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Sonata Adverse Events Reported to the FDA Over Time

How are Sonata adverse event reports trending over time?

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

Most Common Sonata Adverse Events Reported to the FDA

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

Drug Ineffective
134 (14.6%)
Middle Insomnia
41 (4.47%)
Somnolence
26 (2.83%)
Drug Effect Decreased
25 (2.72%)
Suicide Attempt
25 (2.72%)
Intentional Overdose
23 (2.51%)
Overdose
20 (2.18%)
Headache
15 (1.63%)
Fatigue
13 (1.42%)
Feeling Abnormal
13 (1.42%)
Hallucination
13 (1.42%)
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Insomnia
13 (1.42%)
Amnesia
12 (1.31%)
Tachycardia
12 (1.31%)
Anxiety
11 (1.2%)
Dizziness
11 (1.2%)
Confusional State
10 (1.09%)
Somnambulism
9 (.98%)
Agitation
8 (.87%)
Multiple Drug Overdose Intentional
8 (.87%)
Poor Quality Sleep
8 (.87%)
Road Traffic Accident
8 (.87%)
Completed Suicide
7 (.76%)
Death
7 (.76%)
Euphoric Mood
7 (.76%)
Hallucination, Visual
7 (.76%)
Hypotension
7 (.76%)
Impaired Driving Ability
7 (.76%)
Multiple Drug Overdose
7 (.76%)
Nightmare
7 (.76%)
Aggression
6 (.65%)
Drug Interaction
6 (.65%)
Intentional Drug Misuse
6 (.65%)
Ocular Hyperaemia
6 (.65%)
Delusion
5 (.54%)
Drug Abuser
5 (.54%)
Drug Dependence
5 (.54%)
Dysarthria
5 (.54%)
Dysgeusia
5 (.54%)
Heart Rate Increased
5 (.54%)
Mental Status Changes
5 (.54%)
Nausea
5 (.54%)
Pallor
5 (.54%)
Paranoia
5 (.54%)
Pruritus
5 (.54%)
Sedation
5 (.54%)
Urticaria
5 (.54%)
Coma
4 (.44%)
Coordination Abnormal
4 (.44%)
Drug Withdrawal Syndrome
4 (.44%)
Erythema
4 (.44%)
Hypersomnia
4 (.44%)
Incorrect Dose Administered
4 (.44%)
Initial Insomnia
4 (.44%)
Medication Error
4 (.44%)
Vomiting
4 (.44%)
Abnormal Sleep-related Event
3 (.33%)
Anger
3 (.33%)
Balance Disorder
3 (.33%)
Chromaturia
3 (.33%)
Convulsion
3 (.33%)
Depressed Mood
3 (.33%)
Depression
3 (.33%)
Drug Abuse
3 (.33%)
Drug Tolerance
3 (.33%)
Dyspnoea
3 (.33%)
Hypotonia
3 (.33%)
Malaise
3 (.33%)
Medical Observation Abnormal
3 (.33%)
Mydriasis
3 (.33%)
Nervousness
3 (.33%)
Palpitations
3 (.33%)
Parasomnia
3 (.33%)
Psychomotor Hyperactivity
3 (.33%)
Restless Legs Syndrome
3 (.33%)
Suicidal Ideation
3 (.33%)
Tremor
3 (.33%)
Abnormal Behaviour
2 (.22%)
Accidental Death
2 (.22%)
Adverse Reaction
2 (.22%)
Alcohol Use
2 (.22%)
Anoxic Encephalopathy
2 (.22%)
Arthralgia
2 (.22%)
Asthenia
2 (.22%)
Azotaemia
2 (.22%)
Blood Creatine Phosphokinase Increa...
2 (.22%)
Blood Pressure Increased
2 (.22%)
Cardiac Arrest
2 (.22%)
Circulatory Collapse
2 (.22%)
Condition Aggravated
2 (.22%)
Cyanosis
2 (.22%)
Depressed Level Of Consciousness
2 (.22%)
Disorientation
2 (.22%)
Drug Screen False Positive
2 (.22%)
Dry Mouth
2 (.22%)
Dysphagia
2 (.22%)
Elevated Mood
2 (.22%)
Encephalopathy
2 (.22%)
Faecal Incontinence
2 (.22%)
Feeling Drunk
2 (.22%)
Feeling Jittery
2 (.22%)

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This graph shows the top adverse events submitted to the FDA for Sonata, 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 Sonata 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 Sonata

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

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This graph shows the top categories of adverse events submitted to the FDA for Sonata, 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 Sonata 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 Sonata According to Those Reporting Adverse Events

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

Insomnia
187
Sleep Disorder
86
Drug Use For Unknown Indication
20
Product Used For Unknown Indication
19
Sleep Disorder Therapy
9
Middle Insomnia
6
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Initial Insomnia
4
Restless Legs Syndrome
4
Bipolar I Disorder
2
Circadian Rhythm Sleep Disorder
1
Suicide Attempt
1
Depression
1
Pain
1
Ill-defined Disorder
1
Completed Suicide
1
Intentional Overdose
1
Poor Quality Sleep
1
Fibromyalgia
1
Mania
1
Delayed Sleep Phase
1
Muscle Spasms
1
Somnolence
1
Anxiety
1
Overdose
1

Drug Labels

LabelLabelerEffective
SonataPhysicians Total Care, Inc.27-MAY-10
SonataKing Pharmaceuticals, Inc.26-APR-12

Sonata Case Reports

What Sonata 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 Sonata. 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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