What Other Drugs Have The Same Makeup Of 12.5 Zolpidemb

What is Ambien CR and how is it used?

Ambien CR (zolpidem tartrate) is a sedative-hypnotic drug used to treat patients with insomnia and other issues with sleeping like maintaining slumber. The CR means extended release. Ambien CR is available in generic form.

What are side effects of Ambien CR?

Common side effects of Ambien CR include:

• daytime drowsiness,
• headache,
• dizziness,
• weakness,
• feeling "drugged,"
• lightheadedness,
• tired feeling,
• loss of coordination,
• stuffy nose,
• dry rima oris,
• nose or pharynx irritation,
• nausea,
• constipation,
• diarrhea,
• upset stomach,
• muscle hurting,
• depression, and
• unusual thinking, including thoughts of self-injury, anxiety, aggression, and risk-taking.

Tell your doctor if y'all have whatever exceptional but severe side furnishings of Ambien CR including:

• allergic reactions,
• chest pain,
• irregular heartbeats,
• dementia,
• blood clots, and
• peel reactions.

Unusual and dangerous "slumber driving" has occurred with a few patients.

DESCRIPTION

AMBIEN CR contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine form. AMBIEN CR (zolpidem tartrate extended-release tablets) is available in 6.25 mg and 12.v mg forcefulness tablets for oral administration.

Chemically, zolpidem is Northward,North,6-trimethyl-2-p-tolylimidazo[one,2-a] pyridine-3-acetamide Fifty-(+)tartrate (two:ane). Information technology has the following construction:

Zolpidem tartrate is a white to fair crystalline pulverisation that is sparingly soluble in water, booze, 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, reddish ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.v mg AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Bluish #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.

INDICATIONS

AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the handling of insomnia characterized past difficulties with slumber 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 upwards 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].

DOSAGE AND Administration

Dosage In Adults

Employ the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.five mg for men, taken only once per dark immediately earlier bedtime with at least 7-8 hours remaining before the planned time of enkindling. If the 6.25 mg dose is not effective, the dose tin can be increased to 12.five mg. In some patients, the college morning blood levels following use of the 12.5 mg dose increase the risk of side by side day impairment of driving and other activities that crave total alertness [come across WARNINGS AND PRECAUTIONS]. The full dose of AMBIEN CR should non exceed 12.five mg in one case daily immediately earlier bedtime. Ambien CR should be taken every bit a unmarried dose and should non exist readministered during the aforementioned night.

The recommended initial doses for women and men are unlike because zolpidem clearance is lower in women.

Special Populations

Elderly or devitalized patients may exist 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, Use in Specific Populations].

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 in one case daily immediately before bedtime. Avoid AMBIEN CR apply in patients with severe hepatic damage as information technology may contribute to encephalopathy [see WARNINGS AND PRECAUTIONS, Utilise in Specific Populations, CLINICAL PHARMACOLOGY].

Use With CNS Depressants

Dosage adjustment may be necessary when AMBIEN CR is combined with other CNS depressant drugs because of the potentially additive effects [come across WARNINGS AND PRECAUTIONS].

Administration

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 later a meal.

HOW SUPPLIED

Dosage Forms And Strengths

AMBIEN CR is bachelor 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 1 side.

Storage And Handling

AMBIEN CR 6.25 mg tablets are composed of 2 layers* and are coated, pinkish, round, arched, debossed with A~ on one side and supplied as:

NDC Number	Size
0024-5501-31	bottle of 100

AMBIEN CR 12.5 mg tablets are equanimous of ii layers* and are coated, bluish, circular, biconvex, debossed with A~ on one side and supplied every bit:

NDC Number	Size
0024-5521-31	bottle of 100
0024-5521-l	canteen of 500
0024-5521-10	carton of 30 unit of measurement dose

*Layers are covered by the blanket and are indistinguishable.

Store between 15°-25° C (59°-77°F). Limited excursions permissible up to xxx° C (86°F)

sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A SANOFI COMPANY. Revised: December 2016

SLIDESHOW

Sleep Disorders: Foods That Help Sleep or Keep You Awake Come across Slideshow

SIDE EFFECTS

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

• CNS-depressant effects and next-day damage [come across WARNINGS AND PRECAUTIONS]
• Serious anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
• Abnormal thinking and beliefs changes, and complex behaviors [see WARNINGS AND PRECAUTIONS]
• Withdrawal furnishings [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Associated With Discontinuation Of Treatment

In three-week clinical trials in adults and elderly patients ( > 65 years), three.5% (seven/201) patients receiving AMBIEN CR 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 was somnolence (1%).

In a 6-month study in adult patients (xviii-64 years of age), 8.5% (57/669) of patients receiving AMBIEN CR 12.v mg every bit compared to iv.6% on placebo (16/349) discontinued handling due to an adverse reaction. Reactions most ordinarily associated with discontinuation of AMBIEN CR included anxiety (anxiety, restlessness or agitation) reported in ane.5% (10/669) of patients as compared to 0.three% (1/349) of patients on placebo, and depression (low, major low 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 iv of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, standing or aggravated low, and manic reaction; one patient treated with placebo (n =97) was discontinued after an attempted suicide.

Near Commonly Observed Adverse Reactions In Controlled Trials

During treatment with AMBIEN CR in adults and elderly at daily doses of 12.v mg and six.25 mg, respectively, each for iii weeks, the virtually ordinarily observed adverse reactions associated with the use of AMBIEN CR were headache, side by side-twenty-four hours somnolence, and dizziness.

In the half dozen-month trial evaluating AMBIEN CR 12.5 mg, the adverse reaction contour was consistent with that reported in short-term trials, except for a higher incidence of anxiety (half dozen.3% for AMBIEN CR versus ii.6% for placebo).

