Cosette Pharmaceuticals, Inc.
Ambien cr
BrandGeneric: Zolpidem tartrate
ID: 00713550101
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TL;DR — Quick Summary
Key facts from the full medication guide below
🩺What it's for
AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient reported assessment in adult patients only) in duration [see Clinical Studies (14)].
💊How to take it
Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily ( 2.1) Treatment should be as short as possible ( 2.1) Recommended initial dose is a single dose of 6.25 mg for women and a single dose of 6.25 or 12.5 mg for men, immediately before bedtime with at least 7 8 hours remaining before the planned time of awakening ( 2.1) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women ( 2.2) Lower doses…
ℹ️Common side effects
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions (5.1)] CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2)] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions (5.4)] Abnormal Thinking and Behavior Changes [see Warnings and Precautions (5.5)] Withdrawal Effects [see Warnings and Precautions (5.9)] Most commonly observed adverse…
⚠️Serious risks
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN CR. Some of these events may result in serious injuries, including death. Discontinue AMBIEN CR immediately if a patient experiences a complex sleep behavior [see Contraindications (4)and Warnings and Precautions (5.1)]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning.
📋Interactions & cautions
CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects ( 5.2, 7.1) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7, 7.1) Imipramine: Decreased alertness observed ( 7.1) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1) CYP3A4 inducers (rifampin or St.
📦Storage & missed dose
AMBIEN CR 6.25 mg extended-release tablets are composed of two layers* and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as: NDC Number Size 0713-5501-01 bottle of 100 AMBIEN CR 12.5 mg extended-release tablets are composed of two layers* and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as: NDC Number Size 0713-5521-01 bottle of 100 *Layers are covered by the coating and are indistinguishable.
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Zolpidem tartrate (Ambien cr) Prices
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Indications and Usage ( 1) 2/2022 Dosage and Administration ( 2.1) 2/2022 Warnings and Precautions ( 5.5) 2/2022 Warnings and Precautions ( 5.7) 2/2022
AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient reported assessment in adult patients only) in duration [see Clinical Studies (14)]. AMBIEN CR, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1)
Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily ( 2.1) Treatment should be as short as possible ( 2.1) Recommended initial dose is a single dose of 6.25 mg for women and a single dose of 6.25 or 12.5 mg for men, immediately before bedtime with at least 7 8 hours remaining before the planned time of awakening ( 2.1) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women ( 2.2) Lower doses of CNS depressants may be necessary when taken concomitantly with AMBIEN CR ( 2.3) Tablets to be swallowed whole, not to be crushed, divided or chewed ( 2.4) The effect of AMBIEN CR may be slowed if taken with or immediately after a meal ( 2.4)
Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7 8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next-day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.2)] . The total dose of AMBIEN CR should not exceed 12.5 mg once daily immediately before bedtime. AMBIEN CR should be taken as a single dose and should not be readministered during the same night. The recommended initial doses for women and men are different because zolpidem clearance is lower in women. Treatment with AMBIEN CR should be as short as possible. Extended treatment should not take place without re-evaluation of the patient s status, since the risk of abuse and dependence increases with duration of treatment [see Drug Abuse and Dependence (9.3)].
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of AMBIEN CR in these patients is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.2), Use in Specific Populations (8.5)]. Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of AMBIEN CR in these patients is 6.25 mg once daily immediately before bedtime. Avoid AMBIEN CR use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions (5.8), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)] .
Dosage adjustment may be necessary when AMBIEN CR is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.2, 5.7)] .
AMBIEN CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of AMBIEN CR may be slowed by ingestion with or immediately after a meal.
AMBIEN CR is available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored. AMBIEN CR 6.25 mg tablets are pink, round, bi-convex, and debossed with A~ on one side. AMBIEN CR 12.5 mg tablets are blue, round, bi-convex, and debossed with A~ on one side. Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets notscored. ( 3)
AMBIEN CR is contraindicated in patients who have experienced complex sleep behaviors after taking AMBIEN CR [see Warnings and Precautions (5.1)]. with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. Patients who have experienced complex sleep behaviors after taking AMBIEN CR ( 4) Known hypersensitivity to zolpidem ( 4)
CNS-Depressant Effects: Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring complete mental alertness the morning after use. Instruct patients on correct use. ( 5.2) Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. ( 5.3) Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. ( 5.4) Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes. ( 5.5) Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to avoid intentional overdose. ( 5.6) Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function. ( 5.7) Hepatic Impairment: Avoid AMBIEN CR use in patients with severe hepatic impairment. ( 5.8) Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation. ( 5.9, 9.3)
Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of AMBIEN CR. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Postmarketing reports have shown that complex sleep behaviors may occur with AMBIEN CR alone at recommended doses, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interactions (7.1)] . Discontinue AMBIEN CR immediately if a patient experiences a complex sleep behavior [see Contraindications (4)] .
