Ambien (zolpidem) Tabs 10mg
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Product ID : ambien
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Description
AMBIEN (zolpidem tartrate) 10mg Tablets
Patient Education - English
- Generic Name: zolpidem
- Pronounced: zole PI dem
- Brand Names: Ambien, Ambien CR, Edluar
What is the most important information I should know about zolpidem?
Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Zolpidem will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.
Zolpidem can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Do not drink alcohol while you are taking zolpidem. It can increase some of the side effects of zolpidem, including drowsiness.
Zolpidem may be habit-forming and should be used only by the person it was prescribed for. Zolpidem should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.
What is zolpidem?
Zolpidem is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).
Zolpidem is used to treat insomnia. The immediate-release form of zolpidem is Ambien, which is used to help you fall asleep. The extended-release form of zolpidem is Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.
Your doctor will determine which form of zolpidem is best for you.
Zolpidem may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking zolpidem?
Zolpidem will make you fall asleep. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.
Do not use this medication if you are allergic to zolpidem. Zolpidem tablets may contain lactose. Use caution if you are sensitive to lactose.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take zolpidem:
- kidney disease;
- liver disease;
- lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);
- sleep apnea (breathing stops during sleep);
- myasthenia gravis;
- a history of depression, mental illness, or suicidal thoughts; or
- a history of drug or alcohol addiction.
FDA pregnancy category C. It is not known whether zolpidem is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.
Zolpidem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
The sedative effects of zolpidem may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking zolpidem.
Do not give this medicine to anyone younger than 18 years of age.
It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.
How should I take zolpidem?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Zolpidem comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Take zolpidem only if you are able to get a full night's sleep before you must be active again. Never take this medication during your normal waking hours, unless you have a full 7 to 8 hours to dedicate to sleeping.
Take zolpidem with a full glass of water. Avoid taking Ambien CR with or just after a meal or it may take longer for you to fall asleep.
Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice.
You may have withdrawal symptoms if you stop taking zolpidem after taking it over several days in a row. Do not stop taking zolpidem suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.
Withdrawal symptoms include behavior changes, stomach pain, muscle cramps, nausea, vomiting, sweating, anxiety, panic, tremors, and seizure (convulsions). Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.
Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.
Do not swallow the Edluar tablet whole. Place it under your tongue and allow it to dissolve in your mouth without water.
Store zolpidem at room temperature away from moisture and heat.
What happens if I miss a dose?
Since zolpidem is usually taken as needed, you may not be on a dosing schedule. Never take this medication if you do not have a full 7 to 8 hours to sleep before being active again. Do not take extra medicine to make up a missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of zolpidem can be fatal when it is taken together with other medications that can cause drowsiness.
Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.
What should I avoid while taking zolpidem?
Zolpidem can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how this medication will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.
Do not drink alcohol while you are taking zolpidem. It can increase some of the side effects of zolpidem, including drowsiness.
What are the possible side effects of zolpidem?
Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using zolpidem and call your doctor at once if you have any of these serious side effects:
- depressed mood, thoughts of hurting yourself;
- unusual thoughts, risk-taking behavior, decreased inhibitions, no fear of danger;
- anxiety, aggression, feeling restless or agitated;
- hallucinations, confusion, changes in personality.
Less serious side effects may include:
- daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
- lack of coordination;
- amnesia, forgetfulness;
- vivid or abnormal dreams;
- nausea, constipation;
- stuffy nose, sore throat;
- headache, muscle pain; or
- blurred vision.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
What other drugs will affect zolpidem?
You may need a lower dose of zolpidem if you take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are currently taking any of these medications.
Before taking zolpidem, tell your doctor about all other medications you use, especially:
- chlorpromazine (Thorazine);
- itraconazole (Sporanox), ketoconazole (Nizoral);
- rifampin (Rifadin, Rimactane, Rifater); or
- antidepressants such as imipramine (Janimine, Tofranil), or sertraline (Zoloft).
This list is not complete and there may be other drugs that can interact with zolpidem. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about zolpidem.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Pill Pictures
 Ambien (zolpidem) 10 mg
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 Ambien (zolpidem) 5 mg
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GENERI AMBIEN (zolpidem) tablets may be different in color, texture and shape.
AMBIEN
Commonly used brand name(s):
In the U.S. Ambien, Ambien CR, Stilnoct, Durnit, Zolpim, Zolpidem
Available Dosage Forms:
- Tablet, Extended Release
- Tablet
Uses For Ambien
Zolpidem belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Zolpidem is used to treat insomnia (trouble in sleeping). Zolpidem helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.
This medicine is available only with your doctor's prescription.
Therapeutic Class: Nonbarbiturate Hypnotic
Before Using Ambien
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Sleep medicines may cause a special type of memory loss or "amnesia". When this occurs, a person does not remember what has happened during the several hours between use of the medicine and the time when its effects wear off. This is usually not a problem since most people fall asleep after taking the medicine. In most instances, memory problems can be avoided by taking zolpidem only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of zolpidem in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zolpidem in the elderly. However, confusion and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zolpidem. Elderly patients may require a lower dose to help reduce unwanted effects.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Using this medicine with any of th e following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Fospropofol
- Tapentadol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Bupropion
- Desipramine
- Ketoconazole
- R ifampin
- Sertraline
- Venlafaxine
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, or history of or
- Drug abuse or dependence, or history of—Dependence on zolpidem may develop.
