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Zopiclone Side Effects

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.

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.

Zopiclone Side Effects Reported to FDA

The following 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.


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.
Arrhythmia
on Mar 11, 2014 Female from FR , 74 years of age, was treated with Zopiclone Sandoz. Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: arrhythmia. Zopiclone Sandoz dosage: 1 Df, Qd.
Associated medications used:
  • Clozapine (25 Mg, Bid)
  • Glucophage (2 Df, Bid)
  • Amarel (1 Df, Qd)
  • Modopar (1 Df, Tid)
  • Modopar (1 Df, Qd)
  • Augmentin (1 G, Tid)


Hypotension, Dizziness, Orthostatic Hypotension, Fall
Patient was taking Zopiclone. Patient felt the following Zopiclone side effects: hypotension, dizziness, orthostatic hypotension, fall on Jan 09, 2014 from CA Additional patient health information: Female , 83 years of age, was diagnosed with and. Zopiclone dosage: N/A.
Multiple prescriptions taken:
  • 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)
Patient was hospitalized.

Hypertriglyceridaemia
Adverse event was reported on Jan 02, 2014 by a Female taking Zopiclone (Dosage: 0.5 Df, Daily) . Location: FR , 55 years of age, After Zopiclone was administered, patient encountered several Zopiclone side effects: hypertriglyceridaemia.
Multiple concurrent drugs taken:
  • 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)


Unresponsive To Stimuli
on Nov 19, 2013 Male from CA , 30 years of age, weighting 257.9 lb, was treated with Zopiclone. Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: unresponsive to stimuli. Zopiclone dosage: N/A.
Associated medications used:
  • Lorazepam (Unk)
  • Clonazepam (Unk)
  • Oxycodone (Unk)
  • Citalopram
  • Cyclobenzaprine



Exposure During Pregnancy
on Jul 30, 2013 Female from GB , 36 years of age, was treated with Zopiclone. Patient felt the following Zopiclone side effects: exposure during pregnancy. Zopiclone dosage: N/A.
Multiple prescriptions taken:
  • Omeprazole
  • Diazepam
  • Diazepam
  • Subutex
  • Olanzapine
  • Pregabalin


Delusion, Major Depression, Agranulocytosis, Cerebral Ventricle Dilatation, Neuroleptic Malignant Syndrome
Patient was taking Zopiclone. After Zopiclone was administered, patient encountered several Zopiclone side effects: delusion, major depression, agranulocytosis, cerebral ventricle dilatation, neuroleptic malignant syndrome on May 16, 2013 from NO Additional patient health information: Female , 44 years of age, . Zopiclone dosage: Unk.
Multiple concurrent drugs taken:
  • Quetiapine Fumarate (1800 Mg, A Day)
  • Clozapine (Unk)
  • Alimemazine (Unk)
  • Ziprasidone Hydrochloride (Unk)
  • Lithium
  • Lorazepam (Unk)
  • Chlorprothixene (Unk)


Memory Impairment
Adverse event was reported on Jan 22, 2013 by a Female taking Zopiclone (Dosage: 15 Mg At Qpm) was diagnosed with and. Location: GB , 34 years of age, weighting 149.9 lb, Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: memory impairment.
Associated medications used:
  • Lithium Carbonate (900 Mg Qpm)


Memory Impairment
on Jan 09, 2013 Female from GB , 34 years of age, weighting 149.9 lb, was diagnosed with and was treated with Zopiclone. Patient felt the following Zopiclone side effects: memory impairment. Zopiclone dosage: N/A.
Multiple prescriptions taken:
  • Lithium Carbonate
  • Lamotrigine
  • Seretide
  • Ciprofloxacin


Mania, Unevaluable Event
on Nov 26, 2012 Male from GB , 46 years of age, was treated with Zopiclone. After Zopiclone was administered, patient encountered several Zopiclone side effects: mania, unevaluable event. Zopiclone dosage: N/A.
Multiple concurrent drugs taken:
  • Citalopram (citalopram)
  • Citalopram (citalopram)


Pulmonary Embolism, Respiratory Arrest, Hyperventilation, Hypotension, Tachycardia, Aggression, Agitation, Cold Sweat
Patient was taking Zopiclone. Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: pulmonary embolism, respiratory arrest, hyperventilation, hypotension, tachycardia, aggression, agitation, cold sweat on Nov 29, 2012 from DE Additional patient health information: Male , 51 years of age, . Zopiclone dosage: N/A.
Associated medications used:
  • Alprazolam (5 Mg, Unk)
  • Tavor (lorazepam) (1 Mg, Unk)
  • Tavor (lorazepam) (1 Mg, Unk)
  • Alcohol


