Ambien

DRUG DESCRIPTION

Ambien (zolpidem tartrate) is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.

Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:

Ambien® (zolpidem tartrate) Structural Formula Illustration

Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.

Each Ambien (zolpidem tartrate) tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.

What are the possible side effects of zolpidem (Ambien, Ambien CR, Edluar)?

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...

Read All Potential Side Effects and See Pictures of Ambien »

What are the precautions when taking zolpidem tartrate (Ambien)?

Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, mental/mood problems (such as depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol/other substances, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis).

Since this drug makes you drowsy, do not drive, use machinery, or do any activity that requires alertness...

Read All Potential Precautions of Ambien »


Ambien Consumer (continued)

SIDE EFFECTS: Dizziness may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking zolpidem, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, mental/mood problems (such as depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol/other substances, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea), a certain muscle disease (myasthenia gravis).

Since this drug makes you drowsy, do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Older adults may be more sensitive to the effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who have taken sedative-hypnotics near the time of delivery may have undesirable effects such as breathing problems or withdrawal symptoms. Discuss the risks and benefits with your doctor.

A small amount of this medication passes into breast milk. Consult your doctor before breast-feeding.


Ambien Patient Information Including Side Effects

Brand Names: Ambien, Ambien CR, Edluar

Generic Name: zolpidem (Pronunciation: zole PI dem)

  • What is zolpidem (Ambien)?
  • What are the possible side effects of zolpidem (Ambien)?
  • What is the most important information I should know about zolpidem (Ambien)?
  • What should I discuss with my healthcare provider before taking zolpidem (Ambien)?
  • How should I take zolpidem (Ambien)?
  • What happens if I miss a dose (Ambien)?
  • What happens if I overdose (Ambien)?
  • What should I avoid while taking zolpidem (Ambien)?
  • What other drugs will affect zolpidem (Ambien)?
  • Where can I get more information?

What is zolpidem (Ambien)?

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 are the possible side effects of zolpidem (Ambien)?

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about zolpidem (Ambien)?

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.

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