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Ambien Adverse Events Reported to the FDA Over Time

How are Ambien adverse event reports trending over time?

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

Most Common Ambien Adverse Events Reported to the FDA

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

Amnesia
1759 (3.77%)
Completed Suicide
1166 (2.5%)
Somnambulism
1078 (2.31%)
Road Traffic Accident
1051 (2.25%)
Drug Ineffective
900 (1.93%)
Fall
822 (1.76%)
Insomnia
623 (1.34%)
Confusional State
596 (1.28%)
Impaired Driving Ability
588 (1.26%)
Loss Of Consciousness
575 (1.23%)
Somnolence
542 (1.16%)
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Abnormal Behaviour
534 (1.14%)
Hallucination
453 (.97%)
Cardiac Arrest
402 (.86%)
Overdose
399 (.86%)
Depression
367 (.79%)
Respiratory Arrest
363 (.78%)
Anxiety
351 (.75%)
Dizziness
319 (.68%)
Suicide Attempt
317 (.68%)
Intentional Overdose
304 (.65%)
Headache
300 (.64%)
Intentional Drug Misuse
294 (.63%)
Delirium
292 (.63%)
Drug Interaction
282 (.6%)
Suicidal Ideation
282 (.6%)
Nausea
275 (.59%)
Abnormal Sleep-related Event
264 (.57%)
Pain
264 (.57%)
Contusion
257 (.55%)
Vomiting
251 (.54%)
Fatigue
247 (.53%)
Death
243 (.52%)
Feeling Abnormal
243 (.52%)
Disorientation
241 (.52%)
Drug Abuse
240 (.51%)
Drug Dependence
236 (.51%)
Agitation
233 (.5%)
Product Substitution Issue
228 (.49%)
Memory Impairment
224 (.48%)
Tremor
224 (.48%)
Drug Toxicity
216 (.46%)
Coma
207 (.44%)
Aggression
204 (.44%)
Eating Disorder
203 (.44%)
Poisoning
203 (.44%)
Drug Withdrawal Syndrome
202 (.43%)
Convulsion
200 (.43%)
Dyspnoea
199 (.43%)
Sleep Talking
198 (.42%)
Asthenia
195 (.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 (.39%)
Hypotension
170 (.36%)
Depressed Level Of Consciousness
169 (.36%)
Incorrect Dose Administered
163 (.35%)
Malaise
159 (.34%)
Hallucination, Visual
157 (.34%)
Dysarthria
148 (.32%)
Diarrhoea
145 (.31%)
Balance Disorder
139 (.3%)
Hyperhidrosis
139 (.3%)
Hypertension
133 (.29%)
Multiple Drug Overdose
133 (.29%)
Nightmare
131 (.28%)
Product Quality Issue
131 (.28%)
Head Injury
129 (.28%)
Drug Exposure During Pregnancy
121 (.26%)
Chest Pain
119 (.26%)
Pyrexia
117 (.25%)
Back Pain
114 (.24%)
Unresponsive To Stimuli
112 (.24%)
Syncope
111 (.24%)
Mental Status Changes
110 (.24%)
Irritability
109 (.23%)
Pain In Extremity
105 (.23%)
Weight Decreased
104 (.22%)
Skin Laceration
103 (.22%)
Drug Abuser
102 (.22%)
Disturbance In Attention
101 (.22%)
Medication Error
100 (.21%)
Restlessness
98 (.21%)
Drug Effect Decreased
97 (.21%)
Abnormal Dreams
96 (.21%)
Middle Insomnia
96 (.21%)
Wrong Technique In Drug Usage Proce...
95 (.2%)
Blood Pressure Increased
92 (.2%)
Psychotic Disorder
92 (.2%)
Sleep Disorder
91 (.2%)
Thinking Abnormal
91 (.2%)
Dehydration
88 (.19%)
Heart Rate Increased
87 (.19%)
Delusion
86 (.18%)
Palpitations
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 Ambien, 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 Ambien 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 Ambien

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

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This graph shows the top categories of adverse events submitted to the FDA for Ambien, 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 Ambien 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.

Common Uses of Ambien According to Those Reporting Adverse Events

Why are people taking Ambien, according to those reporting adverse events to the FDA?

Insomnia
8795
Sleep Disorder
3229
Drug Use For Unknown Indication
2853
Product Used For Unknown Indication
2106
Sleep Disorder Therapy
392
Depression
214
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Anxiety
142
Somnolence
95
Ill-defined Disorder
92
Suicide Attempt
78
Pain
72
Prophylaxis
60
Initial Insomnia
55
Sleep Apnoea Syndrome
49
Fibromyalgia
35
Bipolar Disorder
35
Restless Legs Syndrome
30
Poor Quality Sleep
29
Stress
28
Middle Insomnia
27
Intentional Overdose
25
Foetal Exposure During Pregnancy
24
Major Depression
21
Agitation
18
Drug Exposure During Pregnancy
18
Drug Abuse
18
Post-traumatic Stress Disorder
17
Overdose
16
Sedation
14
Mental Disorder
14
Schizophrenia
13
Mood Swings
12
Dementia Alzheimers Type
12
Restlessness
12
Unevaluable Event
11
Intentional Drug Misuse
11
Headache
10
Autonomic Nervous System Imbalance
10
Completed Suicide
10
Bipolar I Disorder
9
Circadian Rhythm Sleep Disorder
9
Fatigue
8
Drug Abuser
8
Psychotic Disorder
8
Panic Attack
8
Sedative Therapy
8
Musculoskeletal Pain
7
Generalised Anxiety Disorder
7
Schizoaffective Disorder
7
Metastatic Renal Cell Carcinoma
6
Joint Dislocation
6

Drug Labels

LabelLabelerEffective
Ambien CrBryant Ranch Prepack30-JUN-09
Ambien CrBryant Ranch Prepack30-JUN-09
AmbienRebel Distributors Corp.01-JUL-09
Ambien CrRebel Distributors Corp.01-OCT-09
Ambien CrPD-Rx Pharmaceuticals, Inc.13-OCT-10
Ambien CrLake Erie Medical & Surgical Supply DBA Quality Care Products LLC16-NOV-11
Ambien CrLake Erie Medical & Surgical Supply DBA Quality Care Products LLC13-DEC-11
Ambien CrSTAT Rx USA LLC30-APR-12
Ambiensanofi-aventis U.S. LLC11-MAY-12
Ambien Crsanofi-aventis U.S. LLC11-MAY-12
AmbienLake Erie Medical & Surgical Supply DBA Quality Care Products LLC22-MAY-12
Ambien Cr St Marys Medical Park Pharmacy10-AUG-12
Ambien CrPhysicians Total Care, Inc.04-SEP-12
Ambien STAT Rx USA LLC18-SEP-12
AmbienBryant Ranch Prepack23-OCT-12
Ambiensanofi-aventis U.S. LLC30-APR-13
Ambien Crsanofi-aventis U.S. LLC30-APR-13

Ambien Case Reports

What Ambien safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Ambien. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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