AMBIEN CR is a CNS depressant and can impair daytime function in some patients even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of subjective symptoms, and may not be reliably detected by ordinary clinical exam (i.e. less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of AMBIEN CR may develop, patients using AMBIEN CR should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use. Additive effects occur with concomitant use of other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use [see Drug Interactions (7.1)] . Downward dose adjustment of AMBIEN CR and concomitant CNS depressants should be considered [see Dosage and Administration (2.3)] . The use of AMBIEN CR with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended. The risk of next-day psychomotor impairment is increased if AMBIEN CR is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if coadministered with other CNS depressants or alcohol; or coadministered with other drugs that increase the blood levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alertness if AMBIEN CR is taken in these circumstances [see Dosage and Administration (2), Clinical Studies (14.2)] . Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alertness, and impaired driving the morning after therapy. In order to minimize this risk a full night of sleep (7 8 hours) is recommended. Because AMBIEN CR can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.
Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.
Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with zolpidem should not be rechallenged with the drug.
Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including AMBIEN CR. Some of these changes included decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported. In controlled trials, <1% of adults with insomnia reported hallucinations. In a clinical trial, 7% of pediatric patients treated with Ambien 0.25 mg/kg taken at bedtime reported hallucinations versus 0% treated with placebo [see Use in Specific Populations (8.4)]. There have been postmarketing reports of delirium with zolpidem use [see Adverse Reactions (6.2)]. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed for the patient at any one time.
Although studies with 10 mg zolpidem tartrate did not reveal respiratory depressant effects at hypnotic doses in healthy subjects or in patients with mild to moderate chronic obstructive pulmonary disease (COPD), a reduction in the Total Arousal Index, together with a reduction in lowest oxygen saturation and increase in the times of oxygen desaturation below 80% and 90%, was observed in patients with mild to moderate sleep apnea when treated with zolpidem compared to placebo. Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if AMBIEN CR is prescribed to patients with compromised respiratory function or concomitant use with opioids or other CNS depressants. Postmarketing reports of respiratory insufficiency in patients receiving 10 mg of zolpidem tartrate, most of whom had pre-existing respiratory impairment, have been reported. The risk of respiratory depression should be considered prior to prescribing AMBIEN CR in patients with respiratory impairment including sleep apnea and myasthenia gravis or with concomitant opioid use [see Dosage and Administration (2.3), Drug Interactions (7.1)].
Drugs affecting GABA receptors, such as zolpidem tartrate, have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency. In addition, patients with hepatic insufficiency do not clear zolpidem tartrate as rapidly as patients with normal hepatic function. Avoid AMBIEN CR use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration (2.2), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)] .
There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence [see Drug Abuse and Dependence (9.2, 9.3)] .
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions (5.1)] CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2)] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions (5.4)] Abnormal Thinking and Behavior Changes [see Warnings and Precautions (5.5)] Withdrawal Effects [see Warnings and Precautions (5.9)] Most commonly observed adverse reactions (>10% in either elderly or adult patients) are: headache, next-day somnolence and dizziness ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Marketed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-AMBCRCP1
The following adverse reactions have been identified during postapproval use of AMBIEN CR. 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. 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). Psychiatric disorders:delirium
CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects ( 5.2, 7.1) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7, 7.1) Imipramine: Decreased alertness observed ( 7.1) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1) CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect ( 7.2) Ketoconazole: Combination use may increase effect ( 7.2)
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.
Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester. ( 8.1) Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after AMBIEN CR administration. ( 8.2) Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder. ( 5.5, 8.4)
AMBIEN CR is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established. In an 8-week study in pediatric patients (aged 6 17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. Psychiatric and nervous system disorders comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs 1.5%), headache (12.5% vs 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see Warnings and Precautions (5.5)] . Ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction. FDA has not required pediatric studies of AMBIEN CR in the pediatric population based on these efficacy and safety findings.
A total of 99 elderly ( 65 years of age) received daily doses of 6.25 mg AMBIEN CR in a 3-week placebo-controlled study. The adverse reaction profile of AMBIEN CR 6.25 mg in this population was similar to that of AMBIEN CR 12.5 mg in younger adults ( 64 years of age). Dizziness was reported in 8% of AMBIEN CR treated patients compared with 3% of those treated with placebo. The dose of AMBIEN CR in elderly patients is 6.25 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see Warnings and Precautions (5.2)] .