Adverse Reactions Observed At An Incidence Of ≥ ane% In Controlled Trials

The post-obit tables enumerate treatment-emergent agin reaction frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received AMBIEN CR in placebo-controlled trials. Events reported past investigators were classified utilizing the MedDRA lexicon for the purpose of establishing issue frequencies. The prescriber should be enlightened 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 grouping of drug trials is conducted under a unlike set of conditions. Withal, 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 2 placebo-controlled efficacy trials involving AMBIEN CR. These trials involved patients with primary insomnia who were treated for 3 weeks with AMBIEN CR at doses of 12.5 mg (Table 1) or vi.25 mg (Table 2), respectively. The tables include only adverse reactions occurring at an incidence of at to the lowest degree 1% for AMBIEN CR 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/ Agin Reaction *	AMBIEN CR 12.v mg (N = 102)	Placebo (N = 110)
Infections and infestations
Influenza	3	0
Gastroenteritis	1	0
Labyrinthitis	1	0
Metabolism and diet disorders
Appetite disorder	1	0
Psychiatric disorders
Hallucinations **	4	0
Disorientation	iii	2
Anxiety	ii	0
Depression	2	0
Psychomotor retardation	2	0
Binge eating	i	0
Depersonalization	1	0
Disinhibition	1	0
Euphoric mood	1	0
Mood swings	i	0
Stress symptoms	1	0
Nervous organisation disorders
Headache	19	16
Somnolence	xv	2
Dizziness	12	v
Memory disorders ***	3	0
Balance disorder	ii	0
Disturbance in attending	2	0
Hypoesthesia	2	ane
Ataxia	1	0
Paresthesia	1	0
Middle disorders
Visual disturbance	3	0
Eye redness	two	0
Vision blurred	two	ane
Altered visual depth perception	ane	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	four
Constipation	2	0
Intestinal discomfort	1	0
Abdominal tenderness	one	0
Frequent bowel movements	one	0
Gastroesophageal reflux affliction	1	0
Vomiting	1	0
Skin and subcutaneous tissue disorders
Rash	1	0
Pare wrinkling	1	0
Urticaria	one	0
Musculoskeletal and connective tissue disorders
Back pain	four	3
Myalgia	four	0
Cervix pain	1	0
Reproductive system and chest disorders
Menorrhagia	ane	0
General disorders and assistants site conditions
Fatigue	3	2
Asthenia	i	0
Breast discomfort	1	0
Investigations
Blood pressure level increased	1	0
Trunk temperature increased	ane	0
Injury, poisoning and procedural complications
Contusion	1	0
Social circumstances
Exposure to poisonous plant	1	0
*Reactions reported past at least 1% of patients treated with AMBIEN CR and at greater frequency than in the placebo grouping. **Hallucinations included hallucinations NOS also as visual and hypnogogic hallucinations. ***Memory disorders include: memory impairment, amnesia, anterograde amnesia.

Table ii: 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 six.25 mg (N=99)	Placebo (N=106)
Infections and infestations
Nasopharyngitis	half dozen	four
Lower respiratory tract infection	ane	0
Otitis externa	i	0
Upper respiratory tract infection	ane	0
Psychiatric disorders
Feet	3	2
Psychomotor retardation	2	0
Apathy	1	0
Depressed mood	one	0
Nervous organization disorders
Headache	14	11
Dizziness	8	3
Somnolence	6	5
Burning awareness	ane	0
Dizziness postural	ane	0
Retention disorders **	1	0
Muscle contractions involuntary	1	0
Paresthesia	i	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 subcutaneous tissue disorders
Rash	1	0
Urticaria	1	0
Musculoskeletal and connective tissue disorders
Arthralgia	two	0
Muscle cramp	ii	1
Neck pain	ii	0
Renal and urinary disorders
Dysuria	1	0
Reproductive system and breast disorders
Vulvovaginal dryness	i	0
General disorders and administration site conditions
Flu similar disease	1	0
Pyrexia	i	0
Injury, poisoning and procedural complications
Cervix injury	1	0
*Reactions reported past at least 1% of patients treated with AMBIEN CR and at greater frequency than in the placebo grouping. **Memory disorders include: retentivity damage, amnesia, anterograde amnesia.

Dose Human relationship For Adverse Reactions

There is bear witness from dose comparison trials suggesting a dose human relationship for many of the adverse reactions associated with zolpidem use, especially for certain CNS and gastrointestinal adverse events.

Other Adverse Reactions Observed During The Premarketing Evaluation Of AMBIEN CR

Other treatment-emergent adverse reactions associated with participation in AMBIEN CR studies (those reported at frequencies of < i%) were not unlike in nature or frequency to those seen in studies with firsthand-release zolpidem tartrate, which are listed beneath.

Adverse Events Observed During The Premarketing Evaluation Of Immediate-Release Zolpidem Tartrate

Immediate-release zolpidem tartrate was administered to three,660 subjects in clinical trials throughout the U.South., Canada, and Europe. Handling-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 Earth Health System (WHO) dictionary of preferred terms.

The frequencies presented, therefore, stand for the proportions of the 3,660 individuals exposed to zolpidem, at all doses, who experienced an consequence of the blazon cited on at least ane occasion while receiving zolpidem. All reported treatment-emergent agin events are included, except those already listed in the table to a higher place of adverse events in placebo-controlled studies, those coding terms that are and so full general as to be uninformative, and those events where a drug cause was remote. Information technology is important to emphasize that, although the events reported did occur during handling with AMBIEN, they were not necessarily caused by it.

