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Ambien CR (Zolpidem) - Side Effects & Adverse Reactions Reported to FDA

 



This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Ambien CR (Zolpidem). Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.

Our database includes reports primarily from April 2009 to March 2010. The information is not vetted and should not be cosidered as verified clinical evidence.

All cases (147)
     Amnesia (69)Somnambulism (67)Road Traffic Accident (36)more >>

Cases resulting in a serious event (138)
     Amnesia (65)Somnambulism (65)Road Traffic Accident (36)more >>

Cases resulting in death (10)
     Completed Suicide (5)GUN Shot Wound (3)Somnambulism (3)more >>

Cases resulting in life threatening events (18)
     Amnesia (13)Somnambulism (10)Road Traffic Accident (8)more >>

Cases resulting in hospitalization (39)
     Somnambulism (20)Amnesia (15)Fall (13)more >>

Cases resulting in disability (9)
     Fall (8)Somnambulism (8)Back Pain (7)more >>

Cases resulting in other serious reactions (96)
     Amnesia (51)Somnambulism (50)Road Traffic Accident (26)more >>

Below is a sample of reports where side effects / adverse reactions may be related to Ambien CR (Zolpidem). For a complete list and/or a specific selection of reports, please use the links in the index above.

Possible Ambien CR side effects / adverse reactions in 67 year old female

Reported by a consumer/non-health professional from United States on 2010-03-31

Patient: 67 year old female

Reactions: Concussion, Wrist Fracture, Pain, Somnambulism, Fall, Amnesia, Open Wound

Suspect drug(s):
Ambien CR

Other drugs received by patient: ALL Other Therapeutic Products



Possible Ambien CR side effects / adverse reactions in 43 year old male

Reported by a physician from United States on 2010-03-31

Patient: 43 year old male

Reactions: Somnambulism, Self Injurious Behaviour, Amnesia, Aggression

Suspect drug(s):
Ambien CR

Other drugs received by patient: Effexor; Serotonin Antagonists



Possible Ambien CR side effects / adverse reactions in female

Reported by a consumer/non-health professional from United States on 2010-03-30

Patient: female

Reactions: Skin Laceration, Somnambulism, Fall, Sleep-Related Eating Disorder

Suspect drug(s):
Ambien CR



Possible Ambien CR side effects / adverse reactions in 67 year old female

Reported by a consumer/non-health professional from United States on 2010-03-29

Patient: 67 year old female

Reactions: Concussion, Upper Limb Fracture, Pain, Somnambulism, Fall, Amnesia, Open Wound

Suspect drug(s):
Ambien CR

Other drugs received by patient: ALL Other Therapeutic Products



Possible Ambien CR side effects / adverse reactions in female

Reported by a consumer/non-health professional from United States on 2010-03-29

Patient: female

Reactions: Movement Disorder, Wrong Technique in Drug Usage Process, Pain, Therapeutic Response Unexpected, Drug Withdrawal Syndrome, OFF Label USE, Insomnia, Gallbladder Disorder, Drug Dependence

Suspect drug(s):
Ambien CR
    Administration route: Oral
    Indication: Sleep Disorder

Ambien CR
    Administration route: Oral
    Indication: Pain Management

Ambien CR
    Dosage: consumer takes 1/2 or part of of the tablet during the day
    Administration route: Oral

Ambien CR
    Dosage: consumer takes 1/2 or part of of the tablet during the day
    Administration route: Oral

Other drugs received by patient: ALL Other Therapeutic Products



Possible Ambien CR side effects / adverse reactions in 68 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2010-03-23

Patient: 68 year old male, weighing 117.9 kg (259.4 pounds)

Reactions: Brain Compression, Head Injury, Intentional Drug Misuse, Pyrexia, Fall, Loss of Consciousness, Subdural Haematoma, Visual Midline Shift Syndrome, Pupil Fixed, Oxygen Saturation Decreased, Excoriation, Hypotension, Subcutaneous Haematoma, Skin Laceration, Subarachnoid Haemorrhage, Cerebral Infarction, Miosis, Knee Deformity, Skull Fractured Base, Depressed Level of Consciousness, Somnambulism