Coma, Aggression, Disorientation, Delusion
Adverse event was reported on Oct 19, 2012 by a Male taking Zopiclone (Dosage: N/A) . Location: DE , 21 years of age, Patient felt the following Zopiclone side effects: coma, aggression, disorientation, delusion.
Multiple prescriptions taken:
  • Quetiapine
  • Oxazepam (10mg)
Patient was hospitalized.

Coma, Aggression, Disorientation, Delusion
on Jul 25, 2013 Male from DE , 21 years of age, was treated with Zopiclone. After Zopiclone was administered, patient encountered several Zopiclone side effects: coma, aggression, disorientation, delusion. Zopiclone dosage: N/A.
Multiple concurrent drugs taken:
  • Quetiapine
  • Oxazepam (10mg)
Patient was hospitalized.

Mouth Ulceration, Skin Exfoliation, Anisocytosis, Off Label Use
on Oct 18, 2012 Female from GB , 57 years of age, weighting 112.0 lb, was treated with Zopiclone. Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: mouth ulceration, skin exfoliation, anisocytosis, off label use. Zopiclone dosage: N/A.
Associated medications used:
  • Lamotrigine
  • Levothyroxine
  • Topiramate
  • Duloxetine


Substance-induced Psychotic Disorder, Fear, Depersonalisation, Heart Rate Increased, Hypotension, Paralysis, Derealisation, Hallucination, Tachyphrenia
Patient was taking Zopiclone. Patient felt the following Zopiclone side effects: substance-induced psychotic disorder, fear, depersonalisation, heart rate increased, hypotension, paralysis, derealisation, hallucination, tachyphrenia on Dec 18, 2012 from GB Additional patient health information: Male , 45 years of age, weighting 190.0 lb, was diagnosed with and. Zopiclone dosage: N/A.
Multiple prescriptions taken:
  • Venlafaxine
  • Pregabalin


Dementia
Adverse event was reported on Feb 20, 2013 by a Male taking Zopiclone (Dosage: 3.75 Mg, At Bedtime) was diagnosed with and. Location: GB , 86 years of age, weighting 153.9 lb, After Zopiclone was administered, patient encountered several Zopiclone side effects: dementia.
Multiple concurrent drugs taken:
  • Bicalutamide
  • Zoladex (Unk)
  • Senna (Dose: 1-2 Nocte)
  • Quetiapine (50 Milligram Daily;)
  • Lansoprazole
  • Furosemide (40 Milligram Daily;)
  • Aspirin


Bowen's Disease, Squamous Cell Carcinoma Of Skin
on Jun 22, 2012 Male from CANADA , weighting 205.0 lb, was treated with Zopiclone. Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: bowen's disease, squamous cell carcinoma of skin. Zopiclone dosage: N/A.
Associated medications used:
  • Vemurafenib And Vemurafenib (Last Dose Prior To Sae: 05 Jan 2011)
  • Vemurafenib And Vemurafenib
  • Entrophen
  • Slow-k
  • Norvasc


Loss Of Consciousness, Cardiac Arrest, Toxicity To Various Agents, Pulmonary Congestion
on Jun 28, 2012 Female from SWEDEN , 25 years of age, was treated with Zopiclone. Patient felt the following Zopiclone side effects: loss of consciousness, cardiac arrest, toxicity to various agents, pulmonary congestion. Zopiclone dosage: N/A.
Multiple prescriptions taken:
  • Venlafaxine
  • Herbal Blend Krypton
Patient was hospitalized.

Torsade De Pointes, Ventricular Tachycardia, Diarrhoea, Vomiting, Convulsion, Pain, Cardiac Arrest
Patient was taking Zopiclone. After Zopiclone was administered, patient encountered several Zopiclone side effects: torsade de pointes, ventricular tachycardia, diarrhoea, vomiting, convulsion, pain, cardiac arrest on Jun 15, 2012 from UNITED KINGDOM Additional patient health information: Male , 47 years of age, weighting 201.9 lb, was diagnosed with and. Zopiclone dosage: Unk.
Multiple concurrent drugs taken:
  • Propranolol Hcl (10 Mg, 2x/day)
  • Gabapentin
  • Oramorph Sr
  • Sunitinib Malate (50 Mg, 1x/day)
  • Morphine
  • Prozac
Patient was hospitalized.

