Zolpidem Tartrate Oral tablet

What is this medicine?

ZOLPIDEM (zole PI dem) is used to treat insomnia. This medicine helps you to fall asleep and sleep through the night.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• depression

• history of drug abuse or addiction

• if you often drink alcohol

• liver disease

• lung or breathing disease

• myasthenia gravis

• sleep apnea

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to zolpidem, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. It is better to take this medicine on an empty stomach and only when you are ready for bed. Do not take your medicine more often than directed. If you have been taking this medicine for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your doctor or health care professional may want to gradually reduce the dose. Do not stop taking this medicine on your own. Always follow your doctor or health care professional's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine should only be taken immediately before going to sleep. Do not take double or extra doses.

What may interact with this medicine?

• herbal medicines like kava kava, melatonin, St. John's wort and valerian

• medicines for fungal infections like ketoconazole, fluconazole, or itraconazole

• medicines for treating depression or other mental problems

• other medicines given for sleep

• some medicines for Parkinson' s disease or other movement disorders

• some medicines used to treat HIV infection or AIDS, like ritonavir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. When sleep medicines are used every night for more than a few weeks, they may stop working. Talk to your doctor if you still have trouble sleeping.

After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. After you wake up the next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Let your health care provider know right away if you experience this type of effect. Do not take this medicine if you have used alcohol that evening or before bed or taken another medicine for sleep since your risk of doing these sleep-related activities will be increased.

Wait for at least 8 hours after you take a dose before driving or doing other activities that require full mental alertness. Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. Do not stand or sit up quickly after taking this medicine, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.

After you stop taking this medicine, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• depressed mood or other changes in moods or emotions

• feeling faint or lightheaded, falls

• hallucinations

• loss of balance or coordination

• loss of memory

• restlessness, excitability, or feelings of anxiety or agitation

• suicidal thoughts

• unusual activities while asleep like driving, eating, making phone calls, or sexual activity

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• drowsiness the day after you take this medicine

• headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

Zolpidem Tartrate Oral tablet, biphasic release

What is this medicine?

ZOLPIDEM (zole PI dem) is used to treat insomnia. This medicine helps you to fall asleep and sleep through the night.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• depression

• history of drug abuse or addiction

• if you often drink alcohol

• liver disease

• lung or breathing disease

• myasthenia gravis

• sleep apnea

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to zolpidem, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not crush, split, or chew the tablet before swallowing. It is better to take this medicine on an empty stomach and only when you are ready for bed. Do not take your medicine more often than directed. If you have been taking this medicine for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your doctor or health care professional may want to gradually reduce the dose. Do not stop taking this medicine on your own. Always follow your doctor or health care professional's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine should only be taken immediately before going to sleep. Do not take double or extra doses.

What may interact with this medicine?

• herbal medicines like kava kava, melatonin, St. John's wort and valerian

• medicines for fungal infections like ketoconazole, fluconazole, or itraconazole

• medicines for treating depression or other mental problems

• other medicines given for sleep

• some medicines for Parkinson' s disease or other movement disorders

• some medicines used to treat HIV infection or AIDS, like ritonavir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. When sleep medicines are used every night for more than a few weeks, they may stop working. Talk to your doctor if your insomnia worsens or is not better within 7 to 10 days.

After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. After you wake up the next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Let your health care provider know right away if you experience this type of effect. Do not take this medicine if you have used alcohol that evening or before bed or taken another medicine for sleep since your risk of doing these sleep-related activities will be increased.

Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. Do not drive, use machinery, or do anything that needs mental alertness the day after you take this medicine. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your moods or behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.

After you stop taking this medicine, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• depressed mood or other changes in moods or emotions

• feeling faint or lightheaded, falls

• hallucinations

• loss of balance or coordination

• loss of memory

• restlessness, excitability, or feelings of anxiety or agitation

• suicidal thoughts

• unusual activities while asleep like driving, eating, making phone calls, or sexual activity

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• drowsiness the day after you take this medicine

• headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at controlled room temperature between 15 and 25 degrees C (59 and 77 degrees F). Throw away any unused medicine after the expiration date.

Zolpidem Tartrate Oromucosal spray

What is this medicine?

ZOLPIDEM (zole PI dem) is used to treat insomnia. This medicine helps you to fall asleep and sleep through the night.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• depression

• history of drug abuse or addiction

• if you often drink alcohol

• liver disease

• lung or breathing disease

• myasthenia gravis

• sleep apnea

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to zolpidem, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by spraying in the mouth over the tongue. Follow the directions on the prescription label. It is better to take this medicine on an empty stomach and only when you are ready for bed. Do not take your medicine more often than directed. If you have been taking this medicine for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your doctor or health care professional may want to gradually reduce the dose. Do not stop taking this medicine on your own. Always follow your doctor or health care professional's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine should only be taken immediately before going to sleep. Do not take double or extra doses.

