How to Get Hallucinogenic Effects of Ambien Again

What is Ambien and how is it used?

Ambien is a prescription medicine used to treat the symptoms of insomnia. Ambien may be used lonely or with other medications.

Ambien belongs to a class of drugs called Sedative/Hypnotics, Indisposition.

It is not known if Ambien is condom and effective in children.

What are the possible side effects of Ambien?

Ambien may cause serious side effects including:

• anxiety,
• depression,
• aggression,
• agitation,
• confusion,
• hallucinations,
• memory problems,
• unusual thoughts or beliefs,
• thoughts of hurting yourself, and
• lightheadedness

Get medical help right away, if you have whatever of the symptoms listed above.

The most mutual side furnishings of Ambien include:

• daytime drowsiness,
• dizziness,
• feeling "drugged" or light-headed,
• headache,
• diarrhea, and
• feeling tired

Tell the doctor if you lot have whatsoever side outcome that bothers you or that does not go away.

These are not all the possible side effects of Ambien. For more than information, ask your doctor or pharmacist.

Call your doctor for medical communication about side effects. You lot may study side effects to FDA at i-800-FDA-1088.

DESCRIPTION

AMBIEN contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. AMBIEN is bachelor in 5 mg and ten mg strength tablets for oral assistants.

Chemically, zolpidem is North,Northward,six-trimethyl-2-p-tolylimidazo[one,two-a] pyridine-3-acetamide L-(+)-tartrate (2:i). It has the following construction:

Zolpidem tartrate is a white to fair crystalline powder that is sparingly soluble in h2o, booze, and propylene glycol. It has a molecular weight of 764.88.

Each AMBIEN tablet includes the post-obit inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The five mg tablet besides contains FD&C Red No. 40, atomic number 26 oxide colorant, and polysorbate 80.

INDICATIONS

AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized past difficulties with sleep initiation. AMBIEN has been shown to decrease slumber latency for upwards to 35 days in controlled clinical studies [see Clinical Studies].

The clinical trials performed in support of efficacy were 4-5 weeks in duration with the terminal formal assessments of sleep latency performed at the stop of treatment.

DOSAGE AND ADMINISTRATION

Dosage In Adults

Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either five or 10 mg for men, taken only once per night immediately before bedtime with at to the lowest degree seven-8 hours remaining earlier the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning claret levels following use of the x mg dose increase the risk of next-day damage of driving and other activities that require total alacrity [see WARNINGS AND PRECAUTIONS]. The total dose of AMBIEN should not exceed 10 mg one time daily immediately before bedtime. AMBIEN should be taken every bit a single dose and should not be readministered during the same nighttime.

The recommended initial doses for women and men are different considering zolpidem clearance is lower in women.

Special Populations

Elderly or devitalized patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of AMBIEN in these patients is 5 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].

Patients with balmy to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of AMBIEN in these patients is 5 mg in one case daily immediately before bedtime. Avert AMBIEN apply in patients with severe hepatic damage as it may contribute to encephalopathy [see WARNINGS AND PRECAUTIONS, Use In Specific Populations, CLINICAL PHARMACOLOGY].

Use With CNS Depressants

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

Administration

The issue of AMBIEN may exist slowed by ingestion with or immediately after a repast.

HOW SUPPLIED

Dosage Forms And Strengths

AMBIEN is available in five mg and 10 mg force tablets for oral administration. Tablets are not scored.

AMBIEN v mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other.

AMBIEN 10 mg tablets are sheathing-shaped, white, motion picture coated, with AMB 10 debossed on one side and 5421 on the other.

Storage And Handling

AMBIEN 5 mg tablets are capsule-shaped, pinkish, film coated, with AMB five debossed on one side and 5401 on the other and supplied as:

NDC Number	Size
0024-5401-31	bottle of 100

AMBIEN 10 mg tablets are capsule-shaped, white, picture show coated, with AMB 10 debossed on one side and 5421 on the other and supplied every bit:

NDC Number	Size
0024-5421-31	bottle of 100

Shop at controlled room temperature 20°C-25°C (68°F-77°F).

sanofi-aventis U.Due south. LLC Bridgewater, NJ 08807 A SANOFI Company. Revised: Aug 2019

SLIDESHOW

Sleep Disorders: Foods That Help Sleep or Keep You Awake See Slideshow

SIDE Furnishings

The post-obit serious agin reactions are discussed in greater detail in other sections of the labeling:

• Circuitous Slumber Behaviors [see WARNINGS AND PRECAUTIONS]
• CNS-Depressant Effects and Adjacent-Twenty-four hours Impairment [see WARNINGS AND PRECAUTIONS]
• Serious Anaphylactic and Anaphylactoid Reactions [see WARNINGS AND PRECAUTIONS]
• Abnormal Thinking and Behavior Changes [see WARNINGS AND PRECAUTIONS]
• Withdrawal effects [come across WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Associated With Discontinuation Of Handling

Approximately 4% of 1,701 patients who received zolpidem at all doses (ane.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an agin reaction. Reactions nigh commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.five%), dizziness (0.iv%), headache (0.5%), nausea (0.6%), and vomiting (0.v%).