Adverse events are farther classified within body system categories and enumerated in order of decreasing frequency using the post-obit definitions: frequent adverse events are defined every bit those occurring in greater than 1/100 subjects; infrequent agin events are those occurring in i/100 to 1/1,000 patients; rare events are those occurring in less than one/1,000 patients.

Autonomic nervous organisation: Frequent: dry mouth. Infrequent: increased sweating, pallor, postural hypotension, syncope. Rare: abnormal adaptation, contradistinct saliva, flushing, glaucoma, hypotension, impotence, increased saliva, tenesmus.

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

Cardiovascular organisation: 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: aberrant gait, abnormal thinking, aggressive reaction, apathy, ambition 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 arrangement: 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 organisation: Rare: anemia, hyperhemoglobinemia, leukopenia, lymphadenopathy, macrocytic anemia, purpura, thrombosis.

Immunologic organization: Infrequent: infection. Rare: abscess canker simplex canker zoster, otitis externa, otitis media.

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

Metabolic and nutritional: Infrequent: hyperglycemia, thirst. Rare: gout, hypercholesteremia, hyperlipidemia, increased element of group i phosphatase, increased BUN, periorbital edema.

Musculoskeletal organization: Exceptional: arthritis. Rare: arthrosis, musculus weakness, sciatica, tendinitis.

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

Respiratory system: Frequent: sinusitis. Infrequent: bronchitis, coughing, dyspnea. Rare: bronchospasm, respiratory low, 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. Exceptional: eye irritation, middle hurting, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation aberrant, parosmia, photopsia.

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

Postmarketing Feel

The following adverse reactions take been identified during mail service-approval utilize of AMBIEN CR. Because these reactions are reported voluntarily from a population of uncertain size, information technology is non ever possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Liver and biliary system: astute hepatocellular, cholestatic or mixed liver injury with or without jaundice (i.east., bilirubin > 2x ULN, alkaline phosphatase ≥ 2x ULN, transaminase ≥ 5x ULN).

DRUG INTERACTIONS

CNS-agile Drugs

Co-administration of zolpidem with other CNS depressants increases the risk of CNS low. Concomitant utilize of zolpidem with these drugs may increment drowsiness and psychomotor impairment, including impaired driving ability. [see WARNINGS AND PRECAUTIONS]. Zolpidem tartrate was evaluated in good for you volunteers in unmarried-dose interaction studies for several CNS drugs.

Imipramine, Chlorpromazine

Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an condiment 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 [see CLINICAL PHARMACOLOGY].

Haloperidol

A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following unmarried-dose assistants does not predict the absence of an effect following chronic administration [see CLINICAL PHARMACOLOGY].

Alcohol

An additive adverse result on psychomotor functioning between alcohol and oral zolpidem was demonstrated [see WARNINGS AND PRECAUTIONS].

Sertraline Concomitant administration of zolpidem and sertraline increases exposure to zolpidem [see CLINICAL PHARMACOLOGY].

Fluoxetine

After multiple doses of zolpidem tartrate and fluoxetine an increase in the zolpidem half-life (17%) was observed. There was no evidence of an additive effect in psychomotor performance [run into CLINICAL PHARMACOLOGY].

Drugs That Bear upon Drug Metabolism Via Cytochrome P450

Some compounds known to induce or inhibit CYP3A may impact exposure to zolpidem. The effect of drugs that induce or inhibit other P450 enzymes on the exposure to zolpidem is not known.

CYP3A4 Inducers

Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem. Use of CYP3A4 inducers in combination with zolpidem may subtract the efficacy of zolpidem [see CLINICAL PHARMACOLOGY].

CYP3A4 Inhibitors

Ketoconazole, a potent CYP3A4 inhibitor, increased the exposure to and pharmacodynamic furnishings of zolpidem. Consideration should be given to using a lower dose of zolpidem when a potent CYP3A4 inhibitor and zolpidem are given together [encounter CLINICAL PHARMACOLOGY].

Drug Abuse And Dependence

Controlled Substance

Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation.

Corruption

Abuse and habit are separate and singled-out from physical dependence and tolerance. Abuse is characterized past misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a country 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: dumb command over drug employ, compulsive use, continued utilize despite damage, and craving. Drug habit is a treatable affliction, using a multidisciplinary approach, simply relapse is common.

Studies of abuse potential in onetime drug abusers found that the furnishings of single doses of zolpidem tartrate 40 mg were similar, simply not identical, to diazepam 20 mg, while zolpidem tartrate ten mg effects were difficult to distinguish from placebo.

Because persons with a history of addiction to, or corruption of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored advisedly when receiving zolpidem or any other hypnotic.

Dependence

Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can exist produced by precipitous abeyance, rapid dose reduction, decreasing blood level of the drug, and/or assistants of an antagonist.

Allaying/hypnotics have produced withdrawal signs and symptoms post-obit abrupt discontinuation. These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, airsickness, sweating, tremors, and convulsions. The following agin events, which are considered to run across the DSMIII-R criteria for uncomplicated sedative/hypnotic withdrawal, were reported during U.S. clinical trials following placebo substitution occurring within 48 hours post-obit last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and intestinal discomfort. These reported adverse events occurred at an incidence of 1% or less. However, available data cannot provide a reliable approximate of the incidence, if whatsoever, of dependence during treatment at recommended doses. Mail-marketing reports of abuse, dependence and withdrawal have been received.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

CNS Depressant Effects And Side by side-Mean solar day Harm

AMBIEN CR is a central nervous organisation (CNS) depressant and can impair daytime function in some patients even when used every bit prescribed. Prescribers should monitor for excess depressant effects, only impairment can occur in the absence of subjective symptoms, and may not be reliably detected past ordinary clinical exam (i.east. 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 consummate mental alertness the twenty-four hour period afterward employ.

