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Ambien CR

"Sleep disorder drugs (hypnotic and sedative drugs) overview

Insomnia, a disorder in which there is difficulty sleeping, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself "...

Ambien CR

Ambien CR

Ambien CR Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Ambien CR (zolpidem tartrate) is a sedative-hypnotic drug used to treat patients with insomnia and other problems with sleeping like maintaining sleep. The CR means extended release. Ambien CR is available as a generic termed zolpidem tartrate. Some common side effects of Ambien CR are drowsiness, headache, dizziness, depression, unusual thinking, including thoughts of self-injury, anxiety, aggression, and risk-taking

Ambien CR is available in 6.25 or 12.5 mg tablets. The usual dose is 12.5 mg per day; some patients (elderly) may need only 6.25 mg per day. The tablets should not be chewed or crushed to avoid a more rapid drug adsorption. Ambien CR should be taken only before bedtime when the individual should expect to stay in bed all night (about 7 - 8 hours). Individuals should not attempt driving or doing any work that is hazardous after taking the evening dose. Most sleep problems should resolve after 2 weeks. Ambien CR is recommended to not exceed 2 weeks of usage. More frequent and severe occurrences of those side effects listed above require medical reevaluation of the drugs dose or use. Other infrequent but severe side effects include allergic reactions, chest pain, arrhythmias, dementia, thrombosis, and dermatitis. Unusual and dangerous "sleep driving" has occurred with a few patients. Abuse and dependence on Ambien has been reported. Abrupt stoppage of the drug after long-term use result in withdrawal in some patients. The prescribing doctor should be immediately contacted if the side effects occur. Ambien CR should not be taken with alcohol and used carefully if the patient has other anti-depressant medications or sleep-related problems like sleep apnea or COPD. Safety and effectiveness is not established in pediatric patients. Use in pregnant and nursing women is cautioned; risks versus benefits should be carefully judged, some studies suggest the fetus is affected while others suggest the drug is found in breast milk.

Our Ambien CR Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ambien CR in Detail - Patient Information: Side Effects

Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using zolpidem and call your doctor at once if you have a serious side effects:

  • chest pain, fast or irregular heartbeat, feeling short of breath;
  • trouble breathing or swallowing; or
  • feeling like you might pass out.

Less serious side effects may include:

  • daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;
  • tired feeling, loss of coordination;
  • dry mouth, nose or throat irritation;
  • nausea, constipation, diarrhea, upset stomach;
  • stuffy nose, sore throat; or
  • headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ambien CR (Zolpidem Tartrate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ambien CR Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ambien CR (Zolpidem Tartrate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ambien CR FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Serious anaphylactic and anaphylactoid reactions [seeWARNINGS AND PRECAUTIONS)
  • Abnormal thinking, behavior changes, and complex behaviors [seeWARNINGS AND PRECAUTIONS]
  • Withdrawal effects [seeWARNINGS AND PRECAUTIONS]
  • CNS-depressant effects [seeWARNINGS AND PRECAUTIONS]

Clinical trials experience

Associated with discontinuation of treatment: In 3-week clinical trials in adults and elderly patients ( > 65 years), 3.5% (7/201) patients receiving Ambien CR (zolpidem tartrate) 6.25 or 12.5 mg discontinued treatment due to an adverse reaction as compared to 0.9% (2/216) of patients on placebo. The reaction most commonly associated with discontinuation in patients treated with Ambien CR (zolpidem tartrate) was somnolence (1%).

In a 6-month study in adult patients (18-64 years of age), 8.5% (57/669) of patients receiving Ambien CR (zolpidem tartrate) 12.5 mg as compared to 4.6% on placebo (16/349) discontinued treatment due to an adverse reaction. Reactions most commonly associated with discontinuation of Ambien CR (zolpidem tartrate) included anxiety (anxiety, restlessness or agitation) reported in 1.5% (10/669) of patients as compared to 0.3% (1/349) of patients on placebo, and depression (depression, major depression or depressed mood) reported in 1.5% (10/669) of patients as compared to 0.3% (1/349) of patients on placebo.

Data from a clinical study in which selective serotonin reuptake inhibitor- (SSRI-) treated patients were given zolpidem revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n =97) was discontinued after an attempted suicide.

