against the law. Tell your doctor if you have everabused or have been dependent on alcohol,prescription medicines, or street drugs.Who should not take Zolpidem TartrateSublingual Tablet?• Do not take Zolpidem Tartrate Sublingual Tablet

if you are allergic to zolpidem or any otheringredients in Zolpidem Tartrate SublingualTablet. See the end of this Medication Guide fora complete list of ingredients in Zolpidem TartrateSublingual Tablet.

• Do not take Zolpidem Tartrate Sublingual Tabletif you have had an allergic reaction to drugscontaining zolpidem, such as Ambien, AmbienCR, Edluar, or Zolpimist.

Symptoms of a serious allergic reaction toZolpidem Tartrate Sublingual Tablet can include:• swelling of your face, lips, and throat that may

cause difficulty breathing or swallowing• nausea and vomitingZolpidem Tartrate Sublingual Tablet may not beright for you. Before starting Zolpidem TartrateSublingual Tablet, tell your doctor about all ofyour 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 kidney or liver disease• have a lung disease or breathing problems• are pregnant, planning to become pregnant, or

breastfeedingTell your doctor about all of the medicines youtake, including prescription and nonprescriptionmedicines, vitamins, and herbal supplements.Medicines can interact with each other, sometimescausing serious side effects. Your doctor will tellyou if you can take Zolpidem Tartrate SublingualTablet with your other medicines.Know the medicines you take. Keep a list of yourmedicines with you to show your doctor andpharmacist each time you get a new medicine.How should I take Zolpidem Tartrate SublingualTablet?• See “What is the most important information I

should know about Zolpidem TartrateSublingual Tablet”

• Read the “Instructions for Use” at the end of thisMedication Guide for detailed instructions onhow to take Zolpidem Tartrate Sublingual Tablet.

• Take Zolpidem Tartrate Sublingual Tablet exactlyas prescribed. Only take one Zolpidem TartrateSublingual Tablet per night if needed.

• Do not take Zolpidem Tartrate Sublingual Tabletif you drank alcohol that evening or before bed.

• While in bed, place the tablet under your tongueand allow it to break apart completely. Do notswallow it whole.

• You should not take Zolpidem Tartrate SublingualTablet with or right after a meal. Zolpidem TartrateSublingual Tablet may help you fall asleep fasterwhen you take it on an empty stomach.

• Call your health care provider if your insomniaworsens or is not better within 7 to 10 days. Thismay mean that there is another condition causingyour sleep problem.

• If you take too much Zolpidem TartrateSublingual Tablet or overdose get emergencytreatment.

What are the possible side effects of ZolpidemTartrate Sublingual Tablet?Zolpidem Tartrate Sublingual Tablet may causeserious side effects, including:• getting out of bed while not being fully awake

and do an activity that you do not know you aredoing. (See “What is the most importantinformation I should know about ZolpidemTartrate Sublingual Tablet?”)

• abnormal thoughts and behavior. Symptomsinclude more outgoing or aggressive behaviorthan normal, confusion, agitation, hallucinations,worsening of depression, and suicidal thoughtsor actions.

• memory loss• anxiety• severe allergic reactions. Symptoms include

swelling of the tongue or throat, troublebreathing, and nausea and vomiting. Getemergency medical help if you get thesesymptoms after taking Zolpidem TartrateSublingual Tablet.

Call your health care provider right away if youhave any of the above side effects or any otherside effects that worry you while using ZolpidemTartrate Sublingual Tablet.The most common side effects of ZolpidemTartrate Sublingual Tablet are:• Headache• Nausea• FatigueEven if you follow the Instructions for Use, youmay still feel drowsy in the morning after takingZolpidem Tartrate Sublingual Tablet. Do not driveor do other dangerous activities after takingZolpidem Tartrate Sublingual Tablet until you arefully awake.These are not all the side effects of ZolpidemTartrate Sublingual Tablet. Ask your health careprovider or pharmacist for more information.You may report side effects to FDA at1-800-FDA-1088.How should I store Zolpidem Tartrate SublingualTablet?• Store Zolpidem Tartrate Sublingual Tablet at room

temperature, 68° to 77°F (20° to 25°C). Protectfrom moisture.

• Only remove the blister from the pouch when youare ready to use Zolpidem Tartrate SublingualTablet.

