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Zolpidem, sold under the brand name Ambien, among others, is a medication primarily used for the short-term treatment of sleeping problems. (Buy ambien online)

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WHAT IS AMBIEN® (ZOLPIDEM TARTRATE) OR AMBIEN CR® (ZOLPIDEM TARTRATE)

AMBIEN is a prescription medicine for the short-term treatment of adults who have trouble falling asleep.

AMBIEN CR is a prescription medicine for treatment of adults with trouble falling asleep and/or waking up often during the night.

AMBIEN and AMBIEN CR are not recommended in children under the age of 18 years.

IMPORTANT SAFETY INFORMATION

WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN or AMBIEN CR. Some of these events may result in serious injuries, including death. Discontinue AMBIEN or AMBIEN CR immediately if you experience a complex sleep behavior.

Do not take more AMBIEN or AMBIEN CR than prescribed.

Do not take AMBIEN or 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 or AMBIEN CR only once per night, right before going to bed.

AMBIEN and AMBIEN CR may cause serious side effects including complex sleep behaviors that have caused serious injury and death. After taking AMBIEN or AMBIEN CR you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with AMBIEN or AMBIEN CR whether or not you drink alcohol or take other medicines that make you sleepy.

  • Reported activities include:
    • driving a car (“sleep-driving”)
    • making and eating food
    • talking on the phone
    • having sex
    • sleep-walking
  • Stop taking AMBIEN or AMBIEN CR and call your doctor right away if you find out that you have done any of these activities after taking AMBIEN or AMBIEN CR.

You should not drive a car or do things that require clear thinking the day after you take AMBIEN CR.

Do not take AMBIEN or AMBIEN CR if you:

  • have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone, or having sex while not being fully awake) after taking AMBIEN or AMBIEN CR.
  • drank alcohol that evening or before bed.
  • take other medicines that can make you sleepy.

AMBIEN and AMBIEN CR are federally controlled substances (C-IV) because they can be abused or cause dependence.

Do not take AMBIEN or AMBIEN CR if you are allergic to zolpidem or any other ingredients in AMBIEN or AMBIEN CR.

  • Do not take AMBIEN or AMBIEN CR if you have had an allergic reaction to drugs containing zolpidem, such as AMBIEN CR, 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

Before taking AMBIEN or AMBIEN CR, tell your doctor about all of your medical conditions, including if you:

  • have a history of depression, mental illness, or suicidal thoughts
  • have a history of drug or alcohol abuse or addiction
  • have kidney or liver disease
  • have a lung disease or breathing problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed.
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AMBIEN and AMBIEN CR may cause serious side effects, including:

  • getting out of bed while not being fully awake and doing an activity that you do not know you are doing.
  • abnormal thoughts and behavior. For AMBIEN and AMBIEN CR, symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions and additionally for AMBIEN CR, acting strangely.
  • memory loss
  • anxiety
  • severe allergic reactions. Symptoms include swelling of the tongue or throat, and trouble breathing. Get emergency medical help if you get these symptoms after taking AMBIEN or AMBIEN CR.
  • 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 or AMBIEN CR.

The most common side effects of AMBIEN include drowsiness, dizziness, diarrhea, grogginess or feeling as if you have been drugged.

The most common side effects of AMBIEN CR include headache, sleepiness, dizziness and drowsiness the next day after you take AMBIEN CR.

Take AMBIEN CR tablets whole. Do not break, crush, dissolve or chew AMBIEN CR tablets before swallowing.

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

If you take too much AMBIEN or AMBIEN CR or overdose, get emergency treatment.

Click here for full Prescribing Information including boxed WARNING and Medication Guide for AMBIEN.

Click here for full Prescribing Information including boxed WARNING and Medication Guide for AMBIEN CR.

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Uses

Zolpidem is used to treat a certain sleep problem (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night’s rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect.

This medication is usually limited to short treatment periods of 1 to 2 weeks or less.

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How to use Ambien

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking zolpidem and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach as directed by your doctor, usually once a night. Since zolpidem works quickly, take it right before you get into bed. Do not take it with or after a meal because it will not work as quickly.

Do not take a dose of this drug unless you have time for a full night’s sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss and may have trouble safely doing any activity that requires alertness, such as driving or operating machinery. (See also Precautions section.)

Dosage is based on your gender, age, medical condition, other medications you may be taking, and response to treatment. Do not increase your dose, take it more often, or use it for longer than prescribed. Do not take more than 10 milligrams a day. Women are usually prescribed a lower dose because the drug is removed from the body more slowly than in men. Older adults are usually prescribed a lower dose to decrease the risk of side effects.

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If you suddenly stop using this medication, you may have withdrawal symptoms (such as nauseavomiting, flushing, stomach cramps, nervousness, shakiness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used zolpidem for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists after 7 to 10 days, or if it worsens.

You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after 1-2 nights. If this effect continues, contact your doctor.

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SIDE EFFECTS

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

  • Complex Sleep Behaviors [seeWARNINGS AND PRECAUTIONS]
  • CNS-Depressant Effects and Next-Day Impairment [see WARNINGS AND PRECAUTIONS]
  • Serious Anaphylactic and Anaphylactoid Reactions [seeWARNINGS AND PRECAUTIONS]
  • Abnormal Thinking and Behavior Changes [see WARNINGS AND PRECAUTIONS]
  • Withdrawal effects [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Associated With Discontinuation Of Treatment

Approximately 4% of 1,701 patients who received zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).

Approximately 4% of 1,959 patients who received zolpidem at all doses (1 to 50 mg) in similar foreign trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness (1.1%), dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and falls (0.4%).

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

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Most Commonly Observed Adverse Reactions In Controlled Trials

During short-term treatment (up to 10 nights) with AMBIEN at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were drowsiness (reported by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights) with zolpidem