Women clear zolpidem tartrate from the body at a lower rate than men. C maxand AUC parameters of zolpidem from AMBIEN CR were, respectively, approximately 50% and 75% higher at the same dose in adult female subjects compared to adult male subjects. Between 6 and 12 hours after dosing, zolpidem concentrations were 2 to 3 fold higher in adult female compared to adult male subjects. Given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of AMBIEN CR for adult women is 6.25 mg, and the recommended dose for adult men is 6.25 or 12.5 mg. In geriatric patients, clearance of zolpidem is similar in men and women. The recommended dose of AMBIEN CR in geriatric patients is 6.25 mg regardless of gender.
The recommended dose of AMBIEN CR in patients with mild to moderate hepatic impairment is 6.25 mg once daily immediately before bedtime. Avoid AMBIEN CR use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration (2.2), Warnings and Precautions (5.8), Clinical Pharmacology (12.3)] .
Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. 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. Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. 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. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common. 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 effects were difficult to distinguish from placebo. 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.
Use of Ambien CR may lead to development of physical and/or psychological dependence. This risk of dependence increases with dose and duration of treatment. The risk of abuse and dependence is also greater in patients with history of alcohol or drug abuse. AMBIEN CR should be used with extreme caution in patients with current or past alcohol or drug abuse. 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. 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, convulsions, and delirium. The following adverse events, which are considered to meet the DSM-III-R criteria for uncomplicated sedative/hypnotic withdrawal, were reported during AMBIEN CR 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. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. There have been postmarketing reports of abuse, dependence and withdrawal with zolpidem.
In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.
General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions). As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that zolpidem is not dialyzable. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.
AMBIEN CR contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. AMBIEN CR (zolpidem tartrate) extended-release tablets is available in 6.25 mg and 12.5 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure: Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. AMBIEN CR consists of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.
Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of 1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.
Zolpidem binds to GABA A receptors with greater affinity for 1 subunit relative to 2 and 3 subunit containing receptors. Zolpidem has no appreciable binding affinity for 5 subunit containing GABA A receptors. This binding profile may explain the relative absence of myorelaxant effects in animal studies. Zolpidem has no appreciable binding affinity for dopaminergic D2, serotonergic 5HT 2, adrenergic, histaminergic or muscarinic receptors.
AMBIEN CR exhibits biphasic absorption characteristics, which results in rapid initial absorption from the gastrointestinal tract similar to zolpidem tartrate immediate-release, then provides extended plasma concentrations beyond three hours after administration. A study in 24 healthy male subjects was conducted to compare mean zolpidem plasma concentration-time profiles obtained after single oral administration of AMBIEN CR 12.5 mg and of an immediate-release formulation of zolpidem tartrate (10 mg). The terminal elimination half-life observed with AMBIEN CR (12.5 mg) was similar to that obtained with immediate-release zolpidem tartrate (10 mg). The mean plasma concentration-time profiles are shown in Figure 1. Figure 1: Mean Plasma Concentration-Time Profiles for AMBIEN CR (12.5 mg) and Immediate-Release Zolpidem Tartrate (10 mg) In adult and elderly patients treated with AMBIEN CR, there was no evidence of accumulation after repeated once-daily dosing for up to two weeks.
Impairment of Fertility Zolpidem was administered to rats at 4, 20, and 100 mg base/kg/day, which are approximately 4, 20, and 100 times the MRHD of 12.5 mg/day (10 mg zolpidem base) based on mg/m 2body surface area, prior to and during mating, and continuing in females through postpartum day 25. Zolpidem caused irregular estrus cycles and prolonged precoital intervals at the highest dose tested, which is approximately 100 times the MRHD based on mg/m 2body surface area. The NOAEL for these effects is 20 times the MRHD based on mg/m 2body surface area. There was no impairment of fertility at any dose tested.
