78/100 · Elevated
Manufactured by Aurobindo Pharma Limited
ZALEPLON Adverse Events: High Seriousness and Diverse Reactions
3,045 FDA adverse event reports analyzed
Last updated: 2026-05-12
ZALEPLON is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 3,045 FDA adverse event reports, ZALEPLON has a safety score of 78 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 ZALEPLON include DRUG INEFFECTIVE, NAUSEA, COMPLETED SUICIDE, INSOMNIA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ZALEPLON.
Zaleplon has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 3,045 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Drug Ineffective, Nausea, Completed Suicide. Of classified reports, 57.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. ZALEPLON reports include a high percentage of serious adverse events, particularly related to suicide and falls.
The most common reactions are nausea, insomnia, and headache, indicating potential side effects in users. The drug has been associated with a variety of reactions, including kidney issues and respiratory problems, suggesting a broad safety profile.
Patients taking Zaleplon should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. ZALEPLON is contraindicated in patients with a history of drug abuse or dependence. It should be used with caution in patients with pre-existing kidney conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Zaleplon received a safety concern score of 78/100 (high concern). This is based on a 57.2% serious event ratio across 1,538 classified reports. The score accounts for 3,045 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: 980, Male: 462, Unknown: 8. The most frequently reported age groups are age 67 (40 reports), age 59 (39 reports), age 57 (37 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 1,538 classified reports for ZALEPLON:
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.
ZALEPLON is contraindicated in patients with a history of drug abuse or dependence. It should be used with caution in patients with pre-existing kidney conditions.
If you are taking Zaleplon, here are important things to know. The most commonly reported side effects include drug ineffective, nausea, completed suicide, insomnia, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of suicidal ideation or behavior, especially during the first few weeks of treatment. Avoid driving or operating heavy machinery until the effects of the drug are known, as it may cause dizziness or drowsiness. 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 continues to monitor ZALEPLON for safety and has not issued any new warnings or restrictions based on the current data.
The FDA has received approximately 3,045 adverse event reports associated with Zaleplon. 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 Zaleplon include Drug Ineffective, Nausea, Completed Suicide, Insomnia, Headache. By volume, the top reported reactions are: Drug Ineffective (140 reports), Nausea (111 reports), Completed Suicide (88 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Zaleplon.
Out of 1,538 classified reports, 879 (57.2%) were classified as serious and 659 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 Zaleplon break down by patient sex as follows: Female: 980, Male: 462, Unknown: 8. 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 Zaleplon adverse events are: age 67: 40 reports, age 59: 39 reports, age 57: 37 reports, age 64: 37 reports, age 55: 29 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 Zaleplon 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 Zaleplon include: Fall, Anxiety, Pain, Fatigue, 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 Zaleplon 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.
Zaleplon has a safety concern score of 78 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. ZALEPLON reports include a high percentage of serious adverse events, particularly related to suicide and falls.
Key safety signals identified in Zaleplon's adverse event data include: Suicide and completed suicide are among the most serious adverse events reported.. Falls are a common reaction, indicating potential risk of injury.. Chronic kidney disease and acute kidney injury are noted, highlighting potential renal risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
ZALEPLON is contraindicated in patients with a history of drug abuse or dependence. It should be used with caution in patients with pre-existing kidney conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Zaleplon.
Patients should be closely monitored for signs of suicidal ideation or behavior, especially during the first few weeks of treatment. Avoid driving or operating heavy machinery until the effects of the drug are known, as it may cause dizziness or drowsiness.
Zaleplon has 3,045 adverse event reports on file with the FDA. The most common reactions are nausea, insomnia, and headache, indicating potential side effects in users. The volume of reports for Zaleplon reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor ZALEPLON for safety and has not issued any new warnings or restrictions based on the current data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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