Additive furnishings occur with concomitant utilize of other CNS depressants (east.g. benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of AMBIEN CR and concomitant CNS depressants should be considered [run across DOSAGE AND Administration].

The use of AMBIEN CR with other allaying-hypnotics (including other zolpidem products) at bedtime or the eye of the night is not recommended.

The risk of next-day psychomotor impairment is increased if AMBIEN CR is taken with less than a total night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if co-administered with other CNS depressants or alcohol; or co-administered with other drugs that increase the blood levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alacrity if Ambien CR is taken in these circumstances [encounter DOSAGE AND Administration and Clinical Studies].

Vehicle drivers and machine operators should be warned that, as with other hypnotics, in that location may be a possible gamble of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alacrity and impaired driving the morning afterwards therapy. In order to minimize this risk a full night of sleep (7-viii hours) is recommended.

Need To Evaluate For Co-morbid Diagnoses

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic handling of insomnia should be initiated but after a careful evaluation of the patient. The failure of indisposition to remit later on 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 beliefs abnormalities may be the outcome of an unrecognized psychiatric or concrete disorder. Such findings take emerged during the course of treatment with sedative/hypnotic drugs, including zolpidem.

Severe Anaphylactic And Anaphylactoid Reactions

Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of allaying-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 afterwards treatment with zolpidem should not be rechallenged with the drug.

Aberrant Thinking And Behavioral Changes

Abnormal thinking and beliefs 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 graphic symbol), bizarre beliefs, agitation and depersonalization. Visual and auditory hallucinations have been reported.

In controlled trials, < ane% 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].

Circuitous behaviors such as "sleep-driving" (i.east., driving while non fully awake after ingestion of a sedative-hypnotic, with amnesia for the outcome) have been reported in sedative-hypnotic-naive every bit well as in sedative-hypnotic-experienced persons. Although behaviors such as "sleep-driving" have occurred with AMBIEN CR alone at therapeutic doses, the co-administration of booze and other CNS depressants increases the risk of such behaviors, equally does the use of AMBIEN CR at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of AMBIEN CR should exist strongly considered for patients who study a "sleep-driving" episode.

Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) accept been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may besides occur.

It tin rarely exist determined with certainty whether a particular case of the aberrant behaviors listed to a higher place is drug induced, spontaneous in origin, or a consequence of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and firsthand evaluation.

Employ In Patients With Depression

In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and deportment (including completed suicides), have been reported. Suicidal tendencies may exist nowadays in such patients and protective measures may be required. Intentional overdosage is more than common in this grouping of patients; therefore, the lowest number of tablets that is feasible should be prescribed for the patient at any one time.

Respiratory Depression

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 Alphabetize, 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 slumber apnea when treated with zolpidem compared to placebo. Since sedative-hypnotics have the chapters to depress respiratory drive, precautions should be taken if AMBIEN CR is prescribed to patients with compromised respiratory part. Post-marketing reports of respiratory insufficiency in patients receiving 10 mg of zolpidem tartrate, most of whom had pre-existing respiratory impairment, take been reported. The risk of respiratory low should exist considered prior to prescribing AMBIEN CR in patients with respiratory impairment including sleep apnea and myasthenia gravis.

Precipitation Of Hepatic Encephalopathy

GABA agonists such every bit zolpidem tartrate have been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency. In add-on, patients with hepatic insufficiency do not clear zolpidem tartrate equally rapidly as patients with normal hepatic office. Avoid AMBIEN CR apply in patients with astringent hepatic damage equally it may contribute to encephalopathy [see DOSAGE AND ADMINISTRATION, Apply in Specific Populations, CLINICAL PHARMACOLOGY].

Withdrawal Effects

At that place have been reports of withdrawal signs and symptoms following the rapid dose subtract or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence [see Drug Abuse and Dependence].

Severe Injuries

Zolpidem can crusade drowsiness and a decreased level of consciousness, which may atomic number 82 to falls and consequently to severe injuries. Severe injuries such every bit hip fractures and intracranial hemorrhage accept been reported.

Patient Counseling Information

Advise patients 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 handling 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 merely equally prescribed.

CNS Depressant Effects And Next-Solar day Impairment

Tell patients that AMBIEN CR can cause next-solar day damage fifty-fifty when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed. Caution patients against driving and other activities requiring complete mental alertness the day after employ. Inform patients that impairment can exist present despite feeling fully awake.

Severe Anaphylactic And Anaphylactoid Reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and propose patients to seek medical attending immediately if any of them occur.

Sleep-driving And Other Complex Behaviors

Instruct patients and their families that allaying hypnotics can crusade abnormal thinking and behavior change, including "sleep driving" and other complex behaviors while not existence fully awake (preparing and eating food, making phone calls, or having sexual practice). Tell patients to phone call you immediately if they develop any of these symptoms.

Suicide

Tell patients to immediately written report any suicidal thoughts.

Alcohol And Other Drugs

Ask patients almost alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients non to use AMBIEN CR if they drank booze that evening or before bed.

Tolerance, Corruption, And Dependence

Tell patients not to increase the dose of AMBIEN CR on their ain, and to inform you if they believe the drug "does not piece of work".

