The following adverse reactions have been identified during post-approval use of AMBIEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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.
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.
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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.
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Rare: arthrosis, muscle weakness, sciatica, tendinitis. Infrequent: arthritis. Reproductive system:. Frequent: arthralgia, myalgia.
Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Infrequent: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.
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: ataxia, confusion, euphoria, headache, insomnia, vertigo Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional lability, hallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor.
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Body as a whole:
Rare: angina pectoris, arrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarction, phlebitis, pulmonary embolism, pulmonary edema, varicose veins, ventricular tachycardia. Infrequent: cerebrovascular disorder, hypertension, tachycardia.
Respiratory system:. Rare: breast fibroadenosis, breast neoplasm, breast pain. Infrequent: menstrual disorder, vaginitis.
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Liver and biliary system: acute hepatocellular, cholestatic or mixed liver injury with or without jaundice (i.e., bilirubin >2×ULN, alkaline phosphatase ≥2×ULN, transaminase ≥5×ULN).
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Infrequent: abnormal hepatic function, increased SGPT. Metabolic and nutritional:. Rare: bilirubinemia, increased SGOT.
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The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The following table was derived from results of three placebo-controlled long-term efficacy trials involving AMBIEN (zolpidem tartrate). These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg.
Urogenital system:. Frequent: diplopia, vision abnormal. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.
Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials Lasting up to 35 Nights (Percentage of patients reporting) Body System/ Adverse Event* Zolpidem (≤10 mg) (N=152) Placebo (N=161) Autonomic Nervous System Dry mouth 3 1 Body as a Whole Allergy 4 1 Back Pain 3 2 Influenza-like symptoms 2 - Chest pain 1 - Cardiovascular System Palpitation 2 - Central and Peripheral Nervous System Drowsiness 8 5 Dizziness 5 1 Lethargy 3 1 Drugged feeling 3 - Lightheadedness 2 1 Depression 2 1 Abnormal dreams 1 - Amnesia 1 - Sleep disorder 1 - Gastrointestinal System Diarrhea 3 2 Abdominal pain 2 2 Constipation 2 1 Respiratory System Sinusitis 4 2 Pharyngitis 3 1 Skin and Appendages Rash 2 1 *Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.
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Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus. Infrequent: increased sweating, pallor, postural hypotenson, syncope.
Infrequent: edema, falling, fatigue, 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:. Frequent: asthenia.
AMBIEN was administered to,660 subjects in clinical trials throughout the U.S., Canada, and Europe. 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. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing.
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Hematologic and lymphatic system:
Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur. You may report side effects to FDA at 1-800-FDA-1088.
During longer-term treatment (28 to 35 nights) with zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%). During short-term treatment (up to 10 nights) with AMBIEN at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%).
l your doctor all medications and supplements you use. Ambien passes into breast milk and may have adverse effects on a nursing baby. The recommended adult dose of Ambien is 10 mg as conventional tablets or spray or 12.5 mg as extended-release tablets. Ambien may interact with alcohol, other medicines that make you sleepy or slow your breathing (such as cold medicines, pain medications, muscle relaxants, and medicines for depression, anxiety, or seizures), chlorpromazine, itraconazole, ketoconazole, rifampin, or antidepressants. Ambien can cause withdrawal symptoms (muscle cramps, sweats, shaking, and seizures). Consult your doctor before breastfeeding. l your doctor if you are pregnant or plan to become pregnant before using Ambien; it is unknown how it will affect a fetus.
Heart Failure. Cardiac Arrest vs. Heart Disease Heart Attack vs.
Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. 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. The following tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.S. 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. placebo-controlled trials. 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.
Special senses:. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria. Infrequent: pruritus.
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You may report side effects to FDA at 1-800-FDA-1088. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
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Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries. Frequent: dyspepsia, hiccup, nausea.
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efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The following table was derived from results of 11 placebo-controlled short-term U.S. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.
Read the entire detailed patient monograph for Ambien (Zolpidem Tartrate).
Read the entire FDA prescribing information for Ambien (Zolpidem Tartrate).
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Incidence of Treatment-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials Lasting up to 10 Nights (Percentage of patients reporting) Body System/ Adverse Event* Zolpidem (≤10 mg) (N=685) Placebo (N=473) Central and Peripheral Nervous System Headache 7 6 Drowsiness 2 - Dizziness 1 - Gastrointestinal System Diarrhea 1 - *Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.
Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis. Immunologic system:.
Infrequent: cystitis, urinary incontinence. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention. Frequent: urinary tract infection.
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Central and peripheral nervous system:
Skin and appendages:. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Frequent: upper respiratory infection, lower respiratory infection. Rare: bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia.
Infrequent: hyperglycemia, thirst. Musculoskeletal system:. Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema.
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Common side effects may include:
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Stop using zolpidem and call your doctor at once if you have:
Medical Editor: John P. Cunha, DO, FACOEP.
Last reviewed on RxList 03/17/2017.
Our Ambien (zolpidem) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
It is important to emphasize that, although the events reported did occur during treatment with AMBIEN, they were not necessarily caused by it. 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.
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:.
Liver and biliary system:
Approximay 4% of 1,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/ vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%). Approximay 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%). Reactions most commonly associated with discontinuation from U.S.
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Ambien is available in generic form. Common side effects of Ambien (zolpidem) include:. Ambien (zolpidem) is a sedative /hypnotic used for treating insomnia.Ambien