MEDICATION GUIDE

Zolpimist (zolpidem tartrate) Oral Spray (Zol-pi-mist) [zolpidem tartrate oral spray (CIV)]

Read the Medication Guide that comes with Zolpimist (zolpidem tartrate) Oral Spray 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 Zolpimist (zolpidem tartrate) Oral Spray?

• Do not take more Zolpimist (zolpidem tartrate) Oral Spray than prescribed.
• Do not take Zolpimist (zolpidem tartrate) Oral Spray unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.

Take Zolpimist (zolpidem tartrate) Oral Spray right before you get in bed, not sooner. Zolpimist (zolpidem tartrate) Oral Spray may cause serious side effects including:

• After taking Zolpimist (zolpidem tartrate) Oral Spray, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Zolpimist (zolpidem tartrate) Oral Spray. Reported activities 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 you find out that you have done any of the above activities after taking Zolpimist (zolpidem tartrate) Oral Spray. Do not take Zolpimist (zolpidem tartrate) Oral Spray if you:

• drank alcohol that evening or before bed
• took another medicine to help you sleep

What is Zolpimist (zolpidem tartrate) Oral Spray?

Zolpimist (zolpidem tartrate) Oral Spray is a sedative-hypnotic (sleep) medicine. Zolpimist (zolpidem tartrate) Oral Spray is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

It is not known if Zolpimist (zolpidem tartrate) Oral Spray is safe and effective in children under the age of 18 years.

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

Who should not take Zolpimist (zolpidem tartrate) Oral Spray?

• Do not take Zolpimist (zolpidem tartrate) Oral Spray if you are allergic to zolpidem or any other ingredients in Zolpimist (zolpidem tartrate) Oral Spray. See the end of this Medication Guide for a complete list of ingredients in Zolpimist (zolpidem tartrate) Oral Spray.
• Do not take Zolpimist (zolpidem tartrate) Oral Spray if you have had an allergic reaction to zolpidem, such as Ambien, Ambien CR, Edluar, or Intermezzo. Symptoms of a serious allergic reaction to zolpidem can include: swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

What should I tell my healthcare provider before taking Zolpimist (zolpidem tartrate) Oral Spray?

Zolpimist (zolpidem tartrate) Oral Spray may not be right for you. Before starting Zolpimist (zolpidem tartrate) Oral Spray, 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 kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant. It is not known if Zolpimist (zolpidem tartrate) Oral Spray will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Zolpimist (zolpidem tartrate) Oral Spray can pass into your breast milk. It is not known if Zolpimist (zolpidem tartrate) Oral Spray will harm your baby. Talk to your healthcare provider about the best way to feed your baby while you take Zolpimist (zolpidem tartrate) Oral Spray .

Tell your healthcare provider 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 (zolpidem tartrate) Oral Spray 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 Zolpimist (zolpidem tartrate) Oral Spray?

• See " What is the most important information I should know about Zolpimist (zolpidem tartrate) Oral Spray?"
• Take Zolpimist (zolpidem tartrate) Oral Spray exactly as prescribed. Only take 1 Zolpimist (zolpidem tartrate) Oral Spray dose a night if needed.
• Do not take Zolpimist (zolpidem tartrate) Oral Spray if you drank alcohol that evening or before bed.
• You should not take Zolpimist (zolpidem tartrate) Oral Spray with or right after a meal. Zolpimist (zolpidem tartrate) Oral Spray may help you fall asleep faster if you take it on an empty stomach.
• 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 Zolpimist (zolpidem tartrate) Oral Spray or overdose, get emergency treatment.

What are the possible side effects of Zolpimist (zolpidem tartrate) Oral Spray? Zolpimist (zolpidem tartrate) Oral Spray may cause serious side effects, including:

• 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 (zolpidem tartrate) Oral Spray?"
• 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, and trouble breathing. Get emergency medical help if you get these symptoms after taking Zolpimist (zolpidem tartrate) Oral Spray.

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 Zolpimist (zolpidem tartrate) Oral Spray.

The most common side effects of Zolpimist (zolpidem tartrate) Oral Spray are:

• drowsiness
• dizziness
• diarrhea
• grogginess or feeling as if you have been drugged

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

trouble sleeping nausea flushing lightheadedness uncontrolled crying

vomiting stomach cramps panic attack nervousness stomach area pain

These are not all the side effects of Zolpimist (zolpidem tartrate) Oral Spray. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or MAGNA at 1-888206-5525.

How should I store Zolpimist (zolpidem tartrate) Oral Spray?

• Store Zolpimist (zolpidem tartrate) Oral Spray in an upright position between 59 °F to 86 °F (15 °C to 30 °C).
• Do not freeze.
• Avoid prolonged product exposure above 86 °F (30 °C).
• The child-resistant container should be thrown away when the 30 or 60 sprays have been used, depending upon the package size (4.5 mL; 30 sprays or 7.7 mL; 60 sprays).

Keep Zolpimist (zolpidem tartrate) Oral Spray and all medicines out of reach of children.

General information about safe and effective use of Zolpimist (zolpidem tartrate) Oral Spray

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide

Do not use Zolpimist (zolpidem tartrate) Oral Spray for a condition for which it was not prescribed.

Do not share Zolpimist (zolpidem tartrate) Oral Spray with other people, even if they may 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 Zolpimist (zolpidem tartrate) Oral Spray. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Zolpimist (zolpidem tartrate) Oral Spray that is written for healthcare professionals.

For more information about Zolpimist (zolpidem tartrate) Oral Spray call 1-888-206-5525

What are the ingredients in Zolpimist (zolpidem tartrate) Oral Spray?

Active ingredient: Zolpidem tartrate

Inactive ingredients: artificial cherry flavor, benzoic acid, citric acid monohydrate, hydrochloric acid, neotame, propylene glycol, and purified water.

This Medication Guide has been approved by U.S. Food and Drug Administration.

MAGNA Pharmaceuticals
10801 Electron Drive, Suite 100
Louisville KY 40299

January, 2016