Drug Safety Information for ZOLPIDEM TARTRATE (Zolpidem tartrate)

Safety-related Labeling Changes for AMBIEN (ZOLPIDEM TARTRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for AMBIEN CR (ZOLPIDEM TARTRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for EDLUAR (ZOLPIDEM TARTRATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ZOLPIMIST (ZOLPIDEM TARTRATE) Rx Drug: FDA Link

Adverse Drug Reactions for ZOLPIDEM TARTRATE* (Zolpidem tartrate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with ZOLPIDEM TARTRATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea4348
2Drug ineffective4282
3Fatigue3559
4Insomnia3421
5Pain3256
6Dyspnoea3054
7Headache3012
8Anxiety*2839
9Fall2821
10Diarrhoea2770
11Dizziness*2750
12Vomiting2679
13Depression2675
14Asthenia2456
15Completed suicide2321
16Amnesia*2134
17Pyrexia1929
18Confusional state1921
19Arthralgia1775
20Malaise1747

* This side effect also appears in "Top 10 Side Effects of ZOLPIDEM TARTRATE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking ZOLPIDEM TARTRATE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Insomnia*49175
2Product used for unknown indication37594
3Sleep disorder*21395
4Sleep disorder therapy2338
5Depression1574
6Anxiety*518
7Pain507
8Somnolence479
9Suicide attempt410
10Ill-defined disorder394

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for ZOLPIDEM TARTRATE

Total Reports Filed with FDA: 348741


Number of FDA Adverse Event Reports by Patient Age for ZOLPIDEM TARTRATE

Total Reports Filed with FDA: 348741*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Zolpidem tartrate (Tovalt odt, Zolpidem, Zolpimist, Zoldem, Dalparan, Bikalm, Stilnoct, Zolpidem tatrate, Stilnox, Intermezzo, Zolpidem tartrate, Ambien, Edluar, Ambien cr)

Charts are based on 348741 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

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Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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