Approximately 4% of i,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued handling because of an agin reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.ane%), dizziness/vertigo (0.8%), amnesia (0.v%), nausea (0.5%), headache (0.4%), and falls (0.4%).

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

Most Commonly Observed Adverse Reactions In Controlled Trials

During curt-term treatment (up to 10 nights) with AMBIEN at doses upwards to ten mg, the virtually unremarkably observed agin reactions associated with the utilize of zolpidem and seen at statistically pregnant differences from placebo-treated patients were drowsiness (reported by two% of zolpidem patients), dizziness (ane%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically pregnant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).

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

The post-obit tables enumerate treatment-emergent adverse reactions frequencies that were observed at an incidence equal to 1% or greater among patients with insomnia who received zolpidem tartrate and at a greater incidence than placebo in U.Due south. placebo-controlled trials. Events reported by investigators were classified utilizing a modified Earth Health Organization (WHO) dictionary of preferred terms for the purpose of establishing event frequencies. The prescriber should exist aware that these figures cannot be used to predict the incidence of side effects in the grade of usual medical practice, in which patient characteristics and other factors differ from those that prevailed in these clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials is conducted under a different set of weather. However, the cited figures provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side furnishings in the population studied.

The following table was derived from results of eleven placebo-controlled brusk-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to xx mg. The table is express to data from doses up to and including 10 mg, the highest dose recommended for use.

Tabular array i: Incidences of Treatment-Emergent Adverse Reactions in Placebo-Controlled Clinical Trials Lasting up to 10 Nights (percentage of patients reporting)

Trunk System Agin Reaction*	Zolpidem (≤x mg) (N=685)	Placebo (North=473)
Central and Peripheral Nervous System
Headache	seven	half-dozen
Drowsiness	2	-
Dizziness	i	-
Gastrointestinal System
Diarrhea	i	-
* Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.

The following table was derived from results of iii placebo-controlled long-term efficacy trials involving AMBIEN (zolpidem tartrate). These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of five, 10, or 15 mg. The table is limited to data from doses upward to and including 10 mg, the highest dose recommended for use. The table includes simply adverse events occurring at an incidence of at to the lowest degree i% for zolpidem patients.

Table 2: Incidence of Handling-Emergent Adverse Experiences in Placebo-Controlled Clinical Trials Lasting upward to 35 Nights (percentage of patients reporting)

Body System Adverse Consequence*	Zolpidem (≤10 mg) (N=152)	Placebo (N=161)
Autonomic Nervous Organization
Dry mouth	three	1
Body as a Whole
Allergy	4	1
Back Hurting	3	two
Influenza-similar symptoms	2	-
Chest pain	one	-
Cardiovascular System
Palpitation	2	-
Central and Peripheral Nervous Organization
Drowsiness	eight	five
Dizziness	5	ane
Lethargy	3	1
Drugged feeling	3	-
Lightheadedness	2	1
Low	two	ane
Abnormal dreams	one	-
Amnesia	ane	-
Sleep disorder	one	-
Gastrointestinal Organization
Diarrhea	3	2
Abdominal pain	2	2
Constipation	2	1
Respiratory Arrangement
Sinusitis	4	ii
Pharyngitis	3	ane
Skin and Appendages
Rash	2	i
* Reactions reported past at least one% of patients treated with AMBIEN and at a greater frequency than placebo.

Dose Human relationship For Adverse Reactions

In that location is show from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem employ, especially for sure CNS and gastrointestinal adverse events.

Adverse Event Incidence Across The Unabridged Preapproval Database

AMBIEN was administered to iii,660 subjects in clinical trials throughout the U.Due south., Canada, and Europe. Handling-emergent adverse events associated with clinical trial participation were recorded past clinical investigators using terminology of their own choosing. To provide a meaningful judge of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized upshot categories and classified utilizing a modified World Health System (WHO) dictionary of preferred terms.

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

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

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

Body every bit a whole: Frequent: asthenia. Infrequent: edema, falling, fatigue, fever, malaise, trauma. Rare: allergic reaction, allergy aggravated, anaphylactic daze, confront edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease.

Cardiovascular arrangement: 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.

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

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

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

Immunologic arrangement: Exceptional: infection. Rare: abscess herpes simplex herpes zoster, otitis externa, otitis media.

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

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

Musculoskeletal organisation: Frequent: arthralgia, myalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciatica, tendinitis.

Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasm, chest pain. Respiratory system: Frequent: upper respiratory infection, lower respiratory infection. Infrequent: bronchitis, cough, dyspnea, rhinitis. 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. Infrequent: eye irritation, centre pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulceration, lacrimation abnormal, parosmia, photopsia.

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

Postmarketing Experience

The following adverse reactions accept been identified during postapproval use of AMBIEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably gauge their frequency or constitute a causal relationship to drug exposure.

