85/100 · Critical
Manufactured by Aurobindo Pharma Limited
Zolpidem Tartrate Adverse Events: High Seriousness and Diverse Reactions
262,151 FDA adverse event reports analyzed
Last updated: 2026-05-12
ZOLPIDEM TARTRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 262,151 FDA adverse event reports, ZOLPIDEM TARTRATE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for ZOLPIDEM TARTRATE include DRUG INEFFECTIVE, NAUSEA, FATIGUE, PAIN, INSOMNIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ZOLPIDEM TARTRATE.
Zolpidem Tartrate has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 262,151 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Drug Ineffective, Nausea, Fatigue. Of classified reports, 69.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (69.2%) among total reports.
Diverse range of reactions including neurological, gastrointestinal, and cardiovascular issues. Significant number of reports involving falls, confusion, and suicidal ideation.
Patients taking Zolpidem Tartrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Zolpidem Tartrate can cause drowsiness and impaired coordination, which may lead to falls and other accidents. Patients should avoid driving or operating machinery after taking the drug. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Zolpidem Tartrate received a safety concern score of 85/100 (high concern). This is based on a 69.2% serious event ratio across 131,631 classified reports. The score accounts for 262,151 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 79,110, Male: 44,664, Unknown: 302. The most frequently reported age groups are age 65 (2,263 reports), age 61 (2,206 reports), age 62 (2,184 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 131,631 classified reports for ZOLPIDEM TARTRATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Zolpidem Tartrate can cause drowsiness and impaired coordination, which may lead to falls and other accidents. Patients should avoid driving or operating machinery after taking the drug.
If you are taking Zolpidem Tartrate, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, fatigue, pain, insomnia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Do not drive or operate machinery after taking Zolpidem Tartrate as it can cause drowsiness and impaired coordination. Follow the prescribed dosage and do not exceed the recommended dose. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA has issued warnings about the risks associated with Zolpidem Tartrate, particularly for patients over 65 years old. Regular monitoring and dose adjustments are recommended.
The FDA has received approximately 262,151 adverse event reports associated with Zolpidem Tartrate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Zolpidem Tartrate include Drug Ineffective, Nausea, Fatigue, Pain, Insomnia. By volume, the top reported reactions are: Drug Ineffective (8,549 reports), Nausea (8,385 reports), Fatigue (8,148 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Zolpidem Tartrate.
Out of 131,631 classified reports, 91,144 (69.2%) were classified as serious and 40,487 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Zolpidem Tartrate break down by patient sex as follows: Female: 79,110, Male: 44,664, Unknown: 302. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Zolpidem Tartrate adverse events are: age 65: 2,263 reports, age 61: 2,206 reports, age 62: 2,184 reports, age 60: 2,156 reports, age 64: 2,089 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Zolpidem Tartrate adverse event reports is Aurobindo Pharma Limited. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Zolpidem Tartrate include: Headache, Diarrhoea, Fall, Anxiety, Dizziness. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Zolpidem Tartrate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Zolpidem Tartrate has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High percentage of serious adverse events (69.2%) among total reports.
Key safety signals identified in Zolpidem Tartrate's adverse event data include: High number of serious adverse events (91,144) out of total reports (131,631).. Multiple neurological reactions such as falls, confusion, and dizziness.. Reports of suicidal ideation and completed suicides.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Zolpidem Tartrate can cause drowsiness and impaired coordination, which may lead to falls and other accidents. Patients should avoid driving or operating machinery after taking the drug. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Zolpidem Tartrate.
Do not drive or operate machinery after taking Zolpidem Tartrate as it can cause drowsiness and impaired coordination. Follow the prescribed dosage and do not exceed the recommended dose.
Zolpidem Tartrate has 262,151 adverse event reports on file with the FDA. Diverse range of reactions including neurological, gastrointestinal, and cardiovascular issues. The volume of reports for Zolpidem Tartrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings about the risks associated with Zolpidem Tartrate, particularly for patients over 65 years old. Regular monitoring and dose adjustments are recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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