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Zolpidem Safety Alerts
Review Zolpidem Starting taking ambien 10mg 4-5 years ago for insomnia. One yr later View Zolpidem Adverse Event Reports: patient, 32 years of age, weighting 190.0 lb, was diagnosed with insomnia and took Zolpidem 1 Tablet 1 Time Daily Po Patient was hospitalized.

Learn What Others Think about Zolpidem Side Effects. Have Your experienced Zolpidem Side Effects? You are not alone. Many patients report unusual symptoms after using Zolpidem. This forum raises awareness about Zolpidem Side Effects.

What Are Your Zolpidem Side Effects
Elevated Sex Drive (3)
Myocardial Infarction (3)
Pyelonephritis (2)
Back Pain (1)
Chest Pain With ECG Changes (negative T Waves) Wit (1)
Hiccups (1)
Polyneuropathy (1)
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Common Zolpidem Side Effects

top 5 Zolpidem|Elevated s|Myocardial|Pyelonephr|Back pain|Chest pain|Hiccups|Polyneurop adverse effects

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Showing 1-25 of 1999 

Abdominal Discomfort, Dyspnoea, Oral Discomfort, Chest Discomfort (8489398-5)
on Jun 28, 2012 Female patient from UNITED STATES , 32 years of age, weighting 190.0 lb, was diagnosed with
  • insomnia
and was treated with Zolpidem(View Usage). Patient experienced the following unwanted or unexpected effects: abdominal discomfort, dyspnoea, oral discomfort, chest discomfort. Zolpidem dosage: 1 Tablet 1 Time Daily Po. Patient was hospitalized.

Dyspnoea, Somnolence, Suicide Attempt, Toxicity To Various Agents, Tachycardia, Oxygen Saturation Decreased, Fatigue (8482838-7)
Patient was taking Zolpidem (View Usage). Patient had the following side effects: dyspnoea, somnolence, suicide attempt, toxicity to various agents, tachycardia, oxygen saturation decreased, fatigue on Jun 14, 2012 from SWITZERLAND Additional patient health information: Female patient , 59 years of age, . Zolpidem dosage: 20 Df;once;po.
Patient was taking other medications: Patient was hospitalized.

Stevens-johnson Syndrome (8479566-0)
Adverse event was reported on Jun 18, 2012 by a Female patient taking Zolpidem (View Usage) (Dosage: N/A) . Location: JAPAN , 55 years of age, After Zolpidem was administered, patient had the following side effects: stevens-johnson syndrome.
Patient was taking other medications: Patient was hospitalized.

Dysarthria, Balance Disorder, Fatigue, Memory Impairment, Thinking Abnormal (8477905-8)
on Jun 21, 2012 Female patient from UNITED STATES , 59 years of age, was treated with Zolpidem Tartrate (View Usage). Patient experienced the following unwanted or unexpected effects: dysarthria, balance disorder, fatigue, memory impairment, thinking abnormal. Zolpidem Tartrate dosage: N/A.


Muscular Weakness, Mania, Vision Blurred, Sleep Disorder, Feeling Drunk, Tachyphrenia, Grandiosity (8477901-0)
on Jun 14, 2012 Male patient from UNITED STATES , 27 years of age, was diagnosed with
  • insomnia
and was treated with Zolpidem(View Usage). Patient had the following side effects: muscular weakness, mania, vision blurred, sleep disorder (sleep disorder Questions), feeling drunk, tachyphrenia, grandiosity. Zolpidem dosage: Unk.
Patient was taking other medications:

Haemorrhage, Vomiting, Depressed Level Of Consciousness, Somnambulism, Neuralgia, Concussion, Cervical Vertebral Fracture (8477191-9)
Patient was taking Zolpidem Tartrate (View Usage). After Zolpidem was administered, patient had the following side effects: haemorrhage, vomiting, depressed level of consciousness, somnambulism, neuralgia, concussion (concussion Questions), cervical vertebral fracture on Jun 25, 2012 from UNITED STATES Additional patient health information: Male patient , 79 years of age, weighting 190.0 lb, was diagnosed with
  • insomnia
and. Zolpidem Tartrate dosage: 1/4 Tablet Several Years Occasionall. Patient was hospitalized.