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

DRUG INTERACTIONS

CNS-Active Drugs

CNS Depressants

Coadministration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant utilise of zolpidem with these drugs may increase drowsiness and psychomotor damage, including impaired driving power [see WARNINGS AND PRECAUTIONS].

Zolpidem tartrate was evaluated in healthy volunteers in single-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, merely there was an additive upshot of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but at that place was an additive event of decreased alertness and psychomotor functioning [come across CLINICAL PHARMACOLOGY].

Haloperidol

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

Alcohol

An condiment adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [run across WARNINGS AND PRECAUTIONS].

Sertraline

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

Drugs That Affect Drug Metabolism Via Cytochrome P450

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

CYP3A4 Inducers

Rifampin

Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem. Utilize of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem and is not recommended [run across CLINICAL PHARMACOLOGY].

St. John'due south Wort

Use of St. John's wort, a CYP3A4 inducer, in combination with zolpidem may subtract blood levels of zolpidem and is not recommended.

CYP3A4 Inhibitors

Ketoconazole

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

Drug Abuse And Dependence

Controlled Substance

Zolpidem tartrate is classified every bit a Schedule Four controlled substance by federal regulation.

Corruption

Corruption and addiction are separate and distinct from concrete dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, frequently in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that consequence in a diminution of i or more than 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.

Habit is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. Information technology is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and peckish. Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common.

Studies of abuse potential in erstwhile drug abusers found that the furnishings of unmarried doses of zolpidem tartrate 40 mg were like, only not identical, to diazepam twenty mg, while zolpidem tartrate 10 mg was 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 carefully when receiving zolpidem or whatever other hypnotic.

Dependence

Concrete dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by sharp 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 intestinal and muscle cramps, vomiting, sweating, tremors, and convulsions. The post-obit adverse events, which are considered to meet the DSMIII-R criteria for uncomplicated sedative/hypnotic withdrawal, were reported during U.S. clinical trials following placebo exchange occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness, and intestinal discomfort. These reported agin events occurred at an incidence of 1% or less. However, bachelor data cannot provide a reliable estimate of the incidence, if whatever, of dependence during treatment at recommended doses. Postmarketing reports of corruption, dependence and withdrawal have been received.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Complex Sleep Behaviors

Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur post-obit the kickoff or whatever subsequent employ of AMBIEN. Patients can be seriously injured or injure others during complex sleep behaviors . Such injuries may consequence in a fatal event. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sexual activity) accept as well been reported. Patients usually exercise non remember these events. Postmarketing reports have shown that circuitous sleep behaviors may occur with AMBIEN alone at recommended doses, with or without the concomitant use of alcohol or other Central Nervous System (CNS) depressants [see DRUG INTERACTIONS]. Discontinue AMBIEN immediately if a patient experiences a complex sleep beliefs [see CONTRAINDICATIONS].

CNS-Depressant Furnishings And Side by side-Day Harm

AMBIEN, like other sedative-hypnotic drugs, has CNS-depressant effects. Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression [come across DRUG INTERACTIONS]. Dosage adjustments of AMBIEN and of other concomitant CNS depressants may be necessary when AMBIEN is administered with such agents because of the potentially additive effects. The utilize of AMBIEN with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see DOSAGE AND ADMINISTRATION].

The chance of next-day psychomotor impairment, including impaired driving, is increased if AMBIEN is taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase the claret levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alertness if AMBIEN is taken in these circumstances [run into DOSAGE AND Assistants, Clinical Studies].

Vehicle drivers and automobile 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 dumb driving the morning after therapy. In guild to minimize this chance a full night of sleep (7-eight hours) is recommended.

Because AMBIEN can crusade drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.

Need To Evaluate For Comorbid Diagnoses

Because slumber 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 afterward 7 to ten days of treatment may indicate the presence of a main psychiatric and/or medical disease 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 form of treatment with allaying/hypnotic drugs, including zolpidem.

Severe Anaphylactic And Anaphylactoid Reactions

Cases of angioedema involving the tongue, glottis or larynx accept been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had boosted symptoms such as dyspnea, pharynx closing or nausea and vomiting that suggest anaphylaxis. Some patients accept 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 Behavioral Changes

Abnormal thinking and behavior changes accept been reported in patients treated with sedative/hypnotics, including AMBIEN. Some of these changes included decreased inhibition (east.thou., aggressiveness and extroversion that seemed out of character), bizarre beliefs, agitation and depersonalization. Visual and auditory hallucinations take been reported.

In controlled trials of AMBIEN x mg taken at bedtime <1% of adults with insomnia reported hallucinations. In a clinical trial, seven% of pediatric patients treated with AMBIEN 0.25 mg/kg taken at bedtime reported hallucinations versus 0% treated with placebo [come across Use In Specific Populations].

It can rarely be determined with certainty whether a detail 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 whatever new behavioral sign or symptom of business requires careful and firsthand evaluation.

Use In Patients With Depression

In primarily depressed patients treated with allaying-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 mutual in this group of patients; therefore, the everyman number of tablets that is viable should exist prescribed for the patient at whatsoever one fourth dimension.