- Emphysema, asthma, bronchitis, or other chronic lung disease or
- Mental depression, or history of or
- Myasthenia gravis (severe muscle weakness) or
- Sleep apnea (temporary stopping of breathing during sleep)—Use with caution. Zolpidem may make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. Higher blood levels of zolpidem may result, increasing the chance of side effects.
Proper Use of zolpidem
This section provides information on the proper use of a number of products that contain zolpidem. It may not be specific to Ambien. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).
Take zolpidem just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.
You should swallow the extended-release tablets whole. Do not crush or chew them.
Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.
Zolpidem should not be taken with food or right after a meal. It will work faster if you take it on an empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
If you are using the oral spray for the first time, it must be primed by spraying it for 5 times in a safe direction away from your face and other people. If the oral spray has not been used for 14 days, it must be primed again with 1 spray.
To use the oral spray:
- Pull the child-resistant cap to separate it from the base.
- Remove the clear protective cap from the pump.
- Hold the container upright with the black spray opening pointed directly into your mouth.
- Fully press down on the pump to make sure that a full dose (5 mg) of is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed by your doctor, a second spray should be given.
- Put the clear protective cap back over the pump after each use.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For the treatment of insomnia (trouble in sleeping):
- For oral dosage form (tablets):
- Adults—10 milligrams (mg) once a day at bedtime.
- Older adults—5 mg once a day at bedtime.
- Children—Use and dose must be determined by the doctor.
- For oral dosage form (extended-release [long-acting] tablets):
- Adults—12.5 milligrams (mg) once a day at bedtime.
- Older adults—6.25 mg once a day at bedtime.
- Children—Use and dose must be determined by the doctor.
- For oral dosage form (oral spray):
- Adults—10 milligrams (mg) or 2 sprays into the mouth at bedtime.
- Older adults—5 milligrams (mg) or 1 spray into the mouth at bedtime.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Throw the child-resistant container of the oral spray when the 60 sprays have already been used.
Precautions While Using Ambien
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
If you think you need to take zolpidem for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zolpidem is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Also, this medicine may cause double vision or other vision problems. Make sure you know how you react to zolpidem before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.
If you develop any unusual and strange thoughts or behavior while you are taking zolpidem, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.
This medicine may cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.
If you will be taking zolpidem for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.
After taking zolpidem for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zolpidem or taking alcohol or other CNS depressants with zolpidem may lead to breathing problems and unconsciousness. Some signs of an overdose are severe drowsiness, severe nausea or vomiting, staggering, and troubled breathing.
Zolpidem may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching; hives; hoarseness; trouble breathing or swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
Ambien Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common- Clumsiness or unsteadiness
- confusion
- mental depression
- Dizziness, lightheadedness, or fainting
- falling
- fast heartbeat
- hallucinations (seeing, hearing, or feeling things that are not there)
- skin rash
- swelling of the face
- trouble with sleeping
- unusual excitement, nervousness, or irritability
- wheezing or difficulty with breathing
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose- Clumsiness or unsteadiness (severe)
- dizziness (severe)
- double vision or other vision problems
- drowsiness (severe)
- nausea (severe)
- slow heartbeat
- troubled breathing
- vomiting (severe)
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common- Sleepiness or unusual drowsiness
- Abdominal or stomach pain
- abnormal or decreased touch sensation
- abnormal sensation of movement
- appetite disorder
- balance disorder
- binge eating
- bladder pain
- bloody or cloudy urine
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in hearing
- chest discomfort
- chills
- confusion about identity, place, and time
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- daytime drowsiness
- diarrhea
- difficult, burning, or painful urination
- difficulty with moving
- difficulty with swallowing
- discouragement
- double vision or other vision problems
- drugged feelings
- dryness of mouth
- ear drainage
- earache
- eye redness
- false or unusual sense of well-being
- fear
- feeling of unreality
- feeling sad or empty
- fever
- flatulence
- frequent bowel movements
- frequent urge to urinate
- general feeling of discomfort or illness
- generalized slowing of mental and physical activity
- headache
- hearing loss
- heartburn
- hives or welts
- itching ears
- joint pain
- lack of appetite
- lack of feeling or emotion
- lack or loss of self-control
- lack or loss of strength
- longer or heavier menstrual periods
- loss of balance
- loss of interest or pleasure
- memory problems
- mood swings
- muscle aches, cramping, pain, or stiffness
- nausea
- nervousness
- nightmares or unusual dreams
- pain in joints
- redness of the skin
- redness or soreness of the throat
- sense of detachment from self or body
- shortness of breath or troubled breathing
- skin rash
- skin wrinkling
- sneezing
- sore throat
- stress symptoms
- stuffy or runny nose
- swollen joints
- tiredness
- trouble concentrating
- trouble with sleeping
- vision blurred
- visual depth perception altered
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
Ambien is used for short-term treatment of insomnia (difficulty falling asleep or staying asleep, or early awakening). A relatively new drug, it is chemically different from other common sleep medications such as Halcion and Dalmane
Rx Only
This Medication Guide has been approved by the U.S. Food and Drug Administration.
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
May 2008
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