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Ambien CR
    Administration route: Oral
    Start date: 2006-10-01

Ambien
    Dosage: dose text: one tablet at bedtime as neededunit dose: 10 mg
    Administration route: Oral
    Start date: 2006-02-01
    End date: 2006-01-01

Ambien
    Administration route: Oral

Plavix
    Dosage: unit dose: 75 mg
    Administration route: Oral
    Indication: Coronary Artery Disease

Clopidogrel
    Administration route: Oral
    Indication: Coronary Artery Disease
    Start date: 2006-10-01

Ecotrin
    Dosage: unit dose: 375 mg
    Indication: Coronary Artery Disease

Other drugs received by patient: Tricor; Altace; Norvasc; Toprol-XL; Viagra; Benzonatate



Possible Ambien CR side effects / adverse reactions in 67 year old female

Reported by a consumer/non-health professional from United States on 2010-03-18

Patient: 67 year old female

Reactions: Concussion, Upper Limb Fracture, Somnambulism, Open Wound, Amnesia, Fall

Suspect drug(s):
Ambien CR

Other drugs received by patient: ALL Other Therapeutic Products



Possible Ambien CR side effects / adverse reactions in 68 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2010-03-18

Patient: 68 year old male, weighing 117.9 kg (259.4 pounds)

Reactions: Brain Compression, Head Injury, Intentional Drug Misuse, Pyrexia, Fall, Loss of Consciousness, Subdural Haematoma, Visual Midline Shift Syndrome, Pupil Fixed, Oxygen Saturation Decreased, Excoriation, Hypotension, Subcutaneous Haematoma, Skin Laceration, Subarachnoid Haemorrhage, Cerebral Infarction, Miosis, Knee Deformity, Skull Fractured Base, Depressed Level of Consciousness, Somnambulism

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Ambien CR
    Administration route: Oral
    Start date: 2006-10-01

Ambien
    Dosage: dose text: one tablet at bedtime as neededunit dose: 10 mg
    Administration route: Oral
    Start date: 2006-02-01
    End date: 2006-01-01

Ambien
    Administration route: Oral

Plavix
    Dosage: unit dose: 75 mg
    Administration route: Oral
    Indication: Coronary Artery Disease

Clopidogrel
    Administration route: Oral
    Indication: Coronary Artery Disease
    Start date: 2006-10-01

Ecotrin
    Dosage: unit dose: 375 mg
    Indication: Coronary Artery Disease

Other drugs received by patient: Tricor; Altace; Norvasc; Toprol-XL; Viagra; Benzonatate



Possible Ambien CR side effects / adverse reactions in 52 year old female

Reported by a physician from United States on 2010-03-09

Patient: 52 year old female, weighing 81.7 kg (179.6 pounds)

Reactions: Back Pain, Dyspnoea, Neurogenic Bladder, Spinal Fracture, Hypoaesthesia, Fall, Haemoglobin Decreased, Paraplegia, Traumatic Lung Injury, Urinary Retention, Somnambulism, Altered State of Consciousness, Neuralgia

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Ambien CR

Other drugs received by patient: Lexapro; Robaxin; Diphenhydramine / Paracetamol; Ativan



Possible Ambien CR side effects / adverse reactions in 71 year old female

Reported by a consumer/non-health professional from United States on 2010-03-09

Patient: 71 year old female, weighing 99.8 kg (219.6 pounds)

Reactions: Suture Rupture, LIP Swelling, Contusion, Haemorrhage, Fall, Feeling Abnormal

Suspect drug(s):
Ambien CR

Other drugs received by patient: Verapamil; Lisinopril; Propranolol Hydrochloride; Glyburide; Simvastatin; Oxybutynin



Possible Ambien CR side effects / adverse reactions in 43 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2010-03-09