Respiratory Depression

Although studies with x mg zolpidem tartrate did not reveal respiratory depressant effects at hypnotic doses in healthy subjects or in patients with balmy to moderate chronic obstructive pulmonary affliction (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 eighty% and 90%, was observed in patients with mild to moderate sleep apnea when treated with zolpidem compared to placebo. Since sedative-hypnotics take the capacity to depress respiratory drive, precautions should exist taken if AMBIEN is prescribed to patients with compromised respiratory office. Postmarketing reports of respiratory insufficiency in patients receiving x mg of zolpidem tartrate, well-nigh of whom had pre-existing respiratory impairment, take been reported. The risk of respiratory depression should be considered prior to prescribing AMBIEN in patients with respiratory harm including sleep apnea and myasthenia gravis.

Atmospheric precipitation Of Hepatic Encephalopathy

Drugs affecting GABA receptors, such as zolpidem tartrate, take been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency. In addition, patients with hepatic insufficiency practise not articulate zolpidem tartrate equally speedily as patients with normal hepatic role. Avert AMBIEN utilize in patients with severe hepatic impairment equally it may contribute to encephalopathy [see DOSAGE AND Assistants, Apply In Specific Populations, CLINICAL PHARMACOLOGY].

Withdrawal Effects

There have been reports of withdrawal signs and symptoms following the rapid dose subtract or abrupt discontinuation of zolpidem. Monitor patients for tolerance, corruption, and dependence [encounter Drug Abuse And Dependence].

Patient Counseling Information

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. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with AMBIEN and with each prescription refill. Review the AMBIEN Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that AMBIEN should be taken only equally prescribed.

Complex Sleep Behaviors

Instruct patients and their families that AMBIEN may crusade circuitous sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death accept occurred during circuitous sleep behavior episodes. Tell patients to discontinue AMBIEN and notify their healthcare provider immediately if they develop whatsoever of these symptoms [run across BOXED Warning, WARNINGS AND PRECAUTIONS].

CNS-Depressant Effects And Next-Day Impairment

Tell patients that AMBIEN has the potential to cause adjacent-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see WARNINGS AND PRECAUTIONS].

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 suggest patients to seek medical attention immediately if any of them occur [see WARNINGS AND PRECAUTIONS].

Suicide

Tell patients to immediately report whatever suicidal thoughts.

Booze And Other Drugs

Inquire patients well-nigh alcohol consumption, medicines they are taking, and drugs they may exist taking without a prescription. Advise patients not to utilize AMBIEN if they drank alcohol that evening or before bed.

Tolerance, Abuse, And Dependence

Tell patients non to increment the dose of AMBIEN on their own, and to inform you lot if they believe the drug "does not piece of work."

Administration Instructions

Patients should be counseled to accept AMBIEN right before they get into bed and only when they are able to stay in bed a full nighttime (7-8 hours) before being active again. AMBIEN tablets should not exist taken with or immediately after a repast. Suggest patients Non to take AMBIEN if they drank alcohol that evening.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with AMBIEN. Propose patients that use of AMBIEN late in the third trimester may cause respiratory low and sedation in neonates. Advise mothers who used AMBIEN during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness [run across Apply In Specific Populations].

Lactation

Advise breastfeeding mothers using AMBIEN to monitor infants for increased sleepiness, animate difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical care if they observe these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after AMBIEN assistants to minimize drug exposure to a breastfed baby [see Utilise In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Harm Of Fertility

Carcinogenesis

Zolpidem was administered to mice and rats for 2 years at oral doses of iv, xviii, and 80 mg base/kg/24-hour interval. In mice, these doses are approximately 2.5, 10, and 50 times the MRHD of 10 mg/day (viii mg zolpidem base) based on mg/m² body surface expanse and in rats, these doses are approximately 5, 20, and 100 times the MRHD based on mg/m² body expanse. No prove 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.

Impairment Of Fertility

Zolpidem was administered to rats at 4, 20, and 100 mg base/kg/mean solar day, which are approximately five, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/g² trunk surface area, prior to and during mating, and continuing in females through postpartum twenty-four hour period 25. Zolpidem acquired irregular estrus cycles and prolonged precoital intervals at the highest dose tested, which is approximately 120 times the MRHD based on mg/m² trunk expanse. The NOAEL for these effects is 25 times the MRHD based on a mg/thousand² torso expanse. There was no impairment of fertility at any dose tested.

Utilise In Specific Populations

Pregnancy

Risk Summary

Neonates built-in to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory low and sedation [run into Clinical Considerations and Data]. Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see Data]. Oral administration of zolpidem to pregnant rats and rabbits did non indicate a hazard for adverse effects on fetal development at clinically relevant doses [come across Information].

The estimated background hazard of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a groundwork risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major nascence defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Clinical Considerations

Fetal/Neonatal Agin Reactions

Zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. Monitor neonates exposed to AMBIEN during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly.