Fall, Grand Mal Convulsion (8475482-9)
Adverse event was reported on Jun 19, 2012 by a Male patient taking Zolpidem (View Usage) (Dosage: N/A) . Location: FRANCE , 50 years of age, Patient experienced the following unwanted or unexpected effects: fall (fall Questions), grand mal convulsion.
Patient was taking other medications: Patient was hospitalized.

Paraesthesia (8474852-2)
on Jun 19, 2012 Female patient from FRANCE , 77 years of age, was treated with Zolpidem (View Usage). Patient had the following side effects: paraesthesia. Zolpidem dosage: N/A.
Patient was taking other medications:

Rhabdomyolysis, Renal Failure Acute, Bradykinesia, Salivary Hypersecretion, Blood Creatine Phosphokinase Increased, Urinary Retention (8473307-9)
on Jun 18, 2012 Male patient from JAPAN , 67 years of age, weighting 112.4 lb, was treated with Zolpidem(View Usage). After Zolpidem was administered, patient had the following side effects: rhabdomyolysis, renal failure acute, bradykinesia, salivary hypersecretion, blood creatine phosphokinase increased, urinary retention. Zolpidem dosage: Tabs.
Patient was taking other medications: Patient was hospitalized and became disabled.

Suicide Attempt, Anxiety, Depressed Mood (8473139-1)
Patient was taking Zolpidem (View Usage). Patient experienced the following unwanted or unexpected effects: suicide attempt, anxiety (anxiety Questions), depressed mood on Jun 22, 2012 from JAPAN Additional patient health information: Male patient , 55 years of age, . Zolpidem dosage: Unk.
Patient was taking other medications:

Cardiac Arrest (8471403-3)
Adverse event was reported on Jun 26, 2012 by a Male patient taking Zolpidem (View Usage) (Dosage: N/A) . Location: UNITED STATES , 67 years of age, weighting 110.0 lb, Patient had the following side effects: cardiac arrest (cardiac arrest Questions).
Patient was taking other medications: Patient was hospitalized.

Hallucination, Feeling Abnormal, Activities Of Daily Living Impaired, Cognitive Disorder (8469430-5)
on Jun 21, 2012 Female patient from UNITED STATES , 76 years of age, weighting 170.0 lb, was diagnosed with and was treated with Zolpidem (View Usage). After Zolpidem was administered, patient had the following side effects: hallucination, feeling abnormal, activities of daily living impaired, cognitive disorder. Zolpidem dosage: 5 Mg Once.

Panic Attack, Presyncope (8467046-8)
on Jun 11, 2012 Male patient from GERMANY , 44 years of age, weighting 160.9 lb, was diagnosed with and was treated with Zolpidem Tartrate(View Usage). Patient experienced the following unwanted or unexpected effects: panic attack, presyncope. Zolpidem Tartrate dosage: 10mg Milligram(s).

Palpitations, Anxiety, Off Label Use, Insomnia, Irritability, Withdrawal Syndrome, Tremor (8465568-7)
Patient was taking Zolpidem (View Usage). Patient had the following side effects: palpitations, anxiety (anxiety Questions), off label use, insomnia, irritability, withdrawal syndrome, tremor on Jun 12, 2012 from TAIWAN, PROVINCE OF CHINA Additional patient health information: Female patient , 53 years of age, was diagnosed with
  • insomnia
and. Zolpidem dosage: (10 Mg,at Bedtime) ; (30 Mg,daily In Divided Doses) ; 100 To 160 Mg (daily. Patient was hospitalized.

Blood Creatine Phosphokinase Increased (8463101-7)
Adverse event was reported on Jun 14, 2012 by a Female patient taking Zolpidem (View Usage) (Dosage: N/A) . Location: JAPAN , 85 years of age, After Zolpidem was administered, patient had the following side effects: blood creatine phosphokinase increased.

Product Substitution Issue (8462360-4)
on Jun 19, 2012 Female patient from UNITED STATES , weighting 174.2 lb, was diagnosed with
  • insomnia
and was treated with Zolpidem (View Usage). Patient experienced the following unwanted or unexpected effects: product substitution issue. Zolpidem dosage: 10 Mg Take 1/2 Tab Qhs Po.

Myopathy Toxic (8460396-0)
on Jun 13, 2012 Female patient from GERMANY , 54 years of age, was treated with Zolpidem(View Usage). Patient had the following side effects: myopathy toxic. Zolpidem dosage: N/A.
Patient was taking other medications: Patient was hospitalized.

