This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ambien CR (Zolpidem) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (43)
Disability (2)
Reports by Reaction Type
Drug Ineffective (10),
Somnambulism (9),
Road Traffic Accident (8),
Drug Abuse (6),
Abnormal Behaviour (6),
Amnesia (6),
Intentional Overdose (5),
Product Quality Issue (5),
Prostate Cancer (5),
Headache (4),
Condition Aggravated (4),
Abdominal Pain (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Ambien CR (Zolpidem). For a complete list or a specific selection of reports, please use the links above.
Possible Ambien CR side effects in 45 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient: 45 year old female
Reactions: Abnormal Sleep-Related Event
Drug(s) suspected as cause:
Ambien CR
Other drugs received by patient: Wellbutrin SR; Adderall
Possible Ambien CR side effects in 56 year old male
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: 56 year old male, weighing 108.9 kg (239.5 pounds)
Reactions: Peripheral Coldness, Blood Pressure Increased, Vomiting, Muscular Weakness, Headache, Anxiety, Incontinence, DRY Mouth, Chest Pain, Heart Rate Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien CR
Dosage: one at night po
Administration route: Oral
Indication: Sleep Disorder
Start date: 2012-05-27
End date: 2012-06-27
Ambien CR
Dosage: one at night po
Administration route: Oral
Indication: Pain
Start date: 2012-05-27
End date: 2012-06-27
Ambien
Dosage: one at nigh po
Administration route: Oral
Indication: Sleep Disorder
Start date: 2012-08-10
End date: 2012-08-15
Ambien
Dosage: one at nigh po
Administration route: Oral
Indication: Pain
Start date: 2012-08-10
End date: 2012-08-15
Possible Ambien CR side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-10
Patient: male, weighing 79.4 kg (174.6 pounds)
Reactions: Abdominal Pain, Headache, Weight Increased, Palpitations, Chest Pain, Dizziness, Abnormal Loss of Weight, Hypersomnia, Decreased Appetite, Nausea, Breakthrough Pain, Middle Insomnia, Diarrhoea, Oesophageal Disorder, Withdrawal Syndrome, Asthenia, Hypertension
Drug(s) suspected as cause:
Ambien CR
Administration route: Oral
Indication: Sleep Disorder
Start date: 2010-01-01
End date: 2012-07-01
Fentanyl-100
Dosage: ndc 0781-7244-55
Indication: Intervertebral Disc Degeneration
Start date: 2012-07-06
Fentanyl-100
Dosage: 2 50 mcg patch (ndc-0781-7221-55)
Start date: 2012-01-19
Other drugs received by patient: Buspar; Propranolol; Klor-CON; Fish OIL; Clonidine; Percocet; Inderal; Protonix; Nexium
Possible Ambien CR side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Provigil
Zetia
Administration route: Oral
Zocor
Administration route: Oral
Arthrotec
Administration route: Oral
Livalo
Ambien CR
Lipitor
Administration route: Oral
Sulfamethoxazole
Cefzil
PCE
Amoxicillin
Dosage: 0.5, qd
Pravachol
Oxacillin Sodium
Biaxin
Ultram
Lortab
Possible Ambien CR side effects in male
Reported by a physician from United States on 2012-06-29
Patient: male
Reactions: Product Substitution Issue, Drug Ineffective, Nausea, Headache
Drug(s) suspected as cause:
Ambien CR
Indication: Insomnia
Start date: 2011-12-01
Ambien CR Sandoz
Indication: Depression
Start date: 2012-06-01
Possible Ambien CR side effects in 55 year old female
Reported by a pharmacist from United States on 2012-06-27
Patient: 55 year old female, weighing 63.2 kg (139.0 pounds)
Reactions: Dysarthria, Confusional State, Unresponsive To Stimuli, Catatonia, Respiratory Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien CR
Other drugs received by patient: Meclizine; Dyazide
Possible Ambien CR side effects in female
Reported by a physician from United States on 2012-06-26
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Arthrotec
Dosage: unk
Administration route: Oral
Sulfamethoxazole
Dosage: unk
Ultram
Dosage: unk
Lipitor
Dosage: unk
Administration route: Oral
Lortab
Dosage: unk
Pravachol
Dosage: unk
Oxacillin Sodium
Dosage: unk
PCE
Dosage: unk
Zetia
Dosage: unk
Ambien CR
Dosage: unk
Amoxicillin
Dosage: 0.5 unk, 1x/day
Biaxin
Dosage: unk
Cefzil
Dosage: unk
Zocor
Dosage: unk
Livalo
Dosage: unk
Provigil
Dosage: unk
Possible Ambien CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female
Reactions: Neoplasm Malignant
Drug(s) suspected as cause:
Ambien CR
Possible Ambien CR side effects in 59 year old female
Reported by a physician from United States on 2012-06-08
Patient: 59 year old female, weighing 138.8 kg (305.4 pounds)
Reactions: Aphasia, Condition Aggravated, Cognitive Disorder, Amnesia, Tremor
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Zolpidem
Dosage: 10mg 1 time at bedtime po
Administration route: Oral
Indication: Insomnia
Start date: 2011-07-13
End date: 2011-11-08
Ambien CR
Dosage: 12.5mg 1 time at bedtime po
Administration route: Oral
Indication: Insomnia
Start date: 2011-02-16
End date: 2011-07-12
Possible Ambien CR side effects in
Reported by a physician from United States on 2012-06-04
Patient:
Reactions: Road Traffic Accident
Drug(s) suspected as cause:
Ambien CR
Possible Ambien CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient: female
Reactions: Myocardial Infarction
Drug(s) suspected as cause:
Zolpidem Tartrate
Ambien CR
Possible Ambien CR side effects in 40 year old female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: 40 year old female
Reactions: Fatigue, Drug Ineffective, Insomnia, Incorrect Dose Administered, Breast Mass, Drug Dependence, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien
Indication: Insomnia
Ambien CR
Indication: Insomnia
ALL Other Therapeutic Products
Start date: 2012-05-01
Other drugs received by patient: MS Contin
Possible Ambien CR side effects in 69 year old female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: 69 year old female
Reactions: Localised Infection, Drug Ineffective, Drug Interaction
Drug(s) suspected as cause:
Amitriptyline Hydrochloride
Indication: Insomnia
Antibiotics
Indication: Infection
Start date: 2011-01-01
Ambien CR
Administration route: Oral
Indication: Sleep Disorder
Start date: 2010-03-01
Gabapentin
Zolpidem Tartrate
Administration route: Oral
Indication: Sleep Disorder
Possible Ambien CR side effects in 33 year old male
Reported by a physician from United States on 2012-05-18
Patient: 33 year old male
Reactions: Mental Impairment, Speech Disorder, Balance Disorder, Somnambulism, Lacrimation Increased
Drug(s) suspected as cause:
Ambien CR
Indication: Insomnia
Start date: 2008-07-01
Diphenhydramine HCL
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Pain Medications (Nos)
Possible Ambien CR side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-16
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Nightmare, Abnormal Behaviour, Rash, Amnesia, Loss of Consciousness, Irritability, Disturbance in Attention, Vision Blurred, Divorced, Mood Swings, Heart Rate Irregular
Drug(s) suspected as cause:
Ambien CR
Possible Ambien CR side effects in 69 year old female
Reported by a consumer/non-health professional from United States on 2012-05-11
Patient: 69 year old female
Reactions: Localised Infection, Drug Ineffective, Drug Interaction
Drug(s) suspected as cause:
Ambien CR
Administration route: Oral
Indication: Sleep Disorder
Start date: 2010-03-01
Gabapentin
Antibiotics
Indication: Infection
Start date: 2011-01-01
Zolpidem Tartrate
Administration route: Oral
Indication: Sleep Disorder
Amitriptyline HCL
Indication: Insomnia
Possible Ambien CR side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-04
Patient: 54 year old male
Reactions: Somnambulism
Drug(s) suspected as cause:
Levetiracetam
Paroxetine
Trazodone HCL
Ambien CR
Dosage: 12.5 mg
Gabapentin
Possible Ambien CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-26
Patient: female
Reactions: Weight Decreased, Muscle Atrophy, Condition Aggravated, Helicobacter Infection, Gastrointestinal Ulcer, Fibromyalgia, Diarrhoea, Raynaud's Phenomenon
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien CR
Administration route: Oral
Indication: Insomnia
Ambien
Indication: Insomnia
Start date: 2004-01-01
Other drugs received by patient: Valsartan; ALL Other Therapeutic Products; Synthroid; Nebivolol; Amlodipine
Possible Ambien CR side effects in male
Reported by a pharmacist from United States on 2012-04-25
Patient: male
Reactions: Road Traffic Accident, Somnambulism, Drug Abuse, Amnesia
Drug(s) suspected as cause:
Ambien CR
Ambien CR
Start date: 2011-05-07
End date: 2011-05-07
Other drugs received by patient: Simvastatin; Multi-Vitamins; Fish OIL; Adderall 5; Aspirin; Metformin HCL; Lisinopril
Possible Ambien CR side effects in 59 year old female
Reported by a consumer/non-health professional from United States on 2012-04-25
Patient: 59 year old female, weighing 83.9 kg (184.6 pounds)
Reactions: Neuropathy Peripheral
Drug(s) suspected as cause:
Ambien
Dosage: 10 mg 1 per nite tablet about 1 mo. 2010 or 2009
Indication: Insomnia
Ambien CR
Dosage: 10 mg 1 per nite tablet about 1 mo. 2010 or 2009
Possible Ambien CR side effects in 80 year old female
Reported by a consumer/non-health professional from United States on 2012-04-16
Patient: 80 year old female
Reactions: Gallbladder Disorder, Gastrooesophageal Reflux Disease, Gastritis
Drug(s) suspected as cause:
Ambien CR
Administration route: Oral
Start date: 2005-01-01
Ambien CR
Administration route: Oral
Ambien
Administration route: Oral
Start date: 2004-01-01
End date: 2004-01-01
Ambien
Administration route: Oral
Indication: Anxiety
Start date: 2004-01-01
End date: 2004-01-01
Ambien CR
Administration route: Oral
Indication: Anxiety
Start date: 2005-01-01
Ambien CR
Administration route: Oral
Possible Ambien CR side effects in 57 year old male
Reported by a physician from United States on 2012-04-13
Patient: 57 year old male
Reactions: Product Quality Issue, Road Traffic Accident, Intentional Overdose, Drug Ineffective, Prostate Cancer, Abnormal Behaviour, Sleep Talking, Somnambulism, Drug Abuse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien
Administration route: Oral
Start date: 2003-01-01
End date: 2010-01-01
Zolpidem Tartrate
Ambien CR
Administration route: Oral
Ambien
Administration route: Oral
Start date: 2012-02-01
End date: 2012-02-01
Ambien
Administration route: Oral
Start date: 2010-01-01
End date: 2012-01-01
Other drugs received by patient: VIT C; Remeron; Protonix; Xanax; Lunesta; Zoloft; Vitamin B-12; Proventil; Uniretic; Trazodone HCL
Possible Ambien CR side effects in 80 year old male
Reported by a physician from Israel on 2012-04-11
Patient: 80 year old male
Reactions: Abdominal Pain, Vomiting, Hyponatraemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien CR
Other drugs received by patient: Beta Blocking Agents; Calcium Channel Blockers; ACE Inhibitor NOS
Possible Ambien CR side effects in 80 year old male
Reported by a physician from Israel on 2012-04-11
Patient: 80 year old male
Reactions: Abdominal Pain, Vomiting, Hyponatraemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien CR
Other drugs received by patient: Beta Blocking Agents; Calcium Channel Blockers; ACE Inhibitor NOS
Possible Ambien CR side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-30
Patient:
Reactions: Poisoning
Drug(s) suspected as cause:
Ambien CR
Ambien
Zolpidem
Possible Ambien CR side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-30
Patient:
Reactions: Confusional State, Automatism, Accidental Exposure
Drug(s) suspected as cause:
Ambien
Ambien CR
Zolpidem
Possible Ambien CR side effects in 57 year old male
Reported by a physician from United States on 2012-03-28
Patient: 57 year old male
Reactions: Product Quality Issue, Road Traffic Accident, Drug Ineffective, Intentional Overdose, Prostate Cancer, Sleep Talking, Abnormal Behaviour, Somnambulism, Drug Abuse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien
Administration route: Oral
Start date: 2003-01-01
End date: 2010-01-01
Ambien
Administration route: Oral
Start date: 2012-02-01
End date: 2012-02-01
Ambien CR
Administration route: Oral
Ambien
Administration route: Oral
Start date: 2010-01-01
End date: 2012-01-01
Zolpidem Tartrate
Other drugs received by patient: Trazodone HCL; Protonix; Xanax; Lunesta; Zoloft; Uniretic; VIT C; Proventil; Remeron; Vitamin B-12
Possible Ambien CR side effects in 33 year old male
Reported by a physician from United States on 2012-03-28
Patient: 33 year old male
Reactions: Road Traffic Accident, Somnambulism, Amnesia, Sleep-Related Eating Disorder
Drug(s) suspected as cause:
Ambien CR
Dosage: took one 12.5mg ambien cr on night of sleep driving incident
Administration route: Oral
Indication: Insomnia
Zolpidem
Dosage: 10mg
Indication: Insomnia
Possible Ambien CR side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient: female
Reactions: Weight Decreased, Muscle Atrophy, Condition Aggravated, Helicobacter Infection, Gastrointestinal Ulcer, Diarrhoea, Fibromyalgia, Raynaud's Phenomenon
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien
Indication: Insomnia
Start date: 2004-01-01
Ambien CR
Administration route: Oral
Indication: Insomnia
Other drugs received by patient: Synthroid
Possible Ambien CR side effects in 57 year old male
Reported by a physician from United States on 2012-03-22
Patient: 57 year old male
Reactions: Product Quality Issue, Road Traffic Accident, Drug Ineffective, Prostate Cancer, Intentional Overdose, Sleep Talking, Abnormal Behaviour, Somnambulism, Drug Abuse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zolpidem Tartrate
Ambien
Administration route: Oral
Start date: 2003-01-01
End date: 2010-01-01
Ambien
Administration route: Oral
Start date: 2010-01-01
End date: 2012-01-01
Ambien
Administration route: Oral
Start date: 2012-02-01
End date: 2012-02-01
Ambien CR
Administration route: Oral
Other drugs received by patient: Xanax; Remeron; Lunesta; Zoloft; Uniretic; Trazodone HCL; VIT C; Protonix; Vitamin B-12; Proventil
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