Information

Human Information

Published data from observational studies, birth registries, and case reports on the use of zolpidem during pregnancy practise non report a articulate association with zolpidem and major birth defects.

At that place are limited postmarketing reports of astringent to moderate cases of respiratory low that occurred afterward birth in neonates whose mothers had taken zolpidem during pregnancy. These cases required artificial ventilation or intratracheal intubation. The majority of neonates recovered within hours to a few weeks after birth once treated.

Zolpidem has been shown to cantankerous the placenta.

Animal Data

Oral administration of zolpidem to significant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the maximum recommended homo dose (MRHD) of 10 mg/day (8 mg zolpidem base) based on mg/m² torso surface surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times the MRHD based on mg/m² body surface area.

Oral assistants of zolpidem to significant rabbits during the period of organogenesis at i, 4, and xvi mg base/kg/day, which are approximately 2.five, 10, and 40 times the MRHD of 10 mg/twenty-four hours (8 mg zolpidem base) based on mg/g² trunk surface area caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times the MRHD based on mg/m² trunk expanse.

Oral assistants of zolpidem to pregnant rats from day fifteen of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (eight mg zolpidem base) based on mg/grand² body area, delayed offspring growth and decreased survival at doses 25 and 120 times, respectively, the MRHD based on mg/m² body surface area.

Lactation

Hazard Summary

Express data from published literature report the presence of zolpidem in human milk. In that location are reports of backlog sedation in infants exposed to zolpidem through breastmilk [encounter Clinical Considerations]. There is no information on the effects of zolpidem on milk production. The developmental and wellness benefits of breastfeeding should be considered along with the mother’s clinical demand for AMBIEN and any potential adverse furnishings on the breastfed infant from AMBIEN or from the underlying maternal condition.

Clinical Considerations

Infants exposed to AMBIEN through breastmilk should be monitored for excess sedation, hypotonia, and respiratory depression. A lactating woman may consider interrupting breastfeeding and pumping and discarding chest milk during handling and for 23 hours (approximately v elimination half-lives) after AMBIEN assistants in lodge to minimize drug exposure to a breast fed infant.

Pediatric Use

AMBIEN is not recommended for employ in children. Prophylactic and effectiveness of zolpidem in pediatric patients below the age of eighteen years have non been established.

In an 8-calendar week report in pediatric patients (aged 6-17 years) with insomnia associated with attending-deficit/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 arrangement disorders comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.v% vs i.five%), headache (12.5% vs 9.ii%), 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]. Ten patients on zolpidem (7.4%) discontinued treatment due to an agin reaction.

Geriatric Apply

A total of 154 patients in U.Southward. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were ≥threescore years of age. For a pool of U.South. patients receiving zolpidem at doses of ≤x mg or placebo, in that location were three adverse reactions occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could exist considered drug related).

Adverse Consequence	Zolpidem	Placebo
Dizziness	three%	0%
Drowsiness	5%	2%
Diarrhea	iii%	ane%

A total of 30/ane,959 (1.five%) non-U.South. patients receiving zolpidem reported falls, including 28/30 (93%) who were ≥lxx years of historic period. Of these 28 patients, 23 (82%) were receiving zolpidem doses >x mg. A total of 24/1,959 (1.2%) not-U.Due south. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg.

The dose of AMBIEN in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see WARNINGS AND PRECAUTIONS].

Gender Difference In Pharmacokinetics

Women clear zolpidem tartrate from the torso at a lower rate than men. Cmax and AUC parameters of zolpidem were approximately 45% higher at the aforementioned dose in female subjects compared with male subjects. Given the college claret levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of AMBIEN for adult women is v mg, and the recommended dose for developed men is 5 or 10 mg.

In geriatric patients, clearance of zolpidem is similar in men and women. The recommended dose of AMBIEN in geriatric patients is 5 mg regardless of gender.

Hepatic Impairment

The recommended dose of AMBIEN in patients with balmy to moderate hepatic impairment is 5 mg one time daily immediately before bedtime. Avoid AMBIEN utilize in patients with severe hepatic impairment as it may contribute to encephalopathy [encounter DOSAGE AND Assistants, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

Overdosage & Contraindications

OVERDOSE

Signs And Symptoms

In postmarketing feel 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.

Recommended Treatment

Full general symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should exist administered as needed. Zolpidem’s sedative hypnotic effect was shown to exist reduced by flumazenil and therefore may exist 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 full general supportive measures employed. Hypotension and CNS depression should exist monitored and treated by advisable medical intervention. Sedating drugs should be withheld post-obit zolpidem overdosage, even if excitation occurs. The value of dialysis in the handling 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 exist considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug production overdosage.

CONTRAINDICATIONS

AMBIEN is contraindicated in patients

• who accept experienced complex sleep behaviors later on taking AMBIEN [see WARNINGS AND PRECAUTIONS.]
• with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [encounter WARNINGS AND PRECAUTIONS].

