ZOLPIDEM

Zolpidem Adverse Events Reported to the FDA Over Time

How are Zolpidem adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Zolpidem, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Zolpidem is flagged as the suspect drug causing the adverse event.

Most Common Zolpidem Adverse Events Reported to the FDA

What are the most common Zolpidem adverse events reported to the FDA?

Amnesia	1764 (3.76%)
Completed Suicide	1169 (2.49%)
Somnambulism	1078 (2.3%)
Road Traffic Accident	1055 (2.25%)
Drug Ineffective	903 (1.93%)
Fall	826 (1.76%)
Insomnia	623 (1.33%)
Confusional State	600 (1.28%)
Impaired Driving Ability	589 (1.26%)
Loss Of Consciousness	581 (1.24%)
Somnolence	547 (1.17%)
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Abnormal Behaviour	536 (1.14%)
Hallucination	459 (.98%)
Cardiac Arrest	404 (.86%)
Overdose	399 (.85%)
Depression	368 (.79%)
Respiratory Arrest	363 (.77%)
Anxiety	353 (.75%)
Dizziness	321 (.69%)
Suicide Attempt	318 (.68%)
Intentional Overdose	308 (.66%)
Headache	300 (.64%)
Intentional Drug Misuse	295 (.63%)
Delirium	292 (.62%)
Drug Interaction	285 (.61%)
Suicidal Ideation	282 (.6%)
Nausea	275 (.59%)
Abnormal Sleep-related Event	264 (.56%)
Pain	264 (.56%)
Contusion	257 (.55%)
Vomiting	254 (.54%)
Fatigue	251 (.54%)
Feeling Abnormal	246 (.52%)
Death	245 (.52%)
Disorientation	241 (.51%)
Drug Abuse	241 (.51%)
Drug Dependence	237 (.51%)
Agitation	235 (.5%)
Product Substitution Issue	228 (.49%)
Tremor	225 (.48%)
Memory Impairment	224 (.48%)
Drug Toxicity	216 (.46%)
Coma	207 (.44%)
Aggression	205 (.44%)
Eating Disorder	203 (.43%)
Poisoning	203 (.43%)
Drug Withdrawal Syndrome	202 (.43%)
Convulsion	200 (.43%)
Dyspnoea	199 (.42%)
Sleep Talking	198 (.42%)
Asthenia	197 (.42%)
Multiple Drug Overdose Intentional	195 (.42%)
Weight Increased	190 (.41%)
Cardio-respiratory Arrest	188 (.4%)
Condition Aggravated	183 (.39%)
Sleep-related Eating Disorder	181 (.39%)
Gait Disturbance	180 (.38%)
Depressed Level Of Consciousness	170 (.36%)
Hypotension	170 (.36%)
Incorrect Dose Administered	166 (.35%)
Malaise	159 (.34%)
Hallucination, Visual	158 (.34%)
Dysarthria	148 (.32%)
Diarrhoea	145 (.31%)
Hyperhidrosis	141 (.3%)
Balance Disorder	140 (.3%)
Multiple Drug Overdose	135 (.29%)
Hypertension	133 (.28%)
Nightmare	133 (.28%)
Head Injury	131 (.28%)
Product Quality Issue	131 (.28%)
Drug Exposure During Pregnancy	125 (.27%)
Chest Pain	119 (.25%)
Pyrexia	117 (.25%)
Back Pain	116 (.25%)
Unresponsive To Stimuli	114 (.24%)
Syncope	112 (.24%)
Mental Status Changes	111 (.24%)
Irritability	109 (.23%)
Drug Abuser	105 (.22%)
Pain In Extremity	105 (.22%)
Weight Decreased	104 (.22%)
Skin Laceration	103 (.22%)
Disturbance In Attention	101 (.22%)
Medication Error	100 (.21%)
Restlessness	98 (.21%)
Wrong Technique In Drug Usage Proce...	98 (.21%)
Drug Effect Decreased	97 (.21%)
Middle Insomnia	97 (.21%)
Abnormal Dreams	96 (.2%)
Blood Pressure Increased	94 (.2%)
Psychotic Disorder	93 (.2%)
Sleep Disorder	91 (.19%)
Thinking Abnormal	91 (.19%)
Dehydration	88 (.19%)
Palpitations	88 (.19%)
Heart Rate Increased	87 (.19%)
Delusion	86 (.18%)
Pneumonia Aspiration	86 (.18%)
Therapeutic Response Unexpected Wit...	85 (.18%)
Rib Fracture	83 (.18%)

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This graph shows the top adverse events submitted to the FDA for Zolpidem, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zolpidem is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Zolpidem

What are the most common Zolpidem adverse events reported to the FDA?

