Ambien Cr Oral Tablet, Biphasic Release 12.5Mg Drug Medication Dosage Information
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Ambien CR: Oral tablet, biphasic release (12.5mg)

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Most Commonly Used
Drug Image file DrugItem_8841.JPG
Ambien CR 12.5mg Tab
Sanofi-Aventis US LLC
Pill Identification: A~ 

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.

CVS/pharmacy Patient Statistics for Ambien CR: Oral tablet, biphasic release(12.5mg)
Generic vs. Brand Name Usage*
*Brand contains same active ingredient but may not represent FDA-approved generic equivalent
Usage By Strength
In-Depth Information
Select a Medication

Ambien CR 12.5mg Extended-Release Tablet

NDC: 000245521
  • Prescription Required
  • Federally Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Insomnia

Storage Information
Store between 59 to 77 degrees F, limited excursions permitted up to 86 degrees F
Ambien CR 12.5mg Extended-Release Tablet
Drug Image file DrugItem_8841.JPG
Sanofi-Aventis US LLC
Pill Identification: A~ 
Shape: round
Color: blue

Reported Side Effects for Ambien CR 12.5mg Extended-Release Tablet

Intestinal Blockage Incidence:
<0.1%*
Severity: SEVERE
Onset: DELAYED
Impotence (erectile Dysfunction) Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Increased Urination Incidence:
<0.1%*
Severity: MILD
Onset: EARLY
Rapid Heart Rate Incidence:
<0.1%*
Severity: SEVERE
Onset: EARLY
Secretion Of Tears Incidence:
<0.1%*
Severity: MILD
Onset: EARLY
Hives Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Retaining Urine Incidence:
<0.1%*
Severity: MODERATE
Onset: EARLY
Inflamed Vocal Cords Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Decreased Sexual Desire Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Tetany Incidence:
<0.1%*
Severity: MODERATE
Onset: EARLY
Enlarged Lymph Nodes Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Restless Legs Syndrome (RLS) Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Blood Clot In Lung Incidence:
<0.1%*
Severity: SEVERE
Onset: DELAYED
Fluid In Lungs Incidence:
<0.1%*
Severity: SEVERE
Onset: EARLY
Muscle Weakness Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Nighttime Urination Incidence:
<0.1%*
Severity: MILD
Onset: EARLY
Muscle Pain Incidence:
<4.0%*
Severity: MILD
Onset: EARLY
Chills Incidence:
<0.1%*
Severity: MILD
Onset: RAPID
Blistery Rash Incidence:
<0.1%*
Severity: MODERATE
Onset: EARLY
Breathing Difficulties Incidence:
<0.1%*
Severity: SEVERE
Onset: RAPID
Conjunctivitis Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Tooth Cavities Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Low Kidney Function Incidence:
<0.1%*
Severity: SEVERE
Onset: DELAYED
Abnormal Heart Rhythm Incidence:
<0.1%*
Severity: SEVERE
Onset: EARLY
Causing To Be Hungry Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Belching Incidence:
<0.1%*
Severity: MILD
Onset: EARLY
Inceased Urination Incidence:
<0.1%*
Severity: MILD
Onset: EARLY
Heart Attack Incidence:
<0.1%*
Severity: SEVERE
Onset: DELAYED
Flushing Incidence:
<0.1%*
Severity: MILD
Onset: RAPID
Low White Blood Cell Counts Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Hallucinations Incidence:
<7.4%*
Severity: MODERATE
Onset: EARLY
Increased Blood Fats Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Hypoxia Incidence:
<0.1%*
Severity: MODERATE
Onset: EARLY
Nose Bleed Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Kidney Failure Incidence:
<0.1%*
Severity: SEVERE
Onset: DELAYED
Painful Urination Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Drowsiness Incidence:
<8.0%*
Severity: MILD
Onset: EARLY
Tenesmus Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Blood Clot Incidence:
<0.1%*
Severity: SEVERE
Onset: DELAYED
Tolerance Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Visual Impairment Incidence:
<3.0%*
Severity: SEVERE
Onset: EARLY
Weight Loss Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Joint Pain Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Yawning Incidence:
<0.1%*
Severity: MILD
Onset: EARLY
Angioedema Incidence:
<0.1%*
Severity: SEVERE
Onset: RAPID
Chest Pain Incidence:
<0.1%*
Severity: MODERATE
Onset: EARLY
Anemia Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Severe Allergy Incidence:
<0.1%*
Severity: SEVERE
Onset: RAPID
Acne Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Breast Pain Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Low Blood Pressure Incidence:
<0.1%*
Severity: MODERATE
Onset: RAPID
Irritated Blood Vessels Incidence:
<0.1%*
Severity: MODERATE
Onset: RAPID
Extra Saliva Production Incidence:
<0.1%*
Severity: MILD
Onset: EARLY
Photopsia Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
High Cholesterol Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
High Bilirubin Level Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Hot Flashes Incidence:
<0.1%*
Severity: MODERATE
Onset: EARLY
Hemorrhoids Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Photosensitivity Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Bruises Incidence:
<0.1%*
Severity: MILD
Onset: DELAYED
Boils Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Inflamed Stomach Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Gout Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Emotional Lability Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Hypoesthesia Incidence:
0.1-1.0%*
Severity: MILD
Onset: DELAYED