Administration Instructions

Patients should be counseled to take AMBIEN CR right before they become into bed and only when they are able to stay in bed a total night (7-8 hours) before beingness active again. AMBIEN CR tablets should not be taken with or immediately afterwards a meal. Advise patients NOT to have AMBIEN CR if they drank alcohol that evening.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis

Zolpidem was administered to mice and rats for 2 years at oral doses of iv, 18, and 80 mg base/kg. In mice, these doses are approximately 2, 9, and forty times the maximum recommended human dose (MRHD) of 12.5 mg/solar day (x mg zolpidem base) on mg/m² ground. In rats, these doses are approximately 4, eighteen, and 80 times the MRHD on a mg/g² ground. No show of carcinogenic potential was observed in mice. In rats, renal tumors (lipoma, liposarcoma) were seen at the mid-and high doses.

Mutagenesis

Zolpidem was negative in in vitro (bacterial reverse mutation, mouse lymphoma, and chromosomal aberration) and in vivo (mouse micronucleus) genetic toxicology assays.

Damage Of fertility

Oral assistants of zolpidem (doses of 4, 20, and 100 mg base/kg/mean solar day) to rats prior to and during mating, and continuing in females through postpartum day 25, resulted in irregular heat cycles and prolonged precoital intervals at the highest dose tested. The no-event dose for these findings is approximately xx times the MRHD on a mg/k² footing. In that location was no impairment of fertility at any dose tested.

Utilise In Specific Populations

Pregnancy

Pregnancy Category C

There are no acceptable and well-controlled studies of AMBIEN CR in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of astringent neonatal respiratory low have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal menstruum. Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. AMBIEN CR should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Assistants of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the AMBIEN CR maximum recommended homo dose (MRHD) of 12.5 mg/twenty-four hour period (approximately 10 mg/day zolpidem base); however, teratogenicity was not observed.

When zolpidem was administered at oral doses of four, 20, and 100 mg base/kg/solar day to meaning rats during the period of organogenesis, dose-related decreases in fetal skull ossification occurred at all simply the lowest dose, which is approximately four times the MRHD on a mg/m² basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and xvi mg base of operations/kg/day, increased embryo-fetal death and incomplete fetal skeletal ossification occurred at the highest dose. The no-effect dose for embryo-fetal toxicity in rabbits is approximately eight times the MRHD on a mg/m² basis. Assistants of zolpidem to rats at oral doses of four, 20, and 100 mg base/kg/day during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately iv times the MRHD on a mg/m² footing.

Labor And Delivery

AMBIEN CR has no established use in labor and delivery [run across Pregnancy].

Nursing Mothers

Zolpidem is excreted in human milk. Caution should exist exercised when AMBIEN CR is administered to a nursing woman.

Pediatric Use

AMBIEN CR is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients beneath the age of 18 years accept not been established.

In an eight-week report in pediatric patients (aged half dozen-17 years) with insomnia associated with attention-arrears/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did non decrease sleep latency compared to placebo. Psychiatric and nervous system disorders comprised the near frequent ( > v%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.v%), headache (12.5% vs. nine.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]. 10 patients on zolpidem (7.4%) discontinued handling 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.

Geriatric Use

A total of 99 elderly ( ≥ 65 years of age) received daily doses of 6.25 mg AMBIEN CR in a 3week placebo-controlled report. The adverse reaction contour 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 historic period). Dizziness was reported in 8% of AMBIEN CR-treated patients compared with iii% of those treated with placebo.

The dose of AMBIEN CR in elderly patients is six.25 mg to minimize adverse furnishings related to impaired motor and/or cognitive performance and unusual sensitivity to allaying/hypnotic drugs [encounter WARNINGS AND PRECAUTIONS].

Gender Difference In Pharmacokinetics

Women clear zolpidem tartrate from the body at a lower rate than men. Cmax and AUC parameters of zolpidem from AMBIEN CR were, respectively, approximately 50% and 75% higher at the aforementioned dose in adult female subjects compared to adult male subjects. Betwixt 6 and 12 hours subsequently dosing, zolpidem concentrations were two-to 3 fold college in woman compared to adult male subjects. Given the college blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of AMBIEN CR for developed women is 6.25 mg, and the recommended dose for developed men is 6.25 or 12.five 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.

Hepatic Impairment

The recommended dose of AMBIEN CR in patients with mild to moderate hepatic impairment is vi.25 mg one time daily immediately before bedtime. Avoid AMBIEN CR apply in patients with severe hepatic impairment every bit it may contribute to encephalopathy [meet DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

Overdosage & Contraindications

OVERDOSE

Signs And Symptoms

In postmarketing experience of overdose with zolpidem tartrate solitary, 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.

Recommended Treatment

General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Zolpidem's allaying 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). Equally in all cases of drug overdose, respiration, pulse, blood pressure, and other advisable signs should exist monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should exist withheld following zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has non 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 exist considered. The physician may wish to consider contacting a poison control middle for up-todate information on the management of hypnotic drug product overdosage.

CONTRAINDICATIONS

AMBIEN CR is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS].

CLINICAL PHARMACOLOGY

Mechanism Of Activity

Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic backdrop. It interacts with a GABA-BZ receptor circuitous and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits. This selective bounden of zolpidem on the BZ1 receptor is not absolute, only it may explicate the relative absenteeism of myorelaxant and anticonvulsant furnishings in animal studies too equally the preservation of deep sleep (stages 3 and four) in man studies of zolpidem tartrate at hypnotic doses.

Pharmacokinetics

AMBIEN CR exhibits biphasic absorption characteristics, which results in rapid initial absorption from the gastrointestinal tract similar to zolpidem tartrate immediate-release, so provides extended plasma concentrations beyond three hours subsequently assistants. A written report in 24 salubrious male subjects was conducted to compare mean zolpidem plasma concentration-time profiles obtained subsequently single oral administration of AMBIEN CR 12.5 mg and of an immediate-release formulation of zolpidem tartrate (ten mg). The terminal elimination one-half-life observed with AMBIEN CR (12.five mg) was similar to that obtained with immediate-release zolpidem tartrate (10 mg). The mean plasma concentration-time profiles are shown in Effigy 1.

