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Zopiclone Side Effects

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Common Zopiclone Side Effects


The most commonly reported Zopiclone side effects (click to view or check a box to report):

Overdose (12)
Malaise (9)
Suicidal Ideation (9)
Loss Of Consciousness (9)
Anxiety (9)
Depression (8)
Aggression (8)
Dizziness (8)
Hypotension (8)
Insomnia (7)
Fall (7)
Completed Suicide (6)
Cardiac Arrest (6)
Arthralgia (6)
Toxicity To Various Agents (6)
Depressed Mood (6)
Nausea (6)
Electrocardiogram Qt Prolonged (6)
Diarrhoea (6)
Memory Impairment (5)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Zopiclone Side Effects Reported to FDA



Zopiclone Side Effect Report#9994820
Arrhythmia
This is a report of a 74-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Zopiclone Sandoz (dosage: 1 Df, Qd, start time:
Jan 12, 2008), combined with:
  • Clozapine (25 Mg, Bid)
  • Glucophage (2 Df, Bid)
  • Amarel (1 Df, Qd)
  • Modopar (1 Df, Tid)
  • Modopar (1 Df, Qd)
  • Augmentin (1 G, Tid)
and developed a serious reaction and side effect(s): Arrhythmia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zopiclone Sandoz treatment in female patients, resulting in Arrhythmia side effect.
Zopiclone Side Effect Report#9805465
Hypotension, Dizziness, Orthostatic Hypotension, Fall
This report suggests a potential Zopiclone Hypotension side effect(s) that can have serious consequences. A 83-year-old female patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: insomnia,hypertension,coronary artery disease,coronary artery bypass and used Zopiclone (dosage: NA) starting NS. After starting Zopiclone the patient began experiencing various side effects, including: Hypotension, Dizziness, Orthostatic Hypotension, FallAdditional drugs used concurrently:
  • Amlodipine (salt Not Specified) (- Took Half A 5 Mg Tablet (2.5 Mg) Twice Daily)
  • Metoprolol Salt Not Specified (- Took Half A 50 Mg Tablet (25 Mg) Twice Daily)
  • Metoprolol Salt Not Specified (- Took Half A 50 Mg Tablet (25 Mg) Twice Daily)
  • Ramipril (Every Morning)
  • Furosemide (Every Morning)
  • Oxazepam (2, 10 Mg Tablets)
  • Nitroglycerine (Patch)
  • Clopidogrel (Every Morning)
The patient was hospitalized. Although Zopiclone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypotension, may still occur.
Zopiclone Side Effect Report#9794673
Hypertriglyceridaemia
This Hypertriglyceridaemia problem was reported by a consumer or non-health professional from FR. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 26, 2013 this consumer started treatment with Zopiclone (dosage: 0.5 Df, Daily). The following drugs were being taken at the same time:
  • Valacyclovir (500 Mg, Daily)
  • Venlafaxine (37.5 Mg, Daily)
  • Kidrolase (10600 Iu, 1 In 1 Cycle)
  • Methylprednisolone (30 Mg, Bid)
  • Uromitexan (400 Mg, 1 In 1 Cycle)
  • Vincristin Teva (2 Mg, 1 In 1 Cycle)
  • Endoxan /00021101/ (1300 Mg, 1 In 1 Cycle)
  • Aclotine (3000 Iu, 1 In 1 Cycle)
When using Zopiclone, the patient experienced the following unwanted symptoms/side effects: HypertriglyceridaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypertriglyceridaemia, may become evident only after a product is in use by the general population.
Zopiclone Side Effect Report#9694805
Unresponsive To Stimuli
This Unresponsive To Stimuli side effect was reported by a consumer or non-health professional from CA. A 30-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Zopiclone (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Lorazepam (Unk)
  • Clonazepam (Unk)
  • Oxycodone (Unk)
  • Citalopram
  • Cyclobenzaprine
.After starting to take Zopiclone the consumer reported adverse symptoms, such as: Unresponsive To StimuliThese side effects may potentially be related to Zopiclone.
Zopiclone Side Effect Report#9426944
Exposure During Pregnancy
This is a report of a 36-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Zopiclone (dosage: NA, start time: NS), combined with:
  • Omeprazole
  • Diazepam
  • Diazepam
  • Subutex
  • Olanzapine
  • Pregabalin
and developed a serious reaction and side effect(s): Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zopiclone treatment in female patients, resulting in Exposure During Pregnancy side effect.
Zopiclone Side Effect Report#9294215
Delusion, Major Depression, Agranulocytosis, Cerebral Ventricle Dilatation, Neuroleptic Malignant Syndrome