CLINICAL PHARMACOLOGY

Mechanism Of Action

Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the brusque-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

Pharmacodynamics

Zolpidem binds to GABA A receptors with greater affinity for α1 subunit relative to α2 and α3 subunit containing receptors. Zolpidem has no appreciable binding affinity for α5 subunit containing GABA A receptors. This binding contour may explain the relative absence of myorelaxant effects in animate being studies. Zolpidem has no appreciable binding analogousness for dopaminergic D2, serotonergic 5HT2, adrenergic, histaminergic or muscarinic receptors.

Pharmacokinetics

The pharmacokinetic profile of AMBIEN is characterized by rapid absorption from the gastrointestinal tract and a brusk elimination one-half-life (T½) in healthy subjects.

In a single-dose crossover study in 45 healthy subjects administered v and 10 mg zolpidem tartrate tablets, the mean peak concentrations (Cmax) were 59 (range: 29 to 113) and 121 (range: 58 to 272) ng/mL, respectively, occurring at a hateful time (Tmax) of 1.6 hours for both. The mean AMBIEN elimination half-life was 2.6 (range: 1.4 to iv.five) and 2.five (range: 1.iv to 3.8) hours, for the 5 and 10 mg tablets, respectively. AMBIEN is converted to inactive metabolites that are eliminated primarily by renal excretion. AMBIEN demonstrated linear kinetics in the dose range of 5 to 20 mg. Total protein binding was establish to be 92.5 ± 0.ane% and remained constant, contained of concentration between 40 and 790 ng/mL. Zolpidem did non accumulate in immature adults following nightly dosing with 20 mg zolpidem tartrate tablets for 2 weeks.

A food-effect study in 30 salubrious male person subjects compared the pharmacokinetics of AMBIEN x mg when administered while fasting or 20 minutes subsequently a meal. Results demonstrated that with food, hateful AUC and Cmax were decreased past 15% and 25%, respectively, while hateful Tmax was prolonged by 60% (from 1.4 to 2.two hr). The half-life remained unchanged. These results suggest that, for faster sleep onset, AMBIEN should not exist administered with or immediately after a meal.

Special Populations

Elderly

In the elderly, the dose for AMBIEN should be 5 mg [see WARNINGS AND PRECAUTIONS, DOSAGE AND ADMINISTRATION]. This recommendation is based on several studies in which the mean Cmax, T½, and AUC were significantly increased when compared to results in immature adults. In one study of 8 elderly subjects (>lxx years), the means for Cmax, T½, and AUC significantly increased by 50% (255 vs 384 ng/mL), 32% (2.ii vs two.9 hour), and 64% (955 vs 1,562 ng·60 minutes/mL), respectively, as compared to younger adults (20 to 40 years) post-obit a single 20 mg oral dose. AMBIEN did non accumulate in elderly subjects following nightly oral dosing of 10 mg for i week.

Hepatic Damage

The pharmacokinetics of AMBIEN in eight patients with chronic hepatic insufficiency was compared to results in healthy subjects. Following a single 20 mg oral zolpidem tartrate dose, mean Cmax and AUC were found to exist two times (250 vs 499 ng/mL) and 5 times (788 vs 4,203 ng·hr/mL) higher, respectively, in hepatically compromised patients. Tmax did not change. The mean half-life in cirrhotic patients of nine.9 60 minutes (range: 4.1 to 25.eight 60 minutes) was greater than that observed in normal subjects of 2.2 hour (range: one.6 to 2.4 hr) [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS, Use In Specific Populations].

Renal Impairment

The pharmacokinetics of zolpidem tartrate was studied in 11 patients with end-stage renal failure (mean ClCr = vi.5 ± 1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem tartrate 10 mg orally each day for xiv 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 fabricated. Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared afterward fourteen or 21 days. Zolpidem pharmacokinetics was not significantly unlike in renally impaired patients. No dosage adjustment is necessary in patients with compromised renal function.

Drug Interactions

CNS Depressants

Coadministration of zolpidem with other CNS depressants increases the take chances 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 peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, only in that location was an additive effect of decreased alertness and psychomotor performance.

A study involving haloperidol and zolpidem revealed no effect 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 effect post-obit chronic assistants.

An condiment agin effect on psychomotor performance betwixt booze 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 50 mg (17 consecutive daily doses, at vii:00 am, in good for you female volunteers), zolpidem Cmax was significantly college (43%) and Tmax was significantly decreased (-53%). Pharmacokinetics of sertraline and North-desmethylsertraline were unaffected by zolpidem.

A single-dose interaction study with zolpidem tartrate ten mg and fluoxetine 20 mg at steady-state levels in male person volunteers did non demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of zolpidem and fluoxetine were given at steady land and the concentrations evaluated in healthy females, an increment in the zolpidem one-half-life (17%) was observed. There was no evidence of an additive effect 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-land levels in male person volunteers resulted in a 34% increase in AUC0-∞ of zolpidem tartrate. There were no pharmacodynamic effects of zolpidem detected on subjective drowsiness, postural sway, or psychomotor performance.

A single-dose interaction study with zolpidem tartrate x mg and rifampin 600 mg at steady-country 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 furnishings of zolpidem tartrate. Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic furnishings of zolpidem [meet DRUG INTERACTIONS].