Figure 1: Hateful plasma concentration-time profiles for AMBIEN CR (12.5 mg) and immediate-release zolpidem tartrate (ten mg)

In adult and elderly patients treated with AMBIEN CR, there was no evidence of aggregating afterward repeated once-daily dosing for up to two weeks.

Absorption

Following assistants of AMBIEN CR, administered as a single 12.5 mg dose in healthy male adult subjects, the mean pinnacle concentration (Cmax) of zolpidem was 134 ng/mL (range: 68.nine to 197 ng/ml) occurring at a median time (Tmax) of 1.5 hours. The hateful AUC of zolpidem was 740 ng•hr/mL (range: 295 to 1359 ng•hr/mL).

A nutrient-effect report in 45 healthy subjects compared the pharmacokinetics of AMBIEN CR 12.5 mg when administered while fasting or within thirty minutes after a meal. Results demonstrated that with food, mean AUC and Cmax were decreased past 23% and 30%, respectively, while median Tmax was increased from 2 hours to 4 hours. The half-life was non changed. These results suggest that, for faster sleep onset, AMBIEN CR should not exist administered with or immediately afterward a repast.

Distribution

Total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL.

Metabolism

Zolpidem is converted to inactive metabolites that are eliminated primarily by renal excretion.

Emptying

When AMBIEN CR was administered as a single 12.5 mg dose in healthy male developed subjects, the mean zolpidem emptying half-life was 2.8 hours (range: 1.62 to 4.05 hr).

Special Populations

Elderly

In 24 elderly ( ≥ 65 years) healthy subjects administered a single six.25 mg dose of AMBIEN CR, the mean pinnacle concentration (Cmax) of zolpidem was seventy.6 (range: 35.0 to 161) ng/mL occurring at a median time (Tmax) of 2.0 hours. The hateful AUC of zolpidem was 413 ng•hr/mL (range: 124 to 1190 ng•60 minutes/mL) and the hateful elimination one-half-life was 2.9 hours (range: 1.59 to 5.50 hours).

Hepatic Impairment

AMBIEN CR was non studied in patients with hepatic impairment. The pharmacokinetics of an immediate-release formulation of zolpidem tartrate in 8 patients with chronic hepatic insufficiency were compared to results in healthy subjects. Following a single twenty-mg oral zolpidem tartrate dose, mean Cmax and AUC were found to be ii times (250 vs. 499 ng/mL) and five times (788 vs. iv,203 ng•hr/mL) higher, respectively, in hepatically compromised patients. Tmax did non change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.ane to 25.8 hr) was greater than that observed in normal subjects of ii.ii hour (range: 1.6 to 2.iv 60 minutes) [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, Employ in Specific Populations].

Renal Damage

AMBIEN CR was non studied in patients with renal impairment. The pharmacokinetics of an immediate-release formulation of zolpidem tartrate were studied in 11 patients with cease-stage renal failure (mean ClCr = six.v ± 1.five mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem tartrate 10 mg orally each day for 14 or 21 days. No statistically significant differences were observed for Cmax, Tmax, half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. Zolpidem was non hemodialyzable. No accumulation of unchanged drug appeared later fourteen or 21 days. Zolpidem pharmacokinetics were not significantly different in renally-impaired patients. No dosage aligning is necessary in patients with compromised renal function.

Drug Interactions

CNS-depressants

Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see WARNINGS AND PRECAUTIONS]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a xx% decrease in summit levels of imipramine, but at that place was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an condiment effect of decreased alacrity and psychomotor performance.

A written report involving haloperidol and zolpidem revealed no upshot of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction post-obit single-dose administration does non predict the absence of an event following chronic assistants.

An additive adverse effect on psychomotor functioning between alcohol and oral zolpidem was demonstrated [see WARNINGS AND PRECAUTIONS].

Following five consecutive nightly doses at bedtime of oral zolpidem tartrate 10 mg in the presence of sertraline l mg (17 consecutive daily doses, at 7:00 am, in healthy female volunteers), zolpidem Cmax was significantly higher (43%) and Tmax was significantly decreased (-53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem.

A unmarried-dose interaction study with zolpidem tartrate ten mg and fluoxetine 20 mg at steady-country levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of zolpidem and fluoxetine were given at steady state and the concentrations evaluated in healthy females, an increase in the zolpidem half-life (17%) was observed. In that location was no evidence of an condiment consequence in psychomotor performance.

Drugs That Affect Drug Metabolism Via Cytochrome P450

Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes on the pharmacokinetics of zolpidem is unknown.

A single-dose interaction study with zolpidem tartrate 10 mg and itraconazole 200 mg at steady-state levels in male volunteers resulted in a 34% increase in AUC0-∞of zolpidem tartrate. There were no pharmacodynamic furnishings of zolpidem detected on subjective drowsiness, postural sway, or psychomotor performance.

A single-dose interaction study with zolpidem tartrate 10 mg and rifampin 600 mg at steady-state levels in female subjects showed significant reductions of the AUC (-73%), Cmax (-58%), and T½ (-36 %) of zolpidem together with significant reductions in the pharmacodynamic effects of zolpidem tartrate. Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem [encounter DRUG INTERACTIONS].

A single-dose interaction study with zolpidem tartrate 5 mg and ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased Cmax of zolpidem (30%) and the full AUC of zolpidem (70%) compared to zolpidem alone and prolonged the elimination half-life (30 %) along with an increase in the pharmacodynamic effects of zolpidem [run across DRUG INTERACTIONS].