Patient: 43 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Liver Injury, Contusion, Sensory Loss, Hyperhidrosis, Abdominal Discomfort, Thinking Abnormal, Osteomyelitis Fungal, Orchitis, Peroneal Nerve Palsy, Intestinal Functional Disorder, Acute Respiratory Distress Syndrome, Pneumothorax, Pupil Fixed, Back Pain, Joint Injury, Delirium, Irritability, Post-Traumatic Stress Disorder, Intervertebral Disc Space Narrowing, Ventricular Tachycardia, Somnambulism, Back Injury, Intraspinal Abscess, Abasia, Fall, Weight Bearing Difficulty, Impaired Driving Ability, Overdose, Chest Pain, Oedema, Dyspnoea, Anoxic Encephalopathy, Ear Infection, Nerve Compression, Alcohol Poisoning, Dysstasia, Lung Disorder, Drowning, Sepsis, Testicular Pain, Cauda Equina Syndrome, Respiratory Arrest, Bladder Disorder, Gait Disturbance, Asthenia, Drug Dependence, Testicular Cyst, Personality Change, Pneumonia Aspiration, Osteomyelitis, Impulsive Behaviour, Treatment Noncompliance, Loss of Consciousness, Delusion, Hypoxia, Urinary Retention, Blood Pressure Abnormal, Cough, Intervertebral Disc Protrusion, Anxiety Disorder, Hypothermia, Pain in Extremity, Abnormal Behaviour, Major Depression, Disturbance in Attention, Nerve Injury, Soft Tissue Disorder, Drug Ineffective, Drug Abuse, Suicidal Ideation, Endodontic Procedure, Fatigue, Road Traffic Accident, Intervertebral Discitis, Pneumothorax Traumatic, Hallucination, Respiratory Tract Infection Bacterial, Post Concussion Syndrome, Motor Dysfunction, Incorrect Dose Administered, Brain Contusion, Cognitive Disorder, Amnesia, Traumatic Brain Injury, Respiratory Failure, Joint Sprain, Cardiac Arrest, Sinus Tachycardia

Adverse event resulted in: life threatening event, hospitalization, disablity

Suspect drug(s):
Ambien
    Dosage: unit dose: 10 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2004-01-01

Ambien
    Administration route: Oral

Ambien CR
    Dosage: unit dose: 12.5 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-01-01

Novocain
    Start date: 2006-09-21

Darvocet-N 100

Other drugs received by patient: Wellbutrin; Cymbalta; Celebrex; Valtrex; Tagamet; Ultram; Lortab; Lortab; Lortab; Flexeril; Tylenol (Caplet); Tylenol (Caplet); Pseudoephedrine HCL; Oxycontin; Ventolin; Flonase; Albuterol; Allegra



Possible Ambien CR side effects / adverse reactions in 38 year old female

Reported by a consumer/non-health professional from United States on 2010-03-05

Patient: 38 year old female

Reactions: Contusion, Sleep Talking, Fall, Amnesia, Sleep-Related Eating Disorder, Periorbital Haematoma, Weight Increased, Burns Third Degree, Somnambulism, Feeling Abnormal

Suspect drug(s):
Ambien CR



Possible Ambien CR side effects / adverse reactions in 52 year old female

Reported by a physician from United States on 2010-03-05

Patient: 52 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Back Pain, Dyspnoea, Neurogenic Bladder, Spinal Fracture, Fall, Paraplegia, Haemoglobin Decreased, Traumatic Lung Injury, Urinary Retention, Somnambulism, Altered State of Consciousness, Neuralgia

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Ambien CR

Other drugs received by patient: Lexapro; Robaxin; Diphenhydramine / Paracetamol; Ativan



Possible Ambien CR side effects / adverse reactions in female

Reported by a health professional (non-physician/pharmacist) from United States on 2010-03-03

Patient: female, weighing 78.4 kg (172.5 pounds)

Reactions: Blood Pressure Increased, Osteoporosis, Pain, Internal Fixation of Fracture, HIP Fracture, Cardiac Valve Disease, Reflux Oesophagitis, Catheterisation Cardiac, Atrioventricular Block, Sarcoidosis

Suspect drug(s):
Femara
    Dosage: 2.5 mg, qd
    Administration route: Oral
    Indication: Breast Cancer Female
    Start date: 2006-07-20