AMBIEN CR was evaluated in three placebo-controlled studies for the treatment of patients with chronic primary insomnia (as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM IV ). Adult outpatients (18 64 years) with primary insomnia (N=212) were evaluated in a double-blind, randomized, parallel-group, 3-week trial comparing AMBIEN CR 12.5 mg and placebo. AMBIEN CR 12.5 mg decreased wake time after sleep onset (WASO) for the first 7 hours during the first 2 nights and for the first 5 hours after 2 weeks of treatment. AMBIEN CR 12.5 mg was superior to placebo on objective measures (polysomnography recordings) of sleep induction (by decreasing latency to persistent sleep [LPS]) during the first 2 nights of treatment and after 2 weeks of treatment. AMBIEN CR 12.5 mg was also superior to placebo on the patient reported global impression regarding the aid to sleep after the first 2 nights and after 3 weeks of treatment. Elderly outpatients ( 65 years) with primary insomnia (N=205) were evaluated in a double-blind, randomized, parallel-group, 3-week trial comparing AMBIEN CR 6.25 mg and placebo. AMBIEN CR 6.25 mg decreased wake time after sleep onset (WASO) for the first 6 hours during the first 2 nights and the first 4 hours after 2 weeks of treatment. AMBIEN CR 6.25 mg was superior to placebo on objective measures (polysomnography recordings) of sleep induction (by decreasing LPS) during the first 2 nights of treatment and after 2 weeks on treatment. AMBIEN CR 6.25 mg was superior to placebo on the patient reported global impression regarding the aid to sleep after the first 2 nights and after 3 weeks of treatment. In both studies, in patients treated with AMBIEN CR, polysomnography showed increased wakefulness at the end of the night compared to placebo-treated patients. In a 24-week double-blind, placebo controlled, randomized study in adult outpatients (18 64 years) with primary insomnia (N=1025), AMBIEN CR 12.5 mg administered as needed (3 to 7 nights per week) was superior to placebo over 24 weeks, on patient global impression regarding aid to sleep, and on patient-reported specific sleep parameters for sleep induction and sleep maintenance with no significant increased frequency of drug intake observed over time.
AMBIEN CR 6.25 mg extended-release tablets are composed of two layers* and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as: NDC Number Size 0713-5501-01 bottle of 100 AMBIEN CR 12.5 mg extended-release tablets are composed of two layers* and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as: NDC Number Size 0713-5521-01 bottle of 100 *Layers are covered by the coating and are indistinguishable.
Store between 15 C 25 C (59 F 77 F). Limited excursions permissible up to 30 C (86 F).
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with AMBIEN CR. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with AMBIEN CR and with each prescription refill. Review the AMBIEN CR Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that AMBIEN CR should be taken only as prescribed.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 8-2024 8-AMBCRCP1 MEDICATION GUIDE AMBIEN CR ( m'b - n see ahr) (zolpidem tartrate) extended-release tablets, for oral use, C-IV What is the most important information I should know about AMBIEN CR? AMBIEN CR may cause serious side effects, including: Complex sleep behaviors.After taking AMBIEN CR, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. These activities may happen with AMBIEN CR whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death. People taking AMBIEN CR have reported: sleep-walking sleep-driving making and eating food talking on the phone having sex Stop taking ABMIEN CR and tell your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN CR. What is AMBIEN CR? AMBIEN CR is a prescription sleep medicine used for the treatment of adults who have trouble falling asleep or staying asleep (insomnia). It is not known if AMBIEN CR is safe and effective in children under the age of 18 years. AMBIEN CR is not recommended for use in children under the age of 18 years. AMBIEN CR is a federally controlled substance (C-IV) because it can be abused or lead to dependence.Keep AMBIEN CR in a safe place to protect it from theft. Never give your AMBIEN CR to anyone else because it can cause death or harm them. Selling or giving away this medicine is against the law. Do not take AMBIEN CR if you: have had complex sleep behaviors that happened after taking AMBIEN CR in the past. See " What is the most important information I should know about AMBIEN CR? are allergic to zolpidem or any of the ingredients in AMBIEN CR. See the end of this Medication Guide for a complete list of ingredients in AMBIEN CR. Before taking AMBIEN CR, tell your healthcare provider about all of your medical conditions, including if you: have a history of depression, mental illness, or suicidal thoughts or actions have a history of drug or alcohol abuse or addiction have kidney or liver disease have a lung disease or breathing problems have sleep apnea have myasthenia gravis are pregnant or plan to become pregnant. Taking AMBIEN CR in the third trimester of pregnancy may harm your unborn baby. Tell your healthcare provider if you become pregnant or plan to become pregnant during treatment with AMBIEN CR. Babies born to mothers who take AMBIEN CR during the third trimester of pregnancy may have symptoms of breathing problems and sedation (such as sleepiness or low muscle tone). are breastfeeding or plan to breastfeed. AMBIEN CR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take AMBIEN CR. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AMBIEN CR and other medicines can interact with each other causing serious side effects. AMBIEN CR may affect the way other medicines work, and other medicines may affect how AMBIEN CR works. Especially tell your healthcare provider if you: take benzodiazepines take opioids as it may increase the risk of breathing problems (respiratory depression). take tricyclic antidepressants take other medicines that can make you sleepy or affect your breathing (including other zolpidem medicines) drink alcohol You can ask your pharmacist for a list of medicines that interact with AMBIEN CR. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take AMBIEN CR? Take AMBIEN CR exactly as prescribed.Do not change your dose on your own. Tell your healthcare provider if you think AMBIEN CR is not working for you. AMBIEN CR is for short-term use only.Treatment with AMBIEN CR should be as short as possible because the risk of dependence increases the longer you are being treated. Take 1AMBIEN CR tablet a night right before bedtime. Do not take AMBIEN CR if you are not able to stay in bed a full night (7 to 8 hours) before you must be active again. You should not take AMBIEN CR with or right after a meal. AMBIEN CR may help you fall asleep faster if you take it on an empty stomach. Do nottake AMBIEN CR if you drank alcohol that evening or before bed. Swallow AMBIEN CR tablets whole. Do not divide, crush, or chew AMBIEN CR tablets. If you cannot swallow AMBIEN CR tablets whole, tell your healthcare provider. You may need a different medicine. Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. If you take too much AMBIEN CR, call your healthcare provider or go to the nearest hospital emergency room right away. What are the possible side effects of AMBIEN CR? AMBIEN CR may cause serious side effects including: See " What is the most important information I should know about AMBIEN CR?" AMBIEN CR can make you sleepy or dizzy and can slow your thinking and motor skills.Next-day sleepiness is common, but can be serious. Because AMBIEN CR can make you sleepy or dizzy you are at a higher risk for falls. Do not drive, operate heavy machinery, or do other dangerous activities until you know how AMBIEN CR affects you. Do not drink alcohol or take opioids or other medicines that may make you sleepy or dizzy while taking AMBIEN CR without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, AMBIEN CR may make your sleepiness or dizziness much worse. Severe allergic reactions.Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking AMBIEN CR. Abnormal thoughts and behavior.Symptoms include more outgoing or aggressive behavior than normal, confusion (delirium), acting strangely, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions. Risk of suicide and worsening of depression.Worsening of depression, including suicidal thoughts and actions can happen during treatment with medicines like AMBIEN CR. Call your healthcare provider right away if you develop any thoughts of suicide, dying, or worsening depression during treatment with AMBIEN CR. Breathing problems.See " Before taking AMBIEN CR, tell your healthcare provider about all of your medical conditions, including if you :" Call your healthcare provider or get emergency medical help right away if you develop breathing problems during treatment with AMBIEN CR. Problems with your nervous system caused by severe liver disease (hepatic encephalopathy). Withdrawal symptoms.You may have withdrawal symptoms if you stop taking AMBIEN CR suddenly. Withdrawal symptoms can be serious and include stomach and muscle cramps, vomiting, sweating, shakiness, seizures, and confusion (delirium). Talk to your healthcare provider about slowly stopping AMBIEN CR to avoid withdrawal symptoms. The most common side effects of AMBIEN CR includeheadache and dizziness. These are not all the side effects of AMBIEN CR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088. How should I store AMBIEN CR? Store AMBIEN CR between at room temperature between 68 F to 77 F (20 C to 25 C). Keep AMBIEN CR and all medicines out of reach of children. General Information about the safe and effective use of AMBIEN CR. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMBIEN CR for a condition for which it was not prescribed. Do not give AMBIEN CR to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about AMBIEN CR that is written for healthcare professionals. What are the ingredients in AMBIEN CR? Active Ingredient:zolpidem tartrate Inactive Ingredients: The 6.25 mg tablets contain: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg tablets contain: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide. Marketed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Ambien and Ambien CR are registered trademarks of Cosette Pharmaceuticals, Inc. 2024 Cosette Pharmaceuticals, Inc. Other brands listed are the trademarks of their respective owners and are not trademarks of Cosette Pharmaceuticals, Inc. For more information, go to www.ambiencr.com or call 1-800-922-1038.
NDC0713-5501-01 AMBIENCR (ZOLPIDEM TARTRATE EXTENDED-RELEASE) CIV 6.25 mg Tablets Dispense with Medication Guide Rx only 100 Tablets Cosette PHARMACEUTICALS
NDC0713-5521-01 AMBIENCR (ZOLPIDEM TARTRATE EXTENDED-RELEASE) CIV 12.5 mg Tablets Dispense with Medication Guide Rx only 100 Tablets Cosette PHARMACEUTICALS