This report suggests a potential Zopiclone Delusion side effect(s) that can have serious consequences. A 44-year-old female patient (weight: NA) from NO was diagnosed with the following symptoms/conditions: NA and used Zopiclone (dosage: Unk) starting NS. After starting Zopiclone the patient began experiencing various side effects, including: Delusion, Major Depression, Agranulocytosis, Cerebral Ventricle Dilatation, Neuroleptic Malignant SyndromeAdditional drugs used concurrently:
  • Quetiapine Fumarate (1800 Mg, A Day)
  • Clozapine (Unk)
  • Alimemazine (Unk)
  • Ziprasidone Hydrochloride (Unk)
  • Lithium
  • Lorazepam (Unk)
  • Chlorprothixene (Unk)
Although Zopiclone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Delusion, may still occur.
Zopiclone Side Effect Report#9025257
Memory Impairment
This Memory Impairment problem was reported by a health professional from GB. A 34-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: insomnia related to another mental condition,bipolar disorder. On
Nov 10, 2010 this consumer started treatment with Zopiclone (dosage: 15 Mg At Qpm). The following drugs were being taken at the same time:
  • Lithium Carbonate (900 Mg Qpm)
When using Zopiclone, the patient experienced the following unwanted symptoms/side effects: Memory ImpairmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Memory Impairment, may become evident only after a product is in use by the general population.
Zopiclone Side Effect Report#9011066
Memory Impairment
This Memory Impairment side effect was reported by a consumer or non-health professional from GB. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: insomnia related to another mental condition,bipolar disorder.The patient was prescribed Zopiclone (drug dosage: NA), which was initiated on
Nov 10, 2010. Concurrently used drugs:
  • Lithium Carbonate
  • Lamotrigine
  • Seretide
  • Ciprofloxacin
.After starting to take Zopiclone the consumer reported adverse symptoms, such as: Memory ImpairmentThese side effects may potentially be related to Zopiclone.
Zopiclone Side Effect Report#8948132
Mania, Unevaluable Event
This is a report of a 46-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Zopiclone (dosage: NA, start time: 201210), combined with:
  • Citalopram (citalopram)
  • Citalopram (citalopram)
and developed a serious reaction and side effect(s): Mania, Unevaluable Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zopiclone treatment in male patients, resulting in Mania side effect.
Zopiclone Side Effect Report#8935243
Pulmonary Embolism, Respiratory Arrest, Hyperventilation, Hypotension, Tachycardia, Aggression, Agitation, Cold Sweat
This report suggests a potential Zopiclone Pulmonary Embolism side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: NA and used Zopiclone (dosage: NA) starting
Jun 20, 2012. After starting Zopiclone the patient began experiencing various side effects, including: Pulmonary Embolism, Respiratory Arrest, Hyperventilation, Hypotension, Tachycardia, Aggression, Agitation, Cold SweatAdditional drugs used concurrently:
  • Alprazolam (5 Mg, Unk)
  • Tavor (lorazepam) (1 Mg, Unk)
  • Tavor (lorazepam) (1 Mg, Unk)
  • Alcohol
Although Zopiclone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Embolism, may still occur.
Zopiclone Side Effect Report#8851241
Coma, Aggression, Disorientation, Delusion
This Coma problem was reported by a health professional from DE. A 21-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Zopiclone (dosage: NA). The following drugs were being taken at the same time:
  • Quetiapine
  • Oxazepam (10mg)
When using Zopiclone, the patient experienced the following unwanted symptoms/side effects: Coma, Aggression, Disorientation, DelusionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Coma, may become evident only after a product is in use by the general population.
Zopiclone Side Effect Report#8851241
Coma, Aggression, Disorientation, Delusion
This Coma side effect was reported by a health professional from DE. A 21-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Zopiclone (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Quetiapine
  • Oxazepam (10mg)
.After starting to take Zopiclone the consumer reported adverse symptoms, such as: Coma, Aggression, Disorientation, DelusionThese side effects may potentially be related to Zopiclone. The patient was hospitalized.
Zopiclone Side Effect Report#8847192
Mouth Ulceration, Skin Exfoliation, Anisocytosis, Off Label Use, Mouth Ulceration
This is a report of a 57-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Zopiclone (dosage: NA, start time: NS), combined with:
  • Lamotrigine
  • Levothyroxine
  • Topiramate
  • Duloxetine