Convulsion, Rash, Diarrhoea (8459704-6)
Patient was taking Zolpidem (View Usage). After Zolpidem was administered, patient had the following side effects: convulsion, rash (rash Questions), diarrhoea on Jun 15, 2012 from JAPAN Additional patient health information: Male patient , 82 years of age, was diagnosed with
  • insomnia
  • hypertension
and. Zolpidem dosage: N/A.
Patient was taking other medications: Patient was hospitalized.

Thrombosis, Emotional Distress, Cerebrovascular Accident, Pain, Injury (8458660-4)
Adverse event was reported on Jun 14, 2012 by a Female patient taking Zolpidem (View Usage) (Dosage: N/A) . Location: UNITED STATES , 46 years of age, Patient experienced the following unwanted or unexpected effects: thrombosis, emotional distress, cerebrovascular accident, pain (pain Questions), injury.
Patient was taking other medications:

Pollakiuria, Urine Odour Abnormal, Renal Impairment, Dysuria, Decreased Appetite, Urinary Retention (8458498-8)
on Jun 11, 2012 Female patient from JAPAN , 85 years of age, was treated with Zolpidem (View Usage). Patient had the following side effects: pollakiuria, urine odour abnormal, renal impairment, dysuria, decreased appetite, urinary retention. Zolpidem dosage: N/A.
Patient was taking other medications:

Product Quality Issue, Product Contamination, Hallucination, Refusal Of Treatment By Patient, Nightmare (8457716-X)
on Jun 18, 2012 Female patient from UNITED STATES , 54 years of age, weighting 112.0 lb, was diagnosed with
  • initial insomnia
and was treated with Zolpidem(View Usage). After Zolpidem was administered, patient had the following side effects: product quality issue, product contamination, hallucination, refusal of treatment by patient, nightmare. Zolpidem dosage: 10mg Nightly Po. Patient was hospitalized and became disabled.

Ill-defined Disorder, Back Pain, Vomiting, Chronic Obstructive Pulmonary Disease, Depression, Productive Cough, Oropharyngeal Pain, Treatment Noncompliance, Emotional Distress (8456847-8)
Patient was taking Zolpidem (View Usage). Patient experienced the following unwanted or unexpected effects: ill-defined disorder, back pain (back pain Questions), vomiting, chronic obstructive pulmonary disease, depression (depression Questions), productive cough, oropharyngeal pain, treatment noncompliance, emotional distress on Jun 12, 2012 from UNITED STATES Additional patient health information: Female patient , 77 years of age, weighting 130.0 lb, . Zolpidem dosage: N/A.
Patient was taking other medications: Patient was hospitalized.

Neutrophilia, Respiratory Failure (8456703-5)
Adverse event was reported on Jun 13, 2012 by a Female patient taking Zolpidem (View Usage) (Dosage: N/A) was diagnosed with
  • prophylaxis
and. Location: JAPAN , weighting 138.9 lb, Patient had the following side effects: neutrophilia, respiratory failure.
Patient was taking other medications:

Pyrexia, Bradykinesia, Urinary Retention, Dysphagia, Renal Failure Acute, Altered State Of Consciousness, Rhabdomyolysis (8455504-1)
on Jun 20, 2012 Male patient from JAPAN , weighting 112.4 lb, was diagnosed with and was treated with Zolpidem Tartrate (View Usage). After Zolpidem was administered, patient had the following side effects: pyrexia, bradykinesia, urinary retention, dysphagia, renal failure acute, altered state of consciousness, rhabdomyolysis. Zolpidem Tartrate dosage: N/A.
Patient was taking other medications: Patient was hospitalized.