Most commonly observed adverse reactions in controlled trials: During treatment with Ambien CR (zolpidem tartrate) in adults and elderly at daily doses of 12.5 mg and 6.25 mg, respectively, each for three weeks, the most commonly observed adverse reactions associated with the use of Ambien CR (zolpidem tartrate) were headache, next-day somnolence, and dizziness.

In the 6-month trial evaluating Ambien CR (zolpidem tartrate) 12.5 mg, the adverse reaction profile was consistent with that reported in short-term trials, except for a higher incidence of anxiety (6.3% for Ambien CR (zolpidem tartrate) versus 2.6% for placebo).

Adverse reactions observed at an incidence of ≥ 1% in controlled trials: The following tables enumerate treatment-emergent adverse reaction frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received Ambien CR (zolpidem tartrate) in placebo-controlled trials. Events reported by investigators were classified utilizing the MedDRA dictionary for the purpose of establishing event frequencies. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of conditions. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

The following tables were derived from results of two placebo-controlled efficacy trials involving Ambien CR (zolpidem tartrate) . These trials involved patients with primary insomnia who were treated for 3 weeks with Ambien CR (zolpidem tartrate) at doses of 12.5 mg (Table 1) or 6.25 mg (Table 2), respectively. The tables include only adverse reactions occurring at an incidence of at least 1% for Ambien CR (zolpidem tartrate) patients and with an incidence greater than that seen in the placebo patients.

Table 1. Incidences of Treatment-Emergent Adverse Reactions in a 3-Week Placebo-Controlled Clinical Trial in Adults (percentage of patients reporting)

Body System/Adverse Reaction* Ambien CR (zolpidem tartrate)
12.5 mg
(N = 102)
Placebo
(N = 110)
Infections and infestations
  Influenza 3 0
  Gastroenteritis 1 0
  Labyrinthitis 1 0
Metabolism and nutrition disorders
  Appetite disorder 1 0
Psychiatric disorders
  Hallucinations** 4 0
  Disorientation 3 2
  Anxiety 2 0
  Depression 2 0
  Psychomotor retardation 2 0
  Binge eating 1 0
  Depersonalization 1 0
  Disinhibition 1 0
  Euphoric mood 1 0
  Mood swings 1 0
  Stress symptoms 1 0
Nervous system disorders
  Headache 19 16
  Somnolence 15 2
  Dizziness 12 5
  Memory disorders*** 3 0
  Balance disorder 2 0
  Disturbance in attention 2 0
  Hypoesthesia 2 1
  Ataxia 1 0
  Paresthesia 1 0
Eye disorders
  Visual disturbance 3 0
  Eye redness 2 0
  Vision blurred 2 1
  Altered visual depth perception 1 0
  Asthenopia 1 0
Ear and labyrinth disorders
  Vertigo 2 0
  Tinnitus 1 0
Respiratory, thoracic and mediastinal disorders
  Throat irritation 1 0
Gastrointestinal disorders
  Nausea 7 4
  Constipation 2 0
  Abdominal discomfort 1 0
  Abdominal tenderness 1 0
  Frequent bowel movements 1 0
  Gastroesophageal reflux disease 1 0
  Vomiting 1 0
Skin and subcutaneoustissuedisorders
  Rash 1 0
  Skin wrinkling 1 0
  Urticaria 1 0
Musculoskeletal and connective tissue disorders
  Back pain 4 3
  Myalgia 4 0
  Neck pain 1 0
Reproductive system and breast disorders
  Menorrhagia 1 0
General disorders and administration site conditions
  Fatigue 3 2
  Asthenia 1 0
  Chest discomfort 1 0
Investigations
  Blood pressure increased 1 0
  Body temperature increased 1 0
Injury, poisoning and procedural complications
  Contusion 1 0
Social circumstances
  Exposure to poisonous plant 1 0
*Reactions reported by at least 1% of patients treated with Ambien CR (zolpidem tartrate) and at greater frequency than in the placebo group.
**Hallucinations included hallucinations NOS as well as visual and hypnogogic hallucinations.
***Memory disorders include: memory impairment, amnesia, anterograde amnesia.