and developed a serious reaction and side effect(s): Mouth Ulceration, Skin Exfoliation, Anisocytosis, Off Label Use, Mouth Ulceration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zopiclone treatment in female patients, resulting in Mouth Ulceration side effect.
Zopiclone Side Effect Report#8764682
Substance-induced Psychotic Disorder, Fear, Depersonalisation, Heart Rate Increased, Hypotension, Paralysis, Derealisation, Hallucination, Tachyphrenia
This report suggests a potential Zopiclone Substance-induced Psychotic Disorder side effect(s) that can have serious consequences. A 45-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: insomnia related to another mental condition,mental disorder and used Zopiclone (dosage: NA) starting
Jun 01, 2012. After starting Zopiclone the patient began experiencing various side effects, including: Substance-induced Psychotic Disorder, Fear, Depersonalisation, Heart Rate Increased, Hypotension, Paralysis, Derealisation, Hallucination, TachyphreniaAdditional drugs used concurrently:
  • Venlafaxine
  • Pregabalin
Although Zopiclone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Substance-induced Psychotic Disorder, may still occur.
Zopiclone Side Effect Report#8740112
Dementia
This Dementia problem was reported by a physician from GB. A 86-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: insomnia. On 2001 this consumer started treatment with Zopiclone (dosage: 3.75 Mg, At Bedtime). The following drugs were being taken at the same time:
  • Bicalutamide
  • Zoladex (Unk)
  • Senna (Dose: 1-2 Nocte)
  • Quetiapine (50 Milligram Daily;)
  • Lansoprazole
  • Furosemide (40 Milligram Daily;)
  • Aspirin
When using Zopiclone, the patient experienced the following unwanted symptoms/side effects: DementiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dementia, may become evident only after a product is in use by the general population.
Zopiclone Side Effect Report#8479738-5
Bowen's Disease, Squamous Cell Carcinoma Of Skin
This Bowen's Disease side effect was reported by a physician from Canada. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Zopiclone (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Vemurafenib And Vemurafenib (Last Dose Prior To Sae: 05 Jan 2011)
  • Vemurafenib And Vemurafenib
  • Entrophen
  • Slow-k
  • Norvasc
.After starting to take Zopiclone the consumer reported adverse symptoms, such as: Bowen's Disease, Squamous Cell Carcinoma Of SkinThese side effects may potentially be related to Zopiclone.
Zopiclone Side Effect Report#8478605-0
Loss Of Consciousness, Cardiac Arrest, Toxicity To Various Agents, Pulmonary Congestion
This is a report of a 25-year-old female patient (weight: NA) from Sweden, suffering from the following health symptoms/conditions: NA, who was treated with Zopiclone (dosage: NA, start time: NS), combined with:
  • Venlafaxine
  • Herbal Blend Krypton
and developed a serious reaction and side effect(s): Loss Of Consciousness, Cardiac Arrest, Toxicity To Various Agents, Pulmonary Congestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zopiclone treatment in female patients, resulting in Loss Of Consciousness side effect. The patient was hospitalized.
Zopiclone Side Effect Report#8471325-8
Torsade De Pointes, Ventricular Tachycardia, Diarrhoea, Vomiting, Convulsion, Pain, Cardiac Arrest
This report suggests a potential Zopiclone Torsade De Pointes side effect(s) that can have serious consequences. A 47-year-old male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: insomnia and used Zopiclone (dosage: Unk) starting
Jan 01, 2005. After starting Zopiclone the patient began experiencing various side effects, including: Torsade De Pointes, Ventricular Tachycardia, Diarrhoea, Vomiting, Convulsion, Pain, Cardiac ArrestAdditional drugs used concurrently:
  • Propranolol Hcl (10 Mg, 2x/day)
  • Gabapentin
  • Oramorph Sr
  • Sunitinib Malate (50 Mg, 1x/day)
  • Morphine
  • Prozac
The patient was hospitalized. Although Zopiclone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Torsade De Pointes, may still occur.
Zopiclone Side Effect Report#8470941-7
Memory Impairment
This Memory Impairment problem was reported by a physician from Denmark. A 26-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Zopiclone (zopiclone) (dosage: NA). The following drugs were being taken at the same time:
  • Diazepam (5 Mg;tid)
  • Kadian
When using Zopiclone (zopiclone), the patient experienced the following unwanted symptoms/side effects: Memory ImpairmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Memory Impairment, may become evident only after a product is in use by the general population.
Zopiclone Side Effect Report#8469553-0