Rhinitis Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Rapid Heart Rate Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: RAPID
Metallic Taste Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Dysarthria Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: DELAYED
Decreased Thinking Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: EARLY
Paresthesias Incidence:
0.1-1.0%*
Severity: MILD
Onset: DELAYED
Nightmares Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Eye Irritation Incidence:
0.1-1.0%*
Severity: MILD
Onset: RAPID
Pale Skin Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Vaginal Infection Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: DELAYED
Uncontrolled Urination Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: EARLY
Shaking Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Ringing In Ears Incidence:
0.1-1.0%*
Severity: MILD
Onset: DELAYED
Itching Incidence:
0.1-1.0%*
Severity: MILD
Onset: RAPID
Sore Throat Incidence:
0.1-1.0%*
Severity: MILD
Onset: DELAYED
Postural Low Blood Pressure Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: DELAYED
Eye Pain Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Migraine Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: EARLY
High Blood Pressure Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: EARLY
Excessive Sweating Incidence:
0.1-1.0%*
Severity: MILD
Onset: DELAYED
Gas Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Swelling Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: DELAYED
Shortness Of Breath Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: EARLY
Bladder Infection Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: DELAYED
Cough Incidence:
0.1-1.0%*
Severity: MILD
Onset: DELAYED
Constipation Incidence:
0.1-2.0%*
Severity: MODERATE
Onset: DELAYED
Nervousness Incidence:
0.1-3.0%*
Severity: MILD
Onset: DELAYED
Decreased Appetite Incidence:
0.1-1.0%*
Severity: MILD
Onset: DELAYED
Distressed Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Difficulty Swallowing Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: DELAYED
Chest Pain Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: EARLY
Increased Blood Sugar Incidence:
0.1-1.0%*
Severity: MODERATE
Onset: DELAYED
Fainting Incidence:
0.1-1.0%*
Severity: MILD
Onset: EARLY
Infection Incidence:
0.1-1.0%*
Severity: MILD
Onset: DELAYED
Tired Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
1.0-2.0%*
Severity: MILD
Onset: EARLY
Weakness Incidence:
>1.0%*
Severity: MILD
Onset: DELAYED
Incoordination Incidence:
>1.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Depression Incidence:
1.0-2.0%*
Severity: MODERATE
Onset: DELAYED
Lightheadedness Incidence:
1.0-23.5%*
Severity: MILD
Onset: EARLY
Double Vision Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Vaginal Irritation Incidence:
1.0%*
Severity: MILD
Onset: EARLY
Confusion Incidence:
>1.0%*
Severity: MODERATE
Onset: EARLY
Upset Stomach Incidence:
1.0-7.0%*
Severity: MILD
Onset: EARLY
Decreased Memory Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Balance Problems Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Heavy Menstrual Period Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Hiccups Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Flu Incidence:
1.0-3.0%*
Severity: MILD
Onset: DELAYED
Heartburn Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Inability To Sleep Incidence:
>1.0%*
Severity: MILD
Onset: EARLY
Elated Mood Incidence:
>1.0%*
Severity: MODERATE
Onset: EARLY
Loss Of Memory Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Rapid Heart Rate Incidence:
2.0%*
Severity: MODERATE
Onset: EARLY
Muscle Cramps Incidence:
2.0%*
Severity: MILD
Onset: DELAYED
Psychomotor Impairment Incidence:
2.0-3.0%*
Severity: MILD
Onset: EARLY
Red Eyes Incidence:
2.0%*
Severity: MODERATE
Onset: EARLY
Blurred Vision Incidence:
2.0%*
Severity: MODERATE
Onset: EARLY
Headache Incidence:
3.0-19.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
3.0-6.0%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
3.0-4.0%*
Severity: MILD
Onset: DELAYED
Tiredness Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Dry Mouth Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Sinus Infection Incidence:
4.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Ambien CR 12.5mg Extended-Release Tablet

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Alcohol and Ambien CR 12.5mg Extended-Release Tablet(Zolpidem Tartrate)
Alcohol and CNS Depressants(Zolpidem Tartrate)
Avoid alcohol-containing drinks while taking this medicine. Using this drug along with alcohol can lead to serious side effects. You may feel drowsy or more tired when taking these drugs together. Do not drive or operate machinery until you know how this drug affects you, and especially if you are drinking alcohol-containing beverages. If you notice slurred speech, confusion, severe weakness, or difficulty breathing, contact your health care provider immediately.
Minor Lifestyle Interaction
Caffeine-containing Foods/Beverages and Ambien CR 12.5mg Extended-Release Tablet(Zolpidem Tartrate)
Caffeine-containing Foods/Beverages and Zolpidem Tartrate(Zolpidem Tartrate)
Caffeine is a stimulant and may keep you awake when taken at night. Avoid Caffeine-containing beverages or products prior to going to bed since Caffeine can decrease the ability of Zolpidem to help you sleep.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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