Similarly, St. John’s wort, a CYP3A4 inducer, may too decrease the blood levels of zolpidem.

A unmarried-dose interaction study with zolpidem tartrate v mg and ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased Cmax of zolpidem (30%) and the total AUC of zolpidem (70%) compared to zolpidem alone and prolonged the emptying one-half-life (30 %) forth with an increment in the pharmacodynamic furnishings 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’south 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 upshot of either drug on the pharmacokinetics or pharmacodynamics of zolpidem.

Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects.

Clinical Studies

Transient Indisposition

Normal adults experiencing transient insomnia (n=462) during the first dark in a slumber laboratory were evaluated in a double-blind, parallel group, single-nighttime trial comparison 2 doses of zolpidem (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep elapsing, and number of awakenings.

Normal elderly adults (mean age 68) experiencing transient indisposition (northward=35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, two-night trial comparison four doses of zolpidem (v, 10, xv and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality).

Chronic Insomnia

Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as divers in the APA Diagnostic and Statistical Transmission of Mental Disorders, DSM-4™). Adult outpatients with chronic insomnia (n=75) were evaluated in a double-bullheaded, parallel group, v-week trial comparing two doses of zolpidem tartrate and placebo. On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 10 mg was superior to placebo on sleep latency for the commencement 4 weeks and on sleep efficiency for weeks 2 and 4. Zolpidem was comparable to placebo on number of awakenings at both doses studied.

Adult outpatients (northward=141) with chronic insomnia were also evaluated, in a double-bullheaded, parallel group, 4-week trial comparing two doses of zolpidem and placebo. Zolpidem ten mg was superior to placebo on a subjective measure of sleep latency for all four weeks, and on subjective measures of full sleep fourth dimension, number of awakenings, and slumber quality for the showtime treatment week.

Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with AMBIEN.

Studies Pertinent To Safe Concerns For Sedative/Hypnotic Drugs

Next-Day Remainder Effects

Next-twenty-four hours residual effects of AMBIEN were evaluated in vii studies involving normal subjects. In three studies in adults (including 1 study in a phase accelerate model of transient insomnia) and in ane study in elderly subjects, a pocket-sized but statistically significant decrease in performance was observed in the Digit Symbol Exchange Test (DSST) when compared to placebo. Studies of AMBIEN in non-elderly patients with insomnia did not detect bear witness of next-24-hour interval residual furnishings using the DSST, the Multiple Sleep Latency Exam (MSLT), and patient ratings of alertness.

Rebound Furnishings

In that location was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of AMBIEN (zolpidem tartrate). There was subjective testify of dumb sleep in the elderly on the commencement post-handling night at doses above the recommended elderly dose of 5 mg.

Memory Harm

Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-24-hour interval retentivity impairment following the assistants of AMBIEN. Nonetheless, in one written report involving zolpidem doses of 10 and 20 mg, there was a significant subtract in next-morning recall of information presented to subjects during peak drug effect (ninety minutes mail dose), i.due east., these subjects experienced anterograde amnesia. There was also subjective show from agin event data for anterograde amnesia occurring in association with the administration of AMBIEN, predominantly at doses above 10 mg.

Effects On Sleep Stages

In studies that measured the percent of sleep fourth dimension spent in each sleep stage, AMBIEN has generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with merely inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.

PATIENT INFORMATION

AMBIEN ®
(zolpidem tartrate) tablets

Read the Medication Guide that comes with AMBIEN before you outset taking information technology and each time y'all go a refill. At that place may be new information. This Medication Guide does not have the place of talking to your healthcare provider about your medical status or treatment.

What is the most important data I should know almost AMBIEN?

• Do not have more AMBIEN than prescribed.
• Practice non accept AMBIEN unless you are able to stay in bed a total dark (7 to 8 hours) beforeyou must be active again.
• Have AMBIEN right earlier y'all arrive bed, not sooner.

AMBIEN may cause serious side effects,including:

• complex sleep behaviors that have causedserious injury and death. After taking AMBIEN, you may get up out of bed while not being fully awake and practice an activeness that you do not know you are doing (complex sleep behaviors). The next morn, y'all may not remember that you did anything during the night. These activities may occur with AMBIEN whether or not y'all drink alcohol or accept other medicines that make y'all sleepy. Reported activities include:
  • driving a automobile ("sleep-driving")
  • making and eating food
  • talking on the phone
  • having sexual practice
  • sleep-walking

Stop taking AMBIEN and call your healthcare provider right away if yous find out that you have done any of the above activities after takingAMBIEN.

Do non take AMBIEN if you:

• have ever experienced a complex sleep beliefs (such as driving a auto, making and eating food, talking on the telephone, or having sex while not being fully awake) afterward taking AMBIEN.
• drank alcohol that evening or before bed
• took another medicine to help you sleep

What is AMBIEN?

AMBIEN is a sedative-hypnotic (sleep) medicine. AMBIEN is used in adults for the short-term handling of a slumber trouble called indisposition (trouble falling asleep).

