Uses of Zolpidem Sublingual Tablets:

• It is used to treat sleep problems.

What do I need to tell my doctor BEFORE I take Zolpidem Sublingual Tablets?

• If you have an allergy to zolpidem or any other part of this medicine (zolpidem sublingual tablets).
• If you are allergic to this medicine (zolpidem sublingual tablets); any part of this medicine (zolpidem sublingual tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.
• If you are taking any other drugs that can make you sleepy. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you have taken this medicine (zolpidem sublingual tablets) or a drug like this one in the past and have done any tasks or actions while not fully awake.
• If you are taking any of these drugs: Rifampin or St. John's wort.

This is not a list of all drugs or health problems that interact with this medicine (zolpidem sublingual tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (zolpidem sublingual tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Zolpidem Sublingual Tablets?

• Tell all of your health care providers that you take this medicine (zolpidem sublingual tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert after you take this medicine (zolpidem sublingual tablets). You may still feel sleepy the day after you take this medicine (zolpidem sublingual tablets). Avoid these tasks or actions until you feel fully awake.
• This medicine may be habit-forming with long-term use.
• When sleep drugs are used nightly for more than a few weeks, they may not work as well to help sleep problems. This is known as tolerance. Only use sleep drugs for a short time. If sleep problems last, call the doctor.
• Do not take naps.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Avoid alcohol while taking this medicine (zolpidem sublingual tablets). Do not take this medicine (zolpidem sublingual tablets) if you drank alcohol that evening or before bed.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• This medicine may cause sleepiness or lower alertness. This may lead to falls and injuries that may be very bad. Very bad injuries like broken hips and bleeding in the brain have happened. Talk with the doctor.
• If you are a woman, use this medicine (zolpidem sublingual tablets) with care. You could have more side effects.
• If you are 60 or older, use this medicine (zolpidem sublingual tablets) with care. You could have more side effects.
• This medicine is not approved for use in children. The chance of side effects like dizziness and hallucinations may be raised in children. However, your child's doctor may decide the benefits of taking this medicine (zolpidem sublingual tablets) may outweigh the risks. Talk with the doctor if you have questions about giving this medicine (zolpidem sublingual tablets) to your child.
• If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• Taking this medicine (zolpidem sublingual tablets) in the third trimester of pregnancy may lead to some health problems in the newborn. Talk with the doctor.

How is this medicine (Zolpidem Sublingual Tablets) best taken?

Use this medicine (zolpidem sublingual tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• If you still have trouble sleeping after 7 to 10 days, call your doctor.
• Take this medicine (zolpidem sublingual tablets) at bedtime.
• Take this medicine (zolpidem sublingual tablets) only 1 time per night.
• Take on an empty stomach.
• Do not take with or right after a meal.
• Be sure your hands are dry before you touch this medicine (zolpidem sublingual tablets).
• Place under tongue and let dissolve all the way. Do not chew, suck or swallow tablet.
• Do not eat, drink, or smoke while the tablet is dissolving.
• Take only as needed if you wake up in the middle of the night and have trouble going back to sleep. Only take a dose if you have 4 or more hours of bedtime left. Do not take more than 1 dose per night.
• Only keep 1 pouch with this medicine (zolpidem sublingual tablets) in it at your bedside. Store all other pouches away from your bedside. Do not remove the drug from the pouch until you are ready to take a dose. After you take this medicine (zolpidem sublingual tablets), leave the empty pouch where you can see it. This will help remind you that you have taken your dose.

What do I do if I miss a dose?

• If you take this medicine (zolpidem sublingual tablets) on a regular basis, take a missed dose as soon as you think about it.
• If you will not be able to get 4 or more hours of sleep after taking the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Do not take more than 1 dose of this medicine (zolpidem sublingual tablets) in the same day.
• Many times this medicine (zolpidem sublingual tablets) is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• New or worse behavior or mood changes like depression or thoughts of suicide.
• Hallucinations (seeing or hearing things that are not there).
• Feeling confused.
• Not thinking clearly.
• Trouble breathing, slow breathing, or shallow breathing.
• Change in balance.
• Change in eyesight.
• Memory problems or loss.
• Feeling very tired or weak.

What are some other side effects of Zolpidem Sublingual Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy the next day.
• Headache.
• Upset stomach.
• Diarrhea.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Zolpidem Sublingual Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (zolpidem sublingual tablets) is refilled. If you have any questions about this medicine (zolpidem sublingual tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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