What may interact with this medicine?

• herbal medicines like kava kava, melatonin, St. John's wort and valerian

• medicines for fungal infections like ketoconazole, fluconazole, or itraconazole

• medicines for treating depression or other mental problems

• other medicines given for sleep

• some medicines for Parkinson' s disease or other movement disorders

• some medicines used to treat HIV infection or AIDS, like ritonavir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. When sleep medicines are used every night for more than a few weeks, they may stop working. Talk to your doctor if you still have trouble sleeping.

After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. After you wake up the next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Let your health care provider know right away if you experience this type of effect. Do not take this medicine if you have used alcohol that evening or before bed or taken another medicine for sleep since your risk of doing these sleep-related activities will be increased.

Wait for at least 8 hours after you take a dose before driving or doing other activities that require full mental alertness. Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. Do not stand or sit up quickly after taking this medicine, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your moods or behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.

After you stop taking this medicine, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• depressed mood or other changes in moods or emotions

• feeling faint or lightheaded, falls

• hallucinations

• loss of balance or coordination

• loss of memory

• restlessness, excitability, or feelings of anxiety or agitation

• suicidal thoughts

• unusual activities while asleep like driving, eating, making phone calls, or sexual activity

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• drowsiness the day after you take this medicine

• headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep the container upright. Do not freeze. Throw away any unused medicine after 60 sprays have been used. Throw away any unused medicine after the expiration date.

Zolpidem Tartrate Sublingual tablet

What is this medicine?

ZOLPIDEM (zole PI dem) is used to treat insomnia. Edluar is for use when you have trouble falling asleep when you first go to bed. Intermezzo is for use when you have trouble returning to sleep after waking in the middle of the night.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• depression

• history of drug abuse or addiction

• if you often drink alcohol

• liver disease

• lung or breathing disease

• myasthenia gravis

• sleep apnea

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to zolpidem, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Place this medicine under your tongue and let it dissolve. Do not swallow it or take it with water. Follow the directions on the prescription label. Take this medicine on an empty stomach. Do not take your medicine more often than directed. If you have been taking this medicine for several weeks and suddenly stop taking it, you may get unpleasant withdrawal symptoms. Your doctor or health care professional may want to slowly lower the dose. Do not stop taking this medicine on your own. Always follow your doctor or health care professional's advice.

Edluar brand: This medicine will help you fall asleep. You will only take the medicine right before you get into bed. Take only when you are able to stay in bed a full night (7 to 8 hours) before being active again.

Intermezzo brand: This medicine is used to help you return to sleep after waking in the middle of the night. Only take it if you have at least 4 hours of bedtime remaining. Place a single Intermezzo pouch by your bed. Store all other unopened Intermezzo pouches and other medicines away from your bedside. Only open the Intermezzo pouch when you are ready to use it. If needed, use one of the dosing time tools that come with your prescription to find the latest time of night you can take your dose. After taking the dose, leave the empty medicine pouch where you can see it to help remind you that the dose has already been taken. Throw the empty pouch away in the morning.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This medicine should only be taken immediately before going to sleep (Edluar brand) or when you have trouble returning to sleep after waking in the middle of the night (Intermezzo brand). You will only take one dose per night. Do not take double or extra doses.

What may interact with this medicine?

• herbal medicines like kava kava, melatonin, St. John's wort, and valerian

• medicines for fungal infections like ketoconazole, fluconazole, or itraconazole

• medicines for treating depression or other mental illnesses

• other medicines given for sleep

• some medicines for Parkinson's disease or other movement disorders

• some medicines used to treat HIV infection or AIDS, like ritonavir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. Talk to your doctor if your insomnia worsens or is not better within 7 to 10 days.

After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. After you wake up the next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Let your health care provider know right away if you experience this type of effect. Do not take this medicine if you have used alcohol that evening or before bed or taken another medicine for sleep since your risk of doing these sleep-related activities will be increased.

When using this medicine for help with trouble falling asleep (Edluar tablets), do not take it unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. When using this medicine for middle-of-the-night awakening (Intermezzo tablets), do not take it with less than 4 hours of bedtime remaining. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Do not stand or sit up quickly after taking this medicine, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your moods or behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.

After you stop taking this medicine, you may have trouble falling asleep. This is called rebound insomnia. This problem usually goes away on its own after 1 or 2 nights.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• confusion

• depressed mood or other changes in moods or emotions

• feeling faint or lightheaded, falls

• hallucinations

• loss of balance or coordination

• loss of memory

• numbness or tingling of the tongue

• restlessness, excitability, or feelings of anxiety or agitation

• suicidal thoughts

• unusual activities while asleep like driving, eating, making phone calls, or sexual activity

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dizziness

• drowsiness the day after you take this medicine

• headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Throw away any unused medicine after the expiration date.