Folliculitis, Hypertrichosis, Application Site Reaction, Application Site Ulcer, Eczema, Lethargy, Urine Analysis Abnormal, Pollakiuria, Neurodermatitis
This Folliculitis side effect was reported by a physician from Canada. A male patient (weight:NA) experienced the following symptoms/conditions: insomnia,alopecia,nervousness.The patient was prescribed Zopiclone (drug dosage: NA), which was initiated on
Jan 25, 2011. Concurrently used drugs:
  • Minoxidil
.After starting to take Zopiclone the consumer reported adverse symptoms, such as: Folliculitis, Hypertrichosis, Application Site Reaction, Application Site Ulcer, Eczema, Lethargy, Urine Analysis Abnormal, Pollakiuria, NeurodermatitisThese side effects may potentially be related to Zopiclone. The patient was hospitalized.
Zopiclone Side Effect Report#8467393-X
Acute Respiratory Failure, Pyrexia, Malaise, Renal Impairment, Cough, Pneumonia, Electrocardiogram Qt Prolonged, Pleural Effusion, Hypokalaemia
This is a report of a 75-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Zopiclone (dosage: 75 Mg, start time:
Aug 14, 2010), combined with:
  • Flivastatin Sodium (50 Mg,)
  • Mucosolvan (2 Mg,)
  • Bup-4 (10 Mg,)
  • Mucosolvan (45 Mg, Daily)
  • Ambroxol Hydrochloride (45 Mg,)
  • Livact (12.45 G,)
  • Tasigna (200 Mg Daily)
  • Astomin (30 Mg,)
and developed a serious reaction and side effect(s): Acute Respiratory Failure, Pyrexia, Malaise, Renal Impairment, Cough, Pneumonia, Electrocardiogram Qt Prolonged, Pleural Effusion, Hypokalaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zopiclone treatment in male patients, resulting in Acute Respiratory Failure side effect. The patient was hospitalized.
Zopiclone Side Effect Report#8462445-2
Hysterectomy, Pelvic Mass, Ovarian Cancer, Salpingo-oophorectomy
This report suggests a potential Zopiclone Hysterectomy side effect(s) that can have serious consequences. A female patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: sleep disorder,hypertension and used Zopiclone (dosage: NA) starting
Jan 01, 2007. After starting Zopiclone the patient began experiencing various side effects, including: Hysterectomy, Pelvic Mass, Ovarian Cancer, Salpingo-oophorectomyAdditional drugs used concurrently:
  • Perindopril Erbumine
  • Hydrochlorothiazide
  • Trazodone Hcl
  • Remicade (37th Infusion)
  • Methotrexate (1 Cc)
  • Desloratadine
  • Solu-cortef
  • Remicade
The patient was hospitalized. Although Zopiclone demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hysterectomy, may still occur.
Zopiclone Side Effect Report#8461863-6
Respiratory Arrest, Pneumonia Aspiration
This Respiratory Arrest problem was reported by a physician from Denmark. A 47-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: insomnia. On
May 01, 2012 this consumer started treatment with Zopiclone (zopiclone) (dosage: 7.5 Mg;qd;po). The following drugs were being taken at the same time:
  • Nitrazepam (Po)
  • Olanzapine
  • Lorazepam (1 Mg;prn;po)
  • Clozaril (Po)
When using Zopiclone (zopiclone), the patient experienced the following unwanted symptoms/side effects: Respiratory Arrest, Pneumonia AspirationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Respiratory Arrest, may become evident only after a product is in use by the general population.
Zopiclone Side Effect Report#8460008-6
Dyskinesia, Syncope, Muscle Rigidity, Convulsion
This Dyskinesia side effect was reported by a health professional from United Kingdom. A 29-year-old male patient (weight:NA) experienced the following symptoms/conditions: insomnia,abdominal pain,psychotic disorder,agitation.The patient was prescribed Zopiclone (drug dosage: 7.5 Mg, Qd), which was initiated on
May 21, 2012. Concurrently used drugs:
  • Acetaminophen (1 G, Qid)
  • Clopixol (100 Mg Daily)
  • Lorazepam (1 Mg, Qid)
  • Tramadol Hcl
  • Olanzapine (5 Mg, Bid)
  • Codeine (60 Mg, Qid)
.After starting to take Zopiclone the consumer reported adverse symptoms, such as: Dyskinesia, Syncope, Muscle Rigidity, ConvulsionThese side effects may potentially be related to Zopiclone.
Zopiclone Side Effect Report#8459655-7
Aortic Aneurysm, Spinal Column Stenosis
This is a report of a female patient (weight: NA) from Canada, suffering from the following health symptoms/conditions: NA, who was treated with Zopiclone (dosage: NA, start time:
Jun 01, 2007), combined with:
  • Magnesium
  • Folic Acid
  • Ascorbic Acid
  • Remicade
  • Methotrexate
and developed a serious reaction and side effect(s): Aortic Aneurysm, Spinal Column Stenosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Zopiclone treatment in female patients, resulting in Aortic Aneurysm side effect. The patient was hospitalized.