Ambien CR

Other drugs received by patient: Alprazolam; Oxycodon; Zolpidem; Diclofenac Sodium; Atorvastatin Calcium; Citalopram Hydrobromide; Simvastatin; Ropinirole; Omeprazole; Dulcolax; Lisinopril; Fentanyl-100; Aspirin; Teriparatide



Possible Ambien CR side effects / adverse reactions in 52 year old female

Reported by a physician from United States on 2010-03-01

Patient: 52 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Back Pain, Dyspnoea, Neurogenic Bladder, Spinal Fracture, Fall, Paraplegia, Haemoglobin Decreased, Traumatic Lung Injury, Urinary Retention, Somnambulism, Altered State of Consciousness, Neuralgia

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Ambien CR

Other drugs received by patient: Lexapro; Robaxin; Diphenhydramine / Paracetamol; Ativan



Possible Ambien CR side effects / adverse reactions in female

Reported by a consumer/non-health professional from United States on 2010-02-23

Patient: female

Reactions: HIP Fracture, Fall

Suspect drug(s):
Ambien CR



Possible Ambien CR side effects / adverse reactions in 71 year old female

Reported by a consumer/non-health professional from United States on 2010-02-22

Patient: 71 year old female, weighing 99.8 kg (219.6 pounds)

Reactions: LIP Swelling, Contusion, Haemorrhage, Feeling Abnormal, Fall

Suspect drug(s):
Ambien CR

Other drugs received by patient: Antihypertensives; ALL Other Therapeutic Products



Possible Ambien CR side effects / adverse reactions in 31 year old male

Reported by a physician from United States on 2010-02-22

Patient: 31 year old male, weighing 85.7 kg (188.6 pounds)

Reactions: Sexual Abuse, Therapeutic Response Decreased, Drug Ineffective, Somnambulism, Amnesia

Suspect drug(s):
Zolpidem Tartrate
    Dosage: unit dose: mg
    Administration route: Oral
    Indication: Sleep Disorder
    End date: 2004-08-01

Ambien CR

Other drugs received by patient: Alcohol; Herbal Preparation; Restoril; Lexapro; Celexa



Possible Ambien CR side effects / adverse reactions in 52 year old female

Reported by a physician from United States on 2010-02-22

Patient: 52 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Back Pain, Dyspnoea, Neurogenic Bladder, Spinal Fracture, Fall, Paraplegia, Traumatic Lung Injury, Urinary Retention, Somnambulism, Altered State of Consciousness, Neuralgia

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Ambien CR

Other drugs received by patient: Lexapro; Robaxin; Diphenhydramine / Paracetamol



Possible Ambien CR side effects / adverse reactions in 43 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2010-02-16

Patient: 43 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Personality Change, Pneumonia Aspiration, Contusion, Osteomyelitis, Hyperhidrosis, Loss of Consciousness, Delusion, Abdominal Discomfort, Osteomyelitis Fungal, Thinking Abnormal, Peroneal Nerve Palsy, Hypoxia, Acute Respiratory Distress Syndrome, Intestinal Functional Disorder, Pneumothorax, Pupil Fixed, Urinary Retention, Intervertebral Disc Protrusion, Back Pain, Anxiety Disorder, Pain in Extremity, Hypothermia, Delirium, Joint Injury, Irritability, Intervertebral Disc Space Narrowing, Post-Traumatic Stress Disorder, Ventricular Tachycardia, Disturbance in Attention, Somnambulism, Drug Ineffective, Abasia, Fall, Drug Abuse, Suicidal Ideation, Impaired Driving Ability, Fatigue, Road Traffic Accident, Chest Pain, Oedema, Hallucination, Dyspnoea, Post Concussion Syndrome, Anoxic Encephalopathy, Brain Contusion, Cognitive Disorder, Amnesia, Traumatic Brain Injury, Lung Disorder, Respiratory Failure, Drowning, Sepsis, Testicular Pain, Cauda Equina Syndrome, Respiratory Arrest, Bladder Disorder, Gait Disturbance, Asthenia, Cardiac Arrest, Sinus Tachycardia

Adverse event resulted in: life threatening event, hospitalization, disablity

Suspect drug(s):
Ambien
    Dosage: unit dose: 10 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2004-01-01