Additionally, fluvoxamine (a strong inhibitor of CYP1A2 and a weak inhibitor of CYP3A4 and CYP2C9) and ciprofloxacin (a strong inhibitor of CYP1A2 and a moderate inhibitor of CYP3A4) are also likely to inhibit zolpidem's metabolic pathways, potentially leading to an increase in zolpidem exposure.

Other Drugs With No Interactions With Zolpidem

A study involving cimetidine/zolpidem tartrate and ranitidine/zolpidem tartrate combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.

Zolpidem tartrate had no effect on digoxin pharmacokinetics and did non bear on prothrombin time when given with warfarin in good for you subjects.

Clinical Studies

Controlled Clinical Trials

AMBIEN CR was evaluated in three placebo-controlled studies for the treatment of patients with chronic primary insomnia (as divers in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM Four).

Adult outpatients (18-64 years) with main insomnia (Due north=212) were evaluated in a double-bullheaded, randomized, parallel-grouping, three-week trial comparison AMBIEN CR 12.five mg and placebo. AMBIEN CR 12.5 mg decreased wake time later sleep onset (WASO) for the get-go 7 hours during the first 2 nights and for the showtime 5 hours after 2 weeks of treatment. AMBIEN CR 12.v 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 handling and after two weeks of handling. AMBIEN CR 12.v mg was as well superior to placebo on the patient reported global impression regarding the aid to sleep afterwards the first two nights and after 3 weeks of treatment.

Elderly outpatients ( ≥ 65 years) with primary insomnia (N=205) were evaluated in a double-blind, randomized, parallel-grouping, 3-week trial comparing AMBIEN CR 6.25 mg and placebo. AMBIEN CR half dozen.25 mg decreased wake time after slumber onset (WASO) for the offset 6 hours during the first 2 nights and the first iv hours later on 2 weeks of treatment. AMBIEN CR 6.25 mg was superior to placebo on objective measures (polysomnography recordings) of slumber induction (past decreasing LPS) during the starting time two nights of handling and afterwards 2 weeks on handling. AMBIEN CR half-dozen.25 mg was superior to placebo on the patient reported global impression regarding the assistance to slumber after the first two 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 dark compared to placebo-treated patients.

In a 24-week double-bullheaded, placebo controlled, randomized written report in adult outpatients (eighteen-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 slumber parameters for slumber induction and slumber maintenance with no meaning increased frequency of drug intake observed over time.

Studies Pertinent To Safety Concerns For Sedative/Hypnotic Drugs

Next-twenty-four hour period Residual Effects

In 5 clinical studies [three controlled studies in adults (eighteen-64 years of age) administered AMBIEN CR 12.5 mg and two controlled studies in the elderly ( ≥ 65 years of age) administered AMBIEN CR 6.25 mg or 12.5 mg], the effect of AMBIEN CR on vigilance, memory, or motor office were assessed using neurocognitive tests. In these studies, no significant decrease in performance was observed eight hours subsequently a nighttime dose. In add-on, no evidence of side by side-solar day residual furnishings was detected with AMBIEN CR 12.5 mg and 6.25 mg using self-ratings of sedation.

During the 3-week studies, next-twenty-four hour period somnolence was reported past xv% of the adult patients who received 12.5 mg AMBIEN CR versus 2% of the placebo grouping; adjacent-day somnolence was reported past six% of the elderly patients who received 6.25 mg AMBIEN CR versus 5% of the placebo group [come across ADVERSE REACTIONS]. In a 6-month study, the overall incidence of next-day somnolence was five.7% in the AMBIEN CR group equally compared to 2% in the placebo group.

Rebound Furnishings

Rebound indisposition, defined as a dose-dependent worsening in sleep parameters (latency, sleep efficiency, and number of awakenings) compared with baseline following discontinuation of treatment, is observed with brusque-and intermediate-acting hypnotics. In the ii 3-week placebo-controlled studies in patients with master insomnia, a rebound consequence was only observed on the start night later on abrupt discontinuation of AMBIEN CR. On the second nighttime, there was no worsening compared to baseline in the AMBIEN CR grouping.

In a 6-month placebo-controlled written report in which AMBIEN CR was taken every bit needed (3 to 7 nights per week), within the first calendar month a rebound event was observed for Total Sleep Fourth dimension (not for WASO) during the first night off medication. After this beginning month menstruum, no farther rebound insomnia was observed. Afterward concluding treatment discontinuation no rebound was observed.

PATIENT Information

AMBIEN CR®
(am'exist-en see ahr)
(zolpidem tartrate) Extended-release Tablets

Read the Medication Guide that comes with AMBIEN CR before you outset taking it and each time you get a refill. There may be new data. This Medication Guide does not accept the place of talking to your healthcare provider about your medical condition or treatment.

What is the virtually important information I should know virtually AMBIEN CR?

• Do not accept more AMBIEN CR than prescribed.
• Practice non take AMBIEN CR unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
• Take AMBIEN CR right before you go far bed, not sooner.

AMBIEN CR may cause serious side furnishings that you may not know are happening to y'all. These side effects include:

• sleepiness during the 24-hour interval
• not thinking clearly
• act strangely, confused, or upset
•  "sleep-walking" or doing other activities when you are comatose like:
  • eating
  • talking
  • having sex
  • driving a motorcar

Call your healthcare provider right abroad if you find out that you lot have washed any of the above activities after taking AMBIEN CR.

You should not bulldoze a car or do things that require clear thinking the day after yous accept AMBIEN CR.