AMBIEN is not recommended for use in children under the historic period of 18 years.

AMBIEN is a federally controlled substance (C-Iv) considering information technology can be driveling or lead to dependence. Keep AMBIEN in a rubber identify to prevent misuse and abuse. Selling or giving away AMBIEN may impairment others, and is against the law. Tell your healthcare provider if you accept ever abused or accept been dependent on booze, prescription medicines or street drugs.

Who should not have AMBIEN?

• Do not take AMBIEN if you lot are allergic to zolpidem or whatever other ingredients in AMBIEN. Run across the end of this Medication Guide for a complete list of ingredients in AMBIEN.
• Practice not have AMBIEN if you have had an allergic reaction to drugs containing zolpidem, such every bit Ambien CR, Edluar, Zolpimist, or Intermezzo.
  Symptoms of a serious allergic reaction to zolpidem tin can include:
  • swelling of your face, lips, and pharynx that may cause difficulty breathing or swallowing

What should I tell my healthcare provider before taking AMBIEN?

AMBIEN may not exist right for you. Beforestarting AMBIEN, tell your healthcare provider about all of your health conditions, including if you lot:

• take a history of low, mental affliction, or suicidal thoughts
• accept a history of drug or alcohol abuse or habit
• have kidney or liver affliction
• have a lung disease or breathing issues
• are pregnant, planning to become significant. Talk to your healthcare provider nigh the take a chance to your unborn baby if you take AMBIEN.
• Using AMBIEN in the last trimester of pregnancy may cause breathing difficulties or excess sleepiness in your newborn. Monitor for signs of sleepiness (more than usual), trouble breathing, or limpness in the newborn if AMBIEN is taken late in pregnancy.
• are breastfeeding or programme to breastfeed. AMBIEN passes into your breast milk. Talk to your healthcare provider about the best way to feed your babe while you take AMBIEN.

Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

Medicines can collaborate with each other, sometimes causing serious side effects. Practice not take AMBIEN with other medicines that can brand y'all sleepyunless your healthcare provider tells you to.

Know the medicines you take. Keep a list of your medicines with you to testify your healthcare provider and pharmacist each time you get a new medicine.

How should I take AMBIEN?

• Run into "What is the most important information I should know about AMBIEN?"
• Take AMBIEN exactly as prescribed. Only take 1 AMBIEN tablet a nighttime if needed.
• Do non take AMBIEN if you drank alcohol that evening or before bed.
• Y'all should non take AMBIEN with or correct after a repast. AMBIEN may assistance you lot autumn comatose faster if you take it on an empty stomach.
• Call your healthcare provider if your insomnia worsens or is non better within 7 to 10 days. This may mean that there is another status causing your sleep problem.
• If you lot take too much AMBIEN or overdose, get emergency treatment.

What are the possible side furnishings of AMBIEN?AMBIEN may cause serious side effects, including:

• getting out of bed while non being fully awake and do an activity that you practice not know yous are doing. Come across "What is the most important data I should know well-nigh AMBIEN?"
• aberrant thoughts and behavior. Symptoms include more than outgoing or aggressive behavior than normal, defoliation, agitation,
• hallucinations, worsening of depression,
• and suicidal thoughts or actions.
• memory loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, and trouble breathing. Get emergency medical help if you lot get these symptoms afterward taking AMBIEN.

Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using AMBIEN.

The most common side effects of AMBIEN are:

• drowsiness
• dizziness
• diarrhea
• grogginess or feeling equally if you have been drugged

After you cease taking sleep medicine, y'all may have symptoms for 1 to two days such as:

• trouble sleeping
• nausea
• flushing
• lightheadedness
• uncontrolled crying
• vomiting
• tummy cramps
• panic attack
• nervousness
• stomach-area pain

These are not all the side effects of AMBIEN. Ask your healthcare provider or pharmacist for more data.

Telephone call your doc for medical advice about side furnishings. You may report side effects to FDA at one 800 FDA 1088.

How should I store AMBIEN?

• Store AMBIEN at room temperature, 68°F to 77°F (20°C to 25°C).

Proceed AMBIEN and all medicines out of reach of children.

General Information well-nigh the condom and effective use of AMBIEN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Practise not use AMBIEN for a condition for which information technology was not prescribed. Do not share AMBIEN with other people, even if they have the same symptoms that yous take. Information technology may harm them and information technology is against the constabulary.

This Medication Guide summarizes the most important data about AMBIEN. If you would like more information, talk with your healthcare provider. Yous tin ask your healthcare provider or pharmacist for information almost AMBIEN that is written for healthcare professionals.

For more information, call 1-800-633-1610.

What are the ingredients in AMBIEN?

Active Ingredient: Zolpidem tartrate

Inactive Ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the v mg tablet contains FD&C Red No. twoscore, iron oxide colorant, and polysorbate 80.

This Medication Guide has been approved by the U.Due south. Food and Drug Administration.

From

Report Problems to the Food and Drug Assistants

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

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

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