems

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

What should I tell my healthcare provider before taking QUAZEPAM?

QUAZEPAMmay not be right for you. Before taking QUAZEPAM, tell your healthcare provider about all of your health conditions, including if you:

• have a history of depression, mental illness or, suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have lung disease or breathing problems
• are pregnant or plan to become pregnant. It is not known if QUAZEPAM can harm your unborn baby.
• are breastfeeding, or plan to breastfeed. QUAZEPAM can pass through your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take QUAZEPAM.

including prescription and nonprescription medicines, vitamins and herbal supplements. Tell your healthcare provider about all of the medicines you take,

Medicines can interact with each other, sometimes causing serious side effects. Do not take QUAZEPAM with other medicines that can make you sleepy unless your healthcare provider tells you to.

Know the medicines you take.  Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take QUAZEPAM?

• See “What is the most important information I should know about QUAZEPAM?”
• Take QUAZEPAM exactly as your healthcare providers tell you to take it.  
• Do not stop taking QUAZEPAM without talking to your healthcare provider, drug withdrawal symptoms can happen.
• QUAZEPAM comes in 15 mg tablets. Your healthcare provider may start your QUAZEPAM dose at 7.5 mg which is half a tablet.  Talk to your healthcare provider or pharmacist about your dose schedule.
• You should not drink alcohol while you are taking QUAZEPAM.
• 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.
• If you take too much QUAZEPAM or overdose, get emergency treatment right away.

What are the possible side effects of QUAZEPAM?

: QUAZEPAM may cause serious side effects, including

• See “ ” getting out of bed while not being fully awake and doing an activity that you do not know you are doing.What is the most important information I should know about QUAZEPAM?
• .  Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions. abnormal thoughts and behavior
• memory loss
• . Symptoms include swelling of the tongue or throat, and trouble breathing.  Get emergency medical help right away if you have these symptoms after taking QUAZEPAM. severe allergic reactions

Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using QUAZEPAM.

Common side effects of QUAZEPAM include :

• drowsiness
• headache
• feeling very tired
• dizziness
• dry mouth
• upset stomach

you may have symptoms for the next 1 to 2 days such as: After you stop taking a sleep medicine,

• trouble sleeping
• nausea
• flushing
• lightheadedness
• uncontrolled crying
• vomiting
• stomach cramps
• panic attack
• nervousness
• stomach area pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of QUAZEPAM. Ask your healthcare provider 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 QUAZEPAM?

• Store at room temperature between 68°F to 77° F (20°C to 25°C).
• Keep QUAZEPAM and all medicines out of the reach of children

General information about the safe and effective use of QUAZEPAM.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use QUAZEPAM for a condition for which it was not prescribed. Do not share QUAZEPAM with other people, even if they have the same symptoms that you have. It may harm them and it is against the law.

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

If you would like more information, go to http://www.QUAZEPAMforsleep.com or call Questcor Pharmaceuticals at 1-800-411-3065QUAZEPAM.

What are the ingredients in QUAZEPAM?

quazepam Active Ingredient:

cellulose, corn starch, FD&C Yellow No. 6 Al Lake, lactose, magnesium stearate, silicon dioxide, and sodium lauryl sulfate. Inactive Ingredients:

Distributed by Questcor Pharmaceuticals, Inc.

Hayward, CA  94545 USA This Medication Guide has been approved by the U.S. Food and Drug Administration.

(IS-1500-02   Rev. 04/13)