Anger, Fall, Hallucination, Confusional State, Agitation, Transient Ischaemic Attack, Coordination Abnormal, Atrial Fibrillation, Dysarthria (8454258-2)
on Jun 12, 2012 Female patient from NETHERLANDS , weighting 134.5 lb, was treated with Zolpidem Tartrate(View Usage). Patient experienced the following unwanted or unexpected effects: anger, fall (fall Questions), hallucination, confusional state, agitation, transient ischaemic attack, coordination abnormal, atrial fibrillation (atrial fibrillation Questions), dysarthria. Zolpidem Tartrate dosage: 10 Mg, Qd.
Patient was taking other medications:

Showing 1-25 of 1999 


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Zolpidem Adverse Effect Reports (FDA)

Enter Unusual Symptoms or Side Effects:

Zolpidem Information

Alternative ZOLPIDEM Names:AMBIEN AMBIEN CR EDLUAR INTERMEZZO ZOLPIMIST

Substance: ZOLPIDEM

More About Zolpidem

Side Effects reported to FDA: 1999. View FDA Adverse Reports

Zolpidem safety alerts: 2013 2007

Reported deaths: 234

Reported hospitalizations: 345

1Literally Dozens - Now 2 Years Off Zolpidem I Suff
2Elevated Sex Drive
3Myocardial Infarction
4Pyelonephritis
5Literally Dozens - Now 2 Years Off Zolpidem I Suffer Prolonged/protracted Withdrawal Syndrome (vestibular Function Damaged, Tinnitus, Brain Damage Etc.
6UTI
7Rash
8Polyneuropathy
9Back Pain
10Vasculitis
View More

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allergic reaction, itching- armpits, hands, feet, groin

It definately helps you sleep, but you

Mood change, Agitation, Anxiety, agrression- I got

I was told by my daughter today

tired,gain weight but did not eat anymore,felt

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Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses

Including Ambien, Ambien CR, Edluar, and Zolpimist 

 

[Posted 01/10/2013]

AUDIENCE: Family Practice, Health Professional, Patient

ISSUE: FDA is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. This announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.

FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.

For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men.

Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose.

FDA is continuing to evaluate the risk of impaired mental alertness with other insomnia drugs, including over-the-counter (OTC) drugs available without a prescription.

FDA prepared a list of questions and answers to provide an additional overview of this safety issue. See the FDA Drug Safety Communication for a Data Summary.

BACKGROUND: Zolpidem is a sedative-hypnotic (sleep) medicine used in adults for the treatment of insomnia. It is marketed as generics and under the brand-names Ambien, Ambien CR, Edluar, Zolpimist, and Intermezzo.

RECOMMENDATION: FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.

  • The recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).
  • For zolpidem and other insomnia drugs, prescribe the lowest dose that treats the patient’s symptoms.
  • Inform patients that impairment from sleep drugs can be present despite feeling fully awake.
  • The recommended doses of Intermezzo, a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing. At the time of Intermezzo’s approval in November 2011, the label already recommended a lower dosage for women than for men.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[01/10/2013 - Drug Safety Communication - FDA]
[01/10/2013 - Questions and Answers - FDA]
[01/10/2013 - Consumer Update - FDA]
[01/10/2013 - News Release - FDA]

further research and contacting my doctor

When did you start feeling unusual symptoms? what was the first symptom? Did your symptoms get worse over time? Did you have similar symptoms before using Zolpidem? What did Your doctor say? Share Your Story

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Zolpidem Adverse Reactions
Amnesia ( 205 Reports)
Somnambulism ( 174 Reports)
Completed Suicide ( 167 Reports)
Insomnia ( 161 Reports)
Product Substitution Issue ( 138 Reports)
Delirium ( 102 Reports)
Confusional State ( 96 Reports)
Cardiac Arrest ( 78 Reports) Cardiac arrest Questions
Fall ( 76 Reports) Fall Questions
Road Traffic Accident ( 76 Reports)
Dizziness ( 74 Reports) Dizziness Questions
Somnolence ( 72 Reports)
Loss Of Consciousness ( 70 Reports)
Anxiety ( 68 Reports) Anxiety Questions
Respiratory Arrest ( 68 Reports)
Abnormal Behaviour ( 65 Reports)
Headache ( 64 Reports) Headache Questions
Hallucination ( 62 Reports)
Agitation ( 59 Reports)
Poisoning ( 55 Reports) Poisoning Questions
Toxicity To Various Agents ( 55 Reports)
Nausea ( 53 Reports) Nausea Questions
Cardio-respiratory Arrest ( 52 Reports)
Abnormal Sleep-related Event ( 50 Reports)
Disorientation ( 49 Reports)
Overdose ( 46 Reports)
Feeling Abnormal ( 45 Reports)
Depression ( 43 Reports) Depression Questions
Intentional Overdose ( 43 Reports)
Product Quality Issue ( 43 Reports)

side effects
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