Keep Zolpidem Tartrate Sublingual Tablet and allmedicines out of reach of children.General Information about Zolpidem TartrateSublingual TabletMedicines are sometimes prescribed for purposesother than those listed in a Medication Guide. Donot use Zolpidem Tartrate Sublingual Tablet for acondition for which it was not prescribed. Do notgive Zolpidem Tartrate Sublingual Tablet to otherpeople, even if you think they have the samesymptoms that you have. It may harm them and itis against the law.This Medication Guide summarizes the mostimportant information about Zolpidem TartrateSublingual Tablet. If you would like moreinformation, talk with your doctor. You can askyour doctor or pharmacist for information aboutZolpidem Tartrate Sublingual Tablet that is writtenfor healthcare professionals.What are the ingredients in Zolpidem TartrateSublingual Tablet?Active Ingredient: Zolpidem tartrateInactive Ingredients: Each Zolpidem TartrateSublingual Tablet includes the following inactiveingredients: Crospovidone, Povidone, Mannitol,Polyvinylacetate, colloidal silicon dioxide, sodium

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Zolpidem Tartrate (ZOL-pi-dem TAR-trateor zole-PI-dem TAR-trate) Sublingual TabletPhenylketonuricsPhenylalanine is a component of aspartame. Each3.5 mg and 1.75 mg Zolpidem Tartrate SublingualTablets contains 4.48 mg and 2.24 mg ofphenylalanine.Read the Medication Guide that comes withZolpidem Tartrate Sublingual Tablets before youstart taking it and each time you get a refill. Theremay be new information. This Medication Guidedoes not take the place of talking to your doctorabout your medical condition or treatment.What is the most important information I shouldknow about Zolpidem Tartrate Sublingual Tablet?Follow the Instructions for Use at the end of thisMedication Guide when you take ZolpidemTartrate Sublingual Tablet. If you do not followthe Instructions for Use, you might be drowsy inthe morning without knowing it.• Only take one Tablet a night, if needed.• Only take Zolpidem Tartrate Sublingual Tablet

if you have at least 4 hours of bedtime left.Zolpidem Tartrate Sublingual Tablet may causeserious side effects, including:• After taking Zolpidem Tartrate Sublingual

Tablet, you may get up out of bed while notbeing fully awake and do an activity that you donot know you are doing. The next morning, youmay not remember that you did anything duringthe night. You have a higher chance for doingthese activities if you drank alcohol that day ortake other medicines that make you sleepy withZolpidem Tartrate Sublingual Tablet. Reportedactivities include:° driving a car ("sleep-driving")° making and eating food° talking on the phone° having sex° sleep-walking

Call your healthcare provider right away if youfind out that you have done any of the aboveactivities after taking Zolpidem TartrateSublingual Tablet.Important:1. Take Zolpidem Tartrate Sublingual Tablet

exactly as prescribed2. Do not take Zolpidem Tartrate Sublingual

Tablet if you: • drank alcohol that day or before bed. • took another medicine to help you sleep. • do not have at least 4 hours of bedtime

remaining.What is Zolpidem Tartrate Sublingual Tablet?Zolpidem Tartrate Sublingual Tablet is asedative-hypnotic (sleep) medicine. ZolpidemTartrate Sublingual Tablet is used in adults for thetreatment of a sleep problem called insomnia.Many people have difficulty returning to sleep afterawakening in the middle of the night. ZolpidemTartrate Sublingual Tablet is designed tospecifically treat this problem.It is not known if Zolpidem Tartrate SublingualTablet is safe and effective in children.Zolpidem Tartrate Sublingual Tablet is a federallycontrolled substance (CIV) because it can beabused or lead to dependence. Keep ZolpidemTartrate Sublingual Tablet in a safe place to preventmisuse and abuse. Selling or giving away ZolpidemTartrate Sublingual Tablet may harm others, and is

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carbonate anhydrous, sodium bicarbonate, naturaland artificial spearmint flavor, aspartame, andmagnesium stearate.Rx onlyThis Medication Guide has been approved by theU.S. Food and Drug Administration.Manufactured by: Manufactured for:Novel Laboratories, Inc. Gavis Pharmaceuticals, LLCSomerset, NJ 08873 Somerset, NJ 08873

Iss. 01/2016

Instructions for UseZolpidem Tartrate (ZOL-pi-dem TAR-trateor zole-PI-dem TAR-trate) Sublingual TabletRead these Instructions for Use before you starttaking Zolpidem Tartrate Sublingual Tablet andeach time you get a refill. There may be newinformation. This information does not take theplace of talking to your healthcare provider aboutyour medical condition or your treatment.What is the most important Information I shouldknow about Zolpidem Tartrate Sublingual Tablet?Follow these Instructions for Use when you takeZolpidem Tartrate Sublingual Tablet. If you do notfollow these instructions, you might be drowsy inthe morning without knowing it.• Only take 1 Tablet a night if needed• Only take Zolpidem Tartrate Sublingual Tablet if

you have at least 4 hours of bedtime leftUsing Zolpidem Tartrate Sublingual Tablet thewrong way can make you drowsy in the morning.Before you go to bed:• Place only 1 Zolpidem Tartrate Sublingual Tablet

pouch by your bed, and have a clock or watchnearby (see Figure A).

• Store all other Zolpidem Tartrate SublingualTablet pouches with your other medicines awayfrom your bedside.

• Only remove the blister from the ZolpidemTartrate Sublingual Tablet pouch when you areready to use it.

• You can either use the Zolpidem TartrateSublingual Tablet Dosing Time Chart (seeFigure B) or the Dosing Time Tool (see FigureC) that comes with Zolpidem Tartrate SublingualTablet to find the latest time during the night youcan take Zolpidem Tartrate Sublingual Tablet.

Zolpidem Tartrate Sublingual Tablet Dosing TimeChart (see Figure B):• You can take Zolpidem Tartrate Sublingual Tablet

if you have at least 4 hours of bedtime left beforeyou must be awake.

• Find the earliest time you have to be up andawake in the column on the left.

• Find the latest time you can take ZolpidemTartrate Sublingual Tablet on the same line in thecolumn on the right.

only 1 puch

Figure A

Zolpidem Tartrate Sublingual Tablet Dosing TimeChart

If you must Take Zolpidem Tartratebe awake by: Sublingual Tablets before:

4 am 12 midnight5 am 1 am6 am 2 am7 am 3 am8 am 4 am9 am 5 am

Figure BZolpidem Tartrate Sublingual Tablet Dosing TimeTool (see Figure C):• Turn the Zolpidem Tartrate Sublingual Tablet

Dosing Time Tool wheel to show the earliest timethat you must be awake under the green arrow.

• Take Zolpidem Tartrate Sublingual Tablet beforethe time under the black arrow.

Figure C

During the night when you take Zolpidem TartrateSublingual Tablet:Step 1. Check the current time and use theZolpidem Tartrate Sublingual Tablet Dosing TimeChart or the Zolpidem Tartrate Sublingual TabletDosing Time Tool to decide if you should takeZolpidem Tartrate Sublingual Tablet.• Only take Zolpidem Tartrate Sublingual Tablet if

you have at least 4 hours of bedtime left beforeyou have to be awake (see Figure B).

Step 2. Remove the blister from the ZolpidemTartrate Sublingual Tablet pouch you placed byyour bed. (see Figure D)

Step 3. Peel off the top layer of paper and pushZolpidem Tartrate Sublingual Tablet from otherside (see Figure E).

If you mustbe awake by:

am am

Zolpidem TartrateSublingual Tablet IV

Zolpidem TartrateSublingual Tablet IV

Take

before:

Turn wheel to show the earliest time that youmust be awake under the green arrow

Take Zolpidem Tartrate Sublingual Tabletbefore the time under the black arrow

Only take Zolpidem Tartrate Sublingual Tabletif you have at least 4 hours of bedtime left.

•

•

To find your latest dosing time:

Figure D

Step 4. Leave the empty Zolpidem TartrateSublingual Tablet pouch where you can see it. Theempty pouch will help remind you that you alreadytook your Zolpidem Tartrate Sublingual Tablet dose(see Figure F).

Step 5. While in bed, place the Zolpidem TartrateSublingual Tablet under your tongue and allow itto break apart completely, then swallow. Do notswallow it whole. (see Figure G)

Step 6. Throw the empty Zolpidem TartrateSublingual Tablet pouch away in the morning.When you wake up in the morning, be sure thatat least 4 hours have passed since you have takenZolpidem Tartrate Sublingual Tablet and you feelfully awake before driving. Do not do dangerousactivities until you know how Zolpidem TartrateSublingual Tablet affects you.This Medication Guide and Instructions for Usehave been approved by the U.S. Food and DrugAdministration.Manufactured by: Manufactured for:Novel Laboratories, Inc. Gavis Pharmaceuticals, LLC400 Campus Drive 400 Campus DriveSomerset, NJ 08873 Somerset, NJ 08873

Iss. 01/2016MG7610000201

Figure E

Figure F

empty pouch

Figure G

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