ZolpiMist is a sedative-hypnotic (sleep) medicine. ZolpiMist is used in adults
for the short-term treatment of a sleep problem called insomnia.

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IMPORTANT SAFETY INFORMATION FOR ZolpiMist

ZolpiMist (zolpidem tartrate) Oral Spray is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

WARNING: COMPLEX SLEEP BEHAVIORS!

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of ZolpiMist. Some of these events may result in serious injuries, including death. Discontinue ZolpiMist immediately if a patient experiences a complex sleep behavior.

IMPORTANT RISK INFORMATION

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:
  • driving a car (“sleep-driving”)
  • making and eating food
  • talking on the phone
  • having sex
  • sleep-walking
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
    • Do not take more ZolpiMist than prescribed.
    • Take ZolpiMist right before you get in bed, not sooner.
  2. Do not take ZolpiMist 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 ZolpiMist
    • 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 ZolpiMist with your other medicines.
    • cannot get a full night sleep
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:
  • trouble falling asleep
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:
  • 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 breastfeeding
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?
  • Take ZolpiMist exactly as prescribed. Do not take more ZolpiMist than prescribed for you.
  • Take ZolpiMist right before you get into bed.
  • Do not take ZolpiMist unless you are able to stay in bed a full night (7-8 hours) before you must be active again.
  • For faster sleep onset, ZolpiMist should NOT be taken with or immediately after a meal.
  • Call your doctor 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 ZolpiMist or overdose, call your doctor or poison control center right away, or get emergency treatment.
What are the possible side effects of ZolpiMist?
Serious side effects of ZolpiMist include:
  • getting out of bed while not being fully awake and doing an activity that you do not know you are doing. (See “What is the most important information I should know about ZolpiMist?”)
  • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
  • memory loss
  • anxiety
  • severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking ZolpiMist.
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:
  • drowsiness
  • dizziness
  • diarrhea
  • “drugged feelings”
  • You may still feel drowsy the next day after taking ZolpiMist. Do not drive or do other dangerous activities after taking ZolpiMist until you feel fully awake.
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.
ADVERSE EVENT REPORTING
To report suspected adverse events or product complaints, please contact Aytu BioPharma at 855-AYTU-BIO; FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.