ZOLPIMIST- zolpidem tartrate spray, metered
Aytu BioPharma, Inc.
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MEDICATION GUIDE
ZOLPIMIST Oral Spray (C-IV)
( zolpidem tartrate) Spray, Metered for Oral Use
Read the Medication Guide that comes with ZOLPIMIST 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 ZOLPIMIST?
Complex sleep behaviors that have caused serious injury and death. After taking ZOLPIMIST, 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 happen whether or not you drink alcohol or take other medicines that make you sleepy with ZOLPIMIST. Reported activities include:
Stop taking Zolpimist and call your doctor right away if you find out that you have done any of the above activities after taking ZOLPIMIST.
Important:
1. Take ZOLPIMIST exactly as prescribed
2. Do not take ZOLPIMIST if you:
What is ZOLPIMIST?
ZOLPIMIST is a sedative-hypnotic (sleep) medicine. ZOLPIMIST is used in adults for the short-term treatment of a sleep problem called insomnia. Symptoms of insomnia include:
ZOLPIMIST is not for children.
ZOLPIMIST is a federally controlled substance (C-IV) because it can be abused and lead to dependence. Keep ZOLPIMIST in a safe place to prevent misuse and abuse. Selling or giving away ZOLPIMIST 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 ZOLPIMIST? Do not take ZOLPIMIST if you have had an allergic reaction to zolpidem (Ambien, Ambien CR, ZOLPIMIST). Some signs of allergic reaction may be swelling of the face, a feeling of the throat closing, or difficulty breathing shortly after taking Zolpidem.
See the end of this Medication Guide for a complete list of ingredients in ZOLPIMIST.
ZOLPIMIST may not be right for you. Before starting ZOLPIMIST, tell your doctor about all of your health conditions, including if you:
Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take ZOLPIMIST 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 ZOLPIMIST?
What are the possible side effects of ZOLPIMIST?
Serious side effects of ZOLPIMIST 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 ZOLPIMIST.
The most common side effects of ZOLPIMIST are:
After you stop taking a sleep medicine, you may have symptoms for 1 or 2 days such as: tiredness, trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain.
These are not all the side effects of ZOLPIMIST. 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.
Keep ZOLPIMIST and all medicines out of reach of children.
General Information about ZOLPIMIST
This Medication Guide summarizes the most important information about ZOLPIMIST. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZOLPIMIST that is written for healthcare professionals. For more information about ZOLPIMIST, call 1-855-298-8246.
What are the ingredients in ZOLPIMIST?
Active Ingredient: Zolpidem tartrate
Inactive Ingredients: artificial cherry flavor, benzoic acid, citric acid monohydrate, hydrochloric acid, neotame, propylene glycol, and purified water.
Rx Only
Revised August 2019
This Medication Guide has been approved by U.S. Food and Drug Administration.
Aytu BioScience, Inc.
Englewood, CO 80112