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The appearance of Zopiclone on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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What are common Zopiclone Side Effects for Women?

Women Side EffectsReports
Overdose 8
Insomnia 6
Loss Of Consciousness 6
Anxiety 5
Memory Impairment 5
Nausea 5
Arthralgia 4
Blood Creatine Phosphokinase Increased 4
Cardiac Arrest 4
Depression 4

What are common Zopiclone Side Effects for Men?

Men Side EffectsReports
Suicidal Ideation 8
Malaise 7
Aggression 6
Depressed Mood 5
Hypotension 5
Anxiety 4
Completed Suicide 4
Confusional State 4
Death 4
Depression 4

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Why Your Notes are Important

Your notes could be helpful in several ways:

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  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Zopiclone reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Discuss Zopiclone Side Effects

    Did You Have a Zopiclone Side Effect?

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    How Effective is Zopiclone for You?

    Exceeded Expectations
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    Zopiclone Safety Alerts, Active Ingredients, Usage Information

    NDC0054-0290
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary Nameeszopiclone
    Nameeszopiclone
    Dosage FormTABLET
    RouteORAL
    On market since20140415
    LabelerRoxane Laboratories, Inc.
    Active Ingredient(s)ESZOPICLONE
    Strength(s)1
    Unit(s)mg/1
    Pharma Class

    More About Zopiclone

    Side Effects reported to FDA: 198

    Zopiclone safety alerts: 2013 2007

    Reported deaths: 29

    Reported hospitalizations: 60

    Lunesta (eszopiclone)

    Audience: Healthcare professionals, consumers

    [Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers about risks and advise them of potential precautions that can be taken.

    [March 14, 2007 - News Release - FDA]

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