Table 2. Incidences of Treatment-Emergent Adverse Reactions in a 3-Week Placebo-Controlled Clinical Trial in Elderly (percentage of patients reporting)

Body System/Adverse Reaction* Ambien CR (zolpidem tartrate)
6.25 mg
(N=99)
Placebo
(N=106)
Infections and infestations
  Nasopharyngitis 6 4
  Lower respiratory tract infection 1 0
  Otitis externa 1 0
  Upper respiratory tract infection 1 0
Psychiatric disorders
  Anxiety 3 2
  Psychomotor retardation 2 0
  Apathy 1 0
  Depressed mood 1 0
Nervous system disorders
  Headache 14 11
  Dizziness 8 3
  Somnolence 6 5
  Burning sensation 1 0
  Dizziness postural 1 0
  Memory disorders** 1 0
  Muscle contractions involuntary 1 0
  Paresthesia 1 0
  Tremor 1 0
Cardiac disorders
  Palpitations 2 0
Respiratory, thoracic and mediastinal disorders
  Dry throat 1 0
Gastrointestinal disorders
  Flatulence 1 0
  Vomiting 1 0
Skin and subcutaneoustissuedisorders
  Rash 1 0
  Urticaria 1 0
Musculoskeletal and connective tissue disorders
  Arthralgia 2 0
  Muscle cramp 2 1
  Neck pain 2 0
Renal and urinary disorders
  Dysuria 1 0
Reproductive system andbreastdisorders
  Vulvovaginal dryness 1 0
General disorders and administration site conditions
  Influenza like illness 1 0
  Pyrexia 1 0
Injury, poisoning and procedural complications
  Neck injury 1 0
*Reactions reported by at least 1% of patients treated with Ambien CR and at greater frequency than in the placebo group. **Memory disorders include: memory impairment, amnesia, anterograde amnesia.

Dose relationship for adverse reactions: There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem use, particularly for certain CNS and gastrointestinal adverse events.

Other adverse reactions observed during the premarketing evaluation of Ambien CR (zolpidem tartrate) : Other treatment-emergent adverse reactions associated with participation in Ambien CR (zolpidem tartrate) studies (those reported at frequencies of < 1%) were not different in nature or frequency to those seen in studies with immediate-release zolpidem tartrate, which are listed below.

Adverse Events Observed During the Premarketing Evaluation of Immediate-Release Zolpidem Tartrate: Immediate-release zolpidem tartrate was administered to 3,660 subjects in clinical trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.

The frequencies presented, therefore, represent the proportions of the 3,660 individuals exposed to zolpidem, at all doses, who experienced an event of the type cited on at least one occasion while receiving zolpidem. All reported treatment-emergent adverse events are included, except those already listed in the table above of adverse events in placebo-controlled studies, those coding terms that are so general as to be uninformative, and those events where a drug cause was remote. It is important to emphasize that, although the events reported did occur during treatment with Ambien, they were not necessarily caused by it.

Adverse events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in greater than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in less than 1/1,000 patients.

Autonomic nervous system: Frequent: dry mouth. Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.

Body as a whole: Frequent: asthenia. Infrequent: chest pain, edema, falling, fever, malaise, trauma. Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease.

Cardiovascular system: Infrequent: cerebrovascular disorder, hypertension, tachycardia. Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia.

Central and peripheral nervous system: Frequent: ataxia, confusion, drowsiness, drugged feeling, euphoria, insomnia, lethargy, lightheadedness, vertigo. Infrequent: agitation, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libido, delusion, dementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathy, neurosis, panic attacks, paresis, personality disorder, somnambulism, suicide attempts, tetany, yawning.

Gastrointestinal system: Frequent: diarrhea, dyspepsia, hiccup. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.

Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.

Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.

Liver and biliary system: Infrequent: abnormal hepatic function, increased SGPT. Rare: bilirubinemia, increased SGOT.

Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.

Musculoskeletal system: Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendinitis.

Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain.

Respiratory system: Frequent: sinusitis. Infrequent: bronchitis, coughing, dyspnea. Rare: bronchospasm, epistaxis, hypoxia, laryngitis, pneumonia.

Skin and appendages: Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria.

Special senses: Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.

Urogenital system: Frequent: urinary tract infection. Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention.

Read the entire FDA prescribing information for Ambien CR (Zolpidem Tartrate) »

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Ambien CR - User Reviews

Ambien CR User Reviews

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Here is a collection of user reviews for the medication Ambien CR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

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