Do not accept AMBIEN CR if you:

• drank alcohol that evening or before bed
• take other medicines that tin can make you sleepy. Taking AMBIEN CR with other drugs can cause side effects. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you lot if you lot can take AMBIEN CR with your other medicines.
• cannot get a full night'southward sleep

What is AMBIEN CR?

AMBIEN CR is a sedative-hypnotic (slumber) medicine. AMBIEN CR is used in adults for the handling of a sleep trouble called insomnia. Symptoms of indisposition include:

• problem falling asleep
• waking up oft during the night

It is not known if AMBIEN CR is safe and effective in children under the historic period of xviii years.

AMBIEN CR is a federally controlled substance (C-Iv) because information technology can be driveling or pb to dependence. Keep AMBIEN CR in a prophylactic identify to preclude misuse and corruption. Selling or giving away AMBIEN CR may harm others, and is against the police force. Tell your healthcare provider if you accept ever driveling or have been dependent on alcohol, prescription medicines or street drugs.

Who should not take AMBIEN CR?

• Do not take AMBIEN CR if you are allergic to zolpidem or any other ingredients in AMBIEN CR. Come across the end of this Medication Guide for a complete list of ingredients in AMBIEN CR.
• Do not accept AMBIEN CR if you have had an allergic reaction to drugs containing zolpidem, such equally Ambien, Edluar, Zolpimist, or Intermezzo.

Symptoms of a serious allergic reaction to zolpidem can include:

• swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

What should I tell my healthcare provider before taking AMBIEN CR?

AMBIEN CR may non exist right for you lot. Before starting AMBIEN CR, tell your healthcare provider nigh all of your health atmospheric condition, including if yous:

• have a history of low, mental disease, or suicidal thoughts
• accept a history of drug or alcohol corruption or addiction
• have kidney or liver illness
• accept a lung affliction or breathing problems
• are significant, planning to become meaning. Information technology is not known if AMBIEN CR will harm your unborn baby.
• are breastfeeding or programme to breastfeed. AMBIEN CR tin laissez passer into your breast milk. It is non known if AMBIEN CR will harm your babe. 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 nonprescription medicines, vitamins and herbal supplements.

Medicines tin can collaborate with each other, sometimes causing serious side effects. Do non have AMBIEN CR with other medicines that can make yous sleepy unless your healthcare provider tells you to.

Know the medicines you take. Go on a list of your medicines with y'all to evidence your healthcare provider and pharmacist each time you get a new medicine.

How should I take AMBIEN CR?

• Run across "What is the nearly important information I should know nearly AMBIEN CR?"
• Accept AMBIEN CR exactly equally prescribed. Only take 1 AMBIEN CR tablet a dark if needed.
• Do not take AMBIEN CR if you drank alcohol that evening or earlier bed.
• You should not take AMBIEN CR with or right after a repast. AMBIEN CR may help you fall comatose faster if you take it on an empty stomach.
• Have AMBIEN CR Tablets whole. Do not intermission, crush, dissolve or chew AMBIEN CR tablets earlier swallowing. If you lot cannot eat AMBIEN CR tablets whole, tell your healthcare provider. You lot may demand a different medicine.
• Phone call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that in that location is another condition causing your sleep issues.
• If you lot have too much AMBIEN CR or overdose, get emergency treatment.

What are the possible side effects of AMBIEN CR?

AMBIEN CR may cause serious side effects including:

• getting out of bed while non being fully awake and doing an activeness that you practice not know you are doing. (See "What is the virtually of import information I should know about AMBIEN CR?")
• abnormal thoughts and behavior. Symptoms include more than outgoing or aggressive beliefs than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
• retentivity loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if y'all go these symptoms subsequently taking AMBIEN CR.
• falls, which may lead to astringent injuries

Call your healthcare provider right away if you have whatever of the above side furnishings or any other side furnishings that worry y'all while using AMBIEN CR.

The most common side furnishings of AMBIEN CR are:

• headache
• sleepiness
• dizziness
• drowsiness the side by side mean solar day after you take AMBIEN CR

After you cease taking a sleep medicine, you may have symptoms for ane to two days such as:

• problem sleeping
• nausea
• flushing
• lightheadedness
• uncontrolled crying
• vomiting
• stomach cramps
• panic attack
• nervousness
• breadbasket expanse pain

These are not all the side furnishings of AMBIEN CR. Inquire your healthcare provider or pharmacist for more information.

Phone call your healthcare provider for medical advice most side effects. You lot may written report side effects to FDA at ane-800-FDA-1088.

How should I store AMBIEN CR?

Store AMBIEN CR at room temperature, 59°F to 77°F (fifteen°C to 25° C).

Keep AMBIEN CR and all medicines out of achieve of children.

Full general Information most 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 information technology was not prescribed. Do non share AMBIEN CR with other people, even if you call back they have the same symptoms that you accept. It may harm them and it is confronting the police force.

This Medication Guide summarizes the about important information about AMBIEN CR. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or chemist for data well-nigh AMBIEN CR that is written for healthcare professionals.

For more information, become to www.ambiencr.com or call 1-800-633-1610.

What are the ingredients in AMBIEN CR?

Agile Ingredient: Zolpidem tartrate

Inactive Ingredients:

The 6.25 mg tablets comprise: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, carmine ferric oxide, sodium starch glycolate, and titanium dioxide.

The 12.5 mg tablets contain: colloidal silicon dioxide, FD&C Blueish #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.

This Medication Guide has been approved by the U.S. Nutrient and Drug Assistants.

From

Report Bug to the Food and Drug Assistants

You are encouraged to written report negative side furnishings of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

What Other Drugs Have The Same Makeup Of 12.5 Zolpidemb,

Source: https://www.rxlist.com/ambien-cr-drug.htm

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