Memory Impairment
Adverse event was reported on Jun 07, 2012 by a Female taking Zopiclone (zopiclone) (Dosage: N/A) . Location: DENMARK , 26 years of age, Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: memory impairment.
Associated medications used:
  • Diazepam (5 Mg;tid)
  • Kadian


Folliculitis, Hypertrichosis, Application Site Reaction, Application Site Ulcer, Eczema, Lethargy, Urine Analysis Abnormal, Pollakiuria, Neurodermatitis
on Jun 20, 2012 Male from CANADA , weighting 179.0 lb, was diagnosed with and was treated with Zopiclone. Patient felt the following Zopiclone side effects: folliculitis, hypertrichosis, application site reaction, application site ulcer, eczema, lethargy, urine analysis abnormal, pollakiuria, neurodermatitis. Zopiclone dosage: N/A.
Multiple prescriptions taken:
  • Minoxidil
Patient was hospitalized.

Acute Respiratory Failure, Pyrexia, Malaise, Renal Impairment, Cough, Pneumonia, Electrocardiogram Qt Prolonged, Pleural Effusion, Hypokalaemia
on Jun 19, 2012 Male from JAPAN , 75 years of age, was treated with Zopiclone. After Zopiclone was administered, patient encountered several Zopiclone side effects: acute respiratory failure, pyrexia, malaise, renal impairment, cough, pneumonia, electrocardiogram qt prolonged, pleural effusion, hypokalaemia. Zopiclone dosage: 75 Mg,.
Multiple concurrent drugs taken:
  • 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,)
Patient was hospitalized.

Hysterectomy, Pelvic Mass, Ovarian Cancer, Salpingo-oophorectomy
Patient was taking Zopiclone. Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: hysterectomy, pelvic mass, ovarian cancer, salpingo-oophorectomy on Jun 16, 2012 from CANADA Additional patient health information: Female , weighting 163.1 lb, was diagnosed with and. Zopiclone dosage: N/A.
Associated medications used:
  • Perindopril Erbumine
  • Hydrochlorothiazide
  • Trazodone Hcl
  • Remicade (37th Infusion)
  • Methotrexate (1 Cc)
  • Desloratadine
  • Solu-cortef
  • Remicade
Patient was hospitalized.

Respiratory Arrest, Pneumonia Aspiration
Adverse event was reported on Jun 05, 2012 by a Male taking Zopiclone (zopiclone) (Dosage: 7.5 Mg;qd;po) was diagnosed with and. Location: DENMARK , 47 years of age, Patient felt the following Zopiclone side effects: respiratory arrest, pneumonia aspiration.
Multiple prescriptions taken:
  • Nitrazepam (Po)
  • Olanzapine
  • Lorazepam (1 Mg;prn;po)
  • Clozaril (Po)
Patient was hospitalized.

Dyskinesia, Syncope, Muscle Rigidity, Convulsion
on Jun 21, 2012 Male from UNITED KINGDOM , 29 years of age, weighting 119.0 lb, was diagnosed with and was treated with Zopiclone. After Zopiclone was administered, patient encountered several Zopiclone side effects: dyskinesia, syncope, muscle rigidity, convulsion. Zopiclone dosage: 7.5 Mg, Qd.
Multiple concurrent drugs taken:
  • Acetaminophen (1 G, Qid)
  • Clopixol (100 Mg Daily)
  • Lorazepam (1 Mg, Qid)
  • Tramadol Hcl
  • Olanzapine (5 Mg, Bid)
  • Codeine (60 Mg, Qid)


Aortic Aneurysm, Spinal Column Stenosis
on Jun 13, 2012 Female from CANADA , weighting 185.2 lb, was treated with Zopiclone. Directly after, patient experienced the unwanted or unexpected Zopiclone side effects: aortic aneurysm, spinal column stenosis. Zopiclone dosage: N/A.
Associated medications used:
  • Magnesium
  • Folic Acid
  • Ascorbic Acid
  • Remicade
  • Methotrexate
Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • 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


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  • 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.

    Discuss Zopiclone Side Effects

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    Safety Alerts, Active Ingredients, Usage Information

    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]

    Latest Zopiclone clinical trials