Neurological	3411 (7.28%)
Injuries	3281 (7%)
Sleep Disorders	2913 (6.22%)
Mental Impairment	2256 (4.81%)
Suicidal And Self-injurious Behavio...	1889 (4.03%)
Therapeutic And Nontherapeutic Effe...	1836 (3.92%)
Medication Errors	1717 (3.66%)
Respiratory	1209 (2.58%)
Deliria	1134 (2.42%)
Psychiatric	1105 (2.36%)
Cardiac Arrhythmias	1044 (2.23%)
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Anxiety Disorders	969 (2.07%)
Lifestyle Issues	954 (2.04%)
Disturbances In Thinking	933 (1.99%)
Bone And Joint Injuries	862 (1.84%)
Gastrointestinal Signs	798 (1.7%)
Epidermal And Dermal Conditions	642 (1.37%)
Chemical Injury And Poisoning	639 (1.36%)
Psychiatric And Behavioural Symptom...	603 (1.29%)
Movement Disorders	501 (1.07%)
Depressed Mood Disorders	491 (1.05%)
Musculoskeletal And Connective Tiss...	476 (1.02%)
Personality Disorders	420 (.9%)
Hepatic And Hepatobiliary	419 (.89%)
Infections - Pathogen Unspecified	407 (.87%)
Product Quality Issues	407 (.87%)
Cardiac And Vascular Investigations	378 (.81%)
Muscle	372 (.79%)
Physical Examination Topics	350 (.75%)
Headaches	346 (.74%)
Fatal Outcomes	342 (.73%)
Seizures	329 (.7%)
Legal Issues	314 (.67%)
Lower Respiratory Tract Disorders	304 (.65%)
Mood Disorders	287 (.61%)
Hepatobiliary	259 (.55%)
Gastrointestinal Motility And Defec...	252 (.54%)
Urinary Tract Signs	238 (.51%)
Renal Disorders	237 (.51%)
Hematology Investigations	234 (.5%)
Eating Disorders	230 (.49%)
Decreased And Nonspecific Blood Pre...	229 (.49%)
Central Nervous System Vascular	222 (.47%)
Electrolyte And Fluid Balance Condi...	222 (.47%)
Metabolic, Nutritional And Blood Ga...	221 (.47%)
Changes In Physical Activity	205 (.44%)
Skin Appendage Conditions	204 (.44%)
Joint	203 (.43%)
Vision	191 (.41%)
Body Temperature Conditions	181 (.39%)
Ocular Neuromuscular	177 (.38%)
Appetite And General Nutritional	167 (.36%)
Toxicology And Therapeutic Drug Mon...	167 (.36%)
Cardiac Disorder Signs	160 (.34%)
White Blood Cell	147 (.31%)
Vascular Hemorrhagic	141 (.3%)
Vascular Hypertensive	141 (.3%)
Enzyme	130 (.28%)
Encephalopathies	128 (.27%)
Schizophrenia And Other Psychotic	123 (.26%)
Bacterial Infectious	121 (.26%)
Therapeutic Procedures And Supporti...	121 (.26%)
Allergic Conditions	115 (.25%)
Water, Electrolyte And Mineral	115 (.25%)
Anemias Nonhemolytic And Marrow Dep...	113 (.24%)
Musculoskeletal And Connective Tiss...	112 (.24%)
Renal And Urinary Tract Investigati...	111 (.24%)
Sleep Disturbances	109 (.23%)
Acid-base	108 (.23%)
Peripheral Neuropathies	97 (.21%)
Inner Ear And Viiith Cranial Nerve	89 (.19%)
Neuromuscular	83 (.18%)
Pleural	81 (.17%)
Skin Vascular Abnormalities	81 (.17%)
Glucose Metabolism Disorders	78 (.17%)
Gastrointestinal Conditions	73 (.16%)
Oral Soft Tissue Conditions	70 (.15%)
Communication Disorders	69 (.15%)
Bone Disorders	68 (.15%)
Abortions And Stillbirth	67 (.14%)
Upper Respiratory Tract Disorders	65 (.14%)
Manic And Bipolar Mood Disorders	64 (.14%)
Salivary Gland Conditions	64 (.14%)
Eye	61 (.13%)
Vascular	60 (.13%)
Bronchial Disorders	58 (.12%)
Musculoskeletal And Connective Tiss...	57 (.12%)
Viral Infectious	57 (.12%)
Coronary Artery	56 (.12%)
Heart Failures	56 (.12%)
Platelet	54 (.12%)
Bladder And Bladder Neck Disorders	53 (.11%)
Gastrointestinal Hemorrhages	53 (.11%)
Arteriosclerosis, Stenosis, Vascula...	49 (.1%)
Dissociative	49 (.1%)
Fungal Infectious	48 (.1%)
Coagulopathies And Bleeding Diathes...	47 (.1%)
Myocardial	47 (.1%)
Neurological, Special Senses And Ps...	47 (.1%)
Gastrointestinal Inflammatory Condi...	46 (.1%)
Neonatal And Perinatal Conditions	46 (.1%)

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This graph shows the top categories of adverse events submitted to the FDA for Zolpidem, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zolpidem is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.