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. 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:.
Rare: gout, hypercholesteremia, hyperlipidemia, increased alkaline phosphatase, increased BUN, periorbital edema. Infrequent: hyperglycemia, thirst. Musculoskeletal system:.
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.
Body as a whole:
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.
In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness. Ambien should be taken as a single dose and should not be readministered during the same night. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediay before bedtime with at least 7–8 hours remaining before the planned time of awakening. Use the lowest effective dose for the patient. If the 5 mg dose is not effective, the dose can be increased to 10 mg. The total dose of AMBIEN should not exceed 10 mg once daily immediay before bedtime.
NDC Number Size bottle of 100 bottle of 500.
Frequent: diplopia, vision abnormal. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia. Infrequent: eye irritation, eye pain, scleritis, taste perversion, tinnitus. Urogenital system:.
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. AMBIEN was administered to,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.
LLC, Bridgewater, NJ 08807. Distributed by: sanofi-aventis U.S. Revised: Dec 2016.
Avoid AMBIEN use in patients with severe hepatic impairment as it may contribute to encephalopathy [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, CLINICAL PHARMACOLOGY ]. The recommended dose of AMBIEN in these patients is 5 mg once daily immediay before bedtime. Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects.
Liver and biliary system:
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. It is important to emphasize that, although the events reported did occur during treatment with AMBIEN, they were not necessarily caused by it. 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.
Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem. Use of CYP3A4 inducers in combination with zolpidem may decrease the efficacy of zolpidem.
Reactions most commonly associated with discontinuation from U.S. 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. Approximay 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S. 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%). premarketing clinical trials discontinued treatment because of an adverse reaction. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).
Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. Abuse and addiction are separate and distinct from physical dependence and tolerance. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving.
Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic.
Infrequent: pruritus. Rare: acne, bullous eruption, dermatitis, furunculosis, injection-site inflammation, photosensitivity reaction, urticaria. Special senses:.
AMBIEN is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.
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. 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. 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. Events reported by investigators were classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies.
Infrequent: cystitis, urinary incontinence. Frequent: urinary tract infection. Rare: acute renal failure, dysuria, micturition frequency, nocturia, polyuria, pyelonephritis, renal pain, urinary retention.
40, iron oxide colorant, and polysorbate 80. The 5 mg tablet also contains FD&C Red No. Each AMBIEN tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, micro- crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.
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:.
Hematologic and lymphatic system:
An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated.
Concomitant administration of zolpidem and sertraline increases exposure to zolpidem.
Metabolic and nutritional:. Rare: bilirubinemia, increased SGOT. Infrequent: abnormal hepatic function, increased SGPT.
Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease. Cardiovascular system:. Infrequent: edema, falling, fatigue, fever, malaise, trauma. Frequent: asthenia.
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.
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.
Frequent: dyspepsia, hiccup, nausea. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries. Infrequent: anorexia, constipation, dysphagia, flatulence, gastroenteritis, vomiting.
It has the following structure:. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo pyridine-3-acetamide L-(+)-tartrate (2:1).
AMBIEN 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other.
AMBIEN 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other and supplied as:
AMBIEN (zolpidem tartrate) Tablets.
Post-marketing reports of abuse, dependence and withdrawal have been received. These reported adverse events occurred at an incidence of 1% or less. Sedative /hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. clinical trials following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and abdominal discomfort. The following adverse events which are considered to meet the DSM -III-R criteria for uncomplicated sedative/ hypnotic withdrawal were reported during U.S.
Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo.
It has a molecular weight of 764.88. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol.
Central and peripheral nervous system:
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%).
The recommended initial doses for women and men are different because zolpidem clearance is lower in women.
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of AMBIEN in these patients is 5 mg once daily immediay before bedtime [see WARNINGS AND PRECAUTIONS, Use In Specific Populations ].
The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration. A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem.
Rare: abnormal accommodation, altered saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus. Infrequent: increased sweating, pallor, postural hypotenson, syncope.
Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, breast pain. Respiratory system:.
Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media. Infrequent: infection.
The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
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. The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients. The following table was derived from results of three placebo-controlled long-term efficacy trials involving AMBIEN (zolpidem tartrate). The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.
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).
Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability. Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.
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. The following adverse reactions have been identified during post-approval use of AMBIEN.
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AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Some compounds known to induce or inhibit CYP3A may affect exposure to zolpidem. The effect of drugs that induce or inhibit other P450 enzymes on the exposure to zolpidem is not known.
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.
The effect of AMBIEN may be slowed by ingestion with or immediay after a meal.
Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance.
Consideration should be given to using a lower dose of zolpidem when a potent CYP3A4 inhibitor and zolpidem are given together. Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic effects of zolpidem.
Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Immunologic system:. Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.
Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
Rare: bronchospasm, respiratory depression, epistaxis, hypoxia, laryngitis, pneumonia. Infrequent: bronchitis, coughing, dyspnea, rhinitis. Frequent: upper respiratory infection, lower respiratory infection. Skin and appendages:.
Rare: arthrosis, muscle weakness, sciatica, tendinitis. Infrequent: arthritis. Frequent: arthralgia, myalgia. Reproductive system:.
AMBIEN (zolpidem tartrate) is a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.
AMBIEN 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other.
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. Zolpidem may cause a severe allergic reaction.
Store at controlled room temperature 20°–25°C (68°–77°F).
Dosage adjustment may be necessary when AMBIEN is combined with other CNS depressant drugs because of the potentially additive effects.
There was no evidence of an additive effect in psychomotor performance. After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed.
AMBIEN 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other and supplied as:
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.
NDC Number Size bottle of 100.
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.Zolpidem