Ambien
    Administration route: Oral

Ambien CR
    Dosage: unit dose: 12.5 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-01-01

Novocain
    Start date: 2006-09-21

Darvocet-N 100

Other drugs received by patient: Wellbutrin; Cymbalta; Celebrex; Valtrex; Tagamet; Ultram; Lortab; Lortab; Lortab; Flexeril; Tylenol (Caplet); Tylenol (Caplet); Pseudoephedrine; Oxycontin; Ventolin; Flonase; Albuterol; Allegra



Possible Ambien CR side effects / adverse reactions in 67 year old male

Reported by a consumer/non-health professional from United States on 2010-02-09

Patient: 67 year old male

Reactions: Therapeutic Response Decreased, Insomnia, Drug Interaction, Somnolence

Suspect drug(s):
Paxil
    Indication: Drug USE FOR Unknown Indication
    Start date: 1989-01-01

Ambien CR
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication
    Start date: 2007-01-01



Possible Ambien CR side effects / adverse reactions in 43 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2010-02-04

Patient: 43 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Personality Change, Contusion, Pneumonia Aspiration, Osteomyelitis, Hyperhidrosis, Loss of Consciousness, Delusion, Abdominal Discomfort, Thinking Abnormal, Peroneal Nerve Palsy, Pneumothorax, Hypoxia, Intestinal Functional Disorder, Acute Respiratory Distress Syndrome, Pupil Fixed, Urinary Retention, Back Pain, Intervertebral Disc Protrusion, Anxiety Disorder, Pain in Extremity, Hypothermia, Delirium, Joint Injury, Irritability, Post-Traumatic Stress Disorder, Intervertebral Disc Space Narrowing, Ventricular Tachycardia, Disturbance in Attention, Somnambulism, Abasia, Fall, Drug Abuse, Suicidal Ideation, Impaired Driving Ability, Road Traffic Accident, Chest Pain, Oedema, Hallucination, Dyspnoea, Anoxic Encephalopathy, Post Concussion Syndrome, Brain Contusion, Cognitive Disorder, Amnesia, Traumatic Brain Injury, Lung Disorder, Drowning, Respiratory Failure, Sepsis, Respiratory Arrest, Cauda Equina Syndrome, Bladder Disorder, Gait Disturbance, Sinus Tachycardia, Asthenia, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization, disablity

Suspect drug(s):
Ambien
    Dosage: unit dose: 10 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2004-01-01

Ambien
    Administration route: Oral

Ambien CR
    Dosage: unit dose: 12.5 mg
    Administration route: Oral
    Indication: Insomnia
    Start date: 2006-01-01

Novocain
    Start date: 2006-09-21

Darvocet-N 100

Other drugs received by patient: Wellbutrin; Cymbalta; Celebrex; Valtrex; Tagamet; Ultram; Lortab; Lortab; Lortab; Flexeril; Tylenol (Caplet); Tylenol (Caplet); Pseudoephedrine; Oxycontin; Ventolin; Flonase; Albuterol; Allegra



Possible Ambien CR side effects / adverse reactions in 41 year old female

Reported by a physician from United States on 2010-01-27

Patient: 41 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Anger, Somnambulism, Hallucination, Delusion, Loss of Consciousness

Suspect drug(s):
Abilify
    Dosage: decreased to 15mg(qd)
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-10-01

Abilify
    Dosage: decreased to 15mg(qd)
    Administration route: Oral
    Indication: Depression
    Start date: 2009-10-01

Ambien CR

Other drugs received by patient: Lithium; Xanax; Tylenol PM; Ambien; Multi-Vitamins; Black Cohosh; Adderall 10



Possible Ambien CR side effects / adverse reactions in female

Reported by a consumer/non-health professional from United States on 2010-01-22

Patient: female

Reactions: Weight Increased, Impaired Driving Ability, Road Traffic Accident, Sleep-Related Eating Disorder

Suspect drug(s):
Ambien CR



Possible Ambien CR side effects / adverse reactions in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2010-01-19

Patient: 56 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Contusion, Somnambulism, Fall, Amnesia, Hallucination, Eating Disorder

Suspect drug(s):
Ambien CR

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