Dosage and Administration ( |
2/2022 |
Warnings and Precautions ( |
2/2022 |
Warnings and Precautions ( |
2/2022 |
Body System Adverse Reaction |
Zolpidem (≤10 mg) (N=685) |
Placebo (N=473) |
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Headache | 7 | 6 |
Drowsiness | 2 | - |
Dizziness | 1 | - |
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Diarrhea | 1 | - |
Body System Adverse Event |
Zolpidem (≤10 mg) (N=152) |
Placebo (N=161) |
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Dry mouth | 3 | 1 |
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Allergy | 4 | 1 |
Back Pain | 3 | 2 |
Influenza-like symptoms | 2 | - |
Chest pain | 1 | - |
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Palpitation | 2 | - |
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Drowsiness | 8 | 5 |
Dizziness | 5 | 1 |
Lethargy | 3 | 1 |
Drugged feeling | 3 | - |
Lightheadedness | 2 | 1 |
Depression | 2 | 1 |
Abnormal dreams | 1 | - |
Amnesia | 1 | - |
Sleep disorder | 1 | - |
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Diarrhea | 3 | 2 |
Abdominal pain | 2 | 2 |
Constipation | 2 | 1 |
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Sinusitis | 4 | 2 |
Pharyngitis | 3 | 1 |
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Rash | 2 | 1 |
Adverse Event | Zolpidem | Placebo |
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Dizziness | 3% | 0% |
Drowsiness | 5% | 2% |
Diarrhea | 3% | 1% |
NDC Number | Size |
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0024-5401-31 | bottle of 100 |
NDC Number | Size |
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0024-5421-31 | bottle of 100 |
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: 2/2022 |
AMBIEN (zolpidem tartrate) tablets, for oral use, C-IV |
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AMBIEN is a prescription sleep medicine used for the short-term treatment of adults who have trouble falling asleep (insomnia).
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Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. |
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AMBIEN may cause serious side effects, including:
These are not all the side effects of AMBIEN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMBIEN for a condition for which it was not prescribed. Do not give AMBIEN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about AMBIEN that is written for healthcare professionals. |
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Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A SANOFI COMPANY © 2022 sanofi-aventis U.S. LLC For more information, go to WWW.AMBIEN.com or call 1-800-633-1610. |