ZOLPIDEM TARTRATE- zolpidem tartrate tablet
Novel Laboratories, Inc.
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Zolpidem Tartrate (ZOL-pi-dem TAR-trate or zole-PI-dem TAR-trate) Sublingual Tablet CIV
Phenylalanine is a component of aspartame. Each 3.5 mg and 1.75 mg Zolpidem Tartarate Sublingual Tablets contains 4.48 mg and 2.24 mg of phenylalanine.
Read the Medication Guide that comes with Zolpidem Tartrate Sublingual Tablets 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 doctor about your medical condition or treatment.
What is the most important information I should know about Zolpidem Tartrate Sublingual Tablet?
Follow the Instructions for Use at the end of this Medication Guide when you take Zolpidem Tartrate Sublingual Tablet. If you do not follow the Instructions for Use, you might be drowsy in the morning without knowing it.
Zolpidem Tartrate Sublingual Tablet may cause serious side effects, including:
You have a higher chance for doing these activities if you drank alcohol that day or take other medicines that make you sleepy with Zolpidem Tartrate Sublingual Tablet. Reported activities include:
Call your healthcare provider right away if you find out that you have done any of the above activities after taking Zolpidem Tartrate Sublingual Tablet.
Important:
What is Zolpidem Tartrate Sublingual Tablet?
Zolpidem Tartrate Sublingual Tablet is a sedative-hypnotic (sleep) medicine. Zolpidem Tartrate Sublingual Tablet is used in adults for the treatment of a sleep problem called insomnia. Many people have difficulty returning to sleep after awakening in the middle of the night. Zolpidem Tartrate Sublingual Tablet is designed to specifically treat this problem.
It is not known if Zolpidem Tartrate Sublingual Tablet is safe and effective in children.
Zolpidem Tartrate Sublingual Tablet is a federally controlled substance (CIV) because it can be abused or lead to dependence. Keep Zolpidem Tartrate Sublingual Tablet in a safe place to prevent misuse and abuse. Selling or giving away Zolpidem Tartrate Sublingual Tablet may harm others, and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines, or street drugs.
Who should not take Zolpidem Tartrate Sublingual Tablet?
Symptoms of a serious allergic reaction to Zolpidem Tartrate Sublingual Tablet can include:
Zolpidem Tartrate Sublingual Tablet may not be right for you. Before starting Zolpidem Tartrate Sublingual Tablet, 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 with each other, sometimes causing serious side effects. Your doctor will tell you if you can take Zolpidem Tartrate Sublingual Tablet with your other medicines.
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 Zolpidem Tartrate Sublingual Tablet?
What are the possible side effects of Zolpidem Tartrate Sublingual Tablet?
Zolpidem Tartrate Sublingual Tablet may cause serious side effects, including:
Call your health care provider right away if you have any of the above side effects or any other side effects that worry you while using Zolpidem Tartrate Sublingual Tablet.
The most common side effects of Zolpidem Tartrate Sublingual Tablet are:
Even if you follow the Instructions for Use, you may still feel drowsy in the morning after taking Zolpidem Tartrate Sublingual Tablet. Do not drive or do other dangerous activities after taking Zolpidem Tartrate Sublingual Tablet until you are fully awake.
These are not all the side effects of Zolpidem Tartrate Sublingual Tablet. Ask your health care provider or pharmacist for more information.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store Zolpidem Tartrate Sublingual Tablet?
Keep Zolpidem Tartrate Sublingual Tablet and all medicines out of reach of children.
General Information about Zolpidem Tartrate Sublingual Tablet
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Zolpidem Tartrate Sublingual Tablet for a condition for which it was not prescribed. Do not give Zolpidem Tartrate Sublingual Tablet to other people, even if you think 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 Zolpidem Tartrate Sublingual Tablet. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Zolpidem Tartrate Sublingual Tablet that is written for healthcare professionals.
What are the ingredients in Zolpidem Tartrate Sublingual Tablet?
Active Ingredient: Zolpidem tartrate
Inactive Ingredients: Each Zolpidem Tartrate Sublingual Tablet includes the following inactive ingredients: Crospovidone, Povidone, Mannitol, Polyvinylacetate, colloidal silicon dioxide, sodium carbonate anhydrous, sodium bicarbonate, natural and artificial spearmint flavor, aspartame, and magnesium stearate.
Rx only
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873
Rev. 06/2016
Zolpidem Tartrate (ZOL-pi-dem TAR-trate or zole-PI-dem TAR-trate) Sublingual Tablet CIV
Read these Instructions for Use before you start taking Zolpidem Tartrate Sublingual Tablet and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important Information I should know about Zolpidem Tartrate Sublingual Tablet?
Follow these Instructions for Use when you take Zolpidem Tartrate Sublingual Tablet. If you do not follow these instructions, you might be drowsy in the morning without knowing it.
Using Zolpidem Tartrate Sublingual Tablet the wrong way can make you drowsy in the morning.
Before you go to bed:
Zolpidem Tartrate Sublingual Tablet Dosing Time Chart (see Figure B):
Zolpidem Tartrate Sublingual Tablet Dosing Time Tool (see Figure C):
During the night when you take Zolpidem Tartrate Sublingual Tablet:
Step 1. Check the current time and use the Zolpidem Tartrate Sublingual Tablet Dosing Time Chart or the Zolpidem Tartrate Sublingual Tablet Dosing Time Tool to decide if you should take Zolpidem Tartrate Sublingual Tablet.
Step 2. Remove the blister from the Zolpidem Tartrate Sublingual Tablet pouch you placed by your bed (see Figure D).
Step 3. Cut blister with scissors at dotted line and take the Zolpidem Tartrate Sublingual Tablet out. (see Figure E).
Step 4. Leave the empty Zolpidem Tartrate Sublingual Tablet pouch where you can see it. The empty pouch will help remind you that you already took your Zolpidem Tartrate Sublingual Tablet dose (see Figure F).
Step 5. While in bed, place the Zolpidem Tartrate Sublingual Tablet under your tongue and allow it to break apart completely, then swallow. Do not swallow it whole. (see Figure G)
Step 6. Throw the empty Zolpidem Tartrate Sublingual Tablet pouch away in the morning.
When you wake up in the morning, be sure that at least 4 hours have passed since you have taken Zolpidem Tartrate Sublingual Tablet and you feel fully awake before driving. Do not do dangerous activities until you know how Zolpidem Tartrate Sublingual Tablet affects you.
This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novel Laboratories, Inc.
400 Campus Drive, Somerset, NJ 08873
Rev. 06/2016