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Ambien CR (Zolpidem) - Side Effect Reports to FDA

 
 



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: Confusional State, Automatism, Accidental Exposure

Drug(s) suspected as cause:
Ambien

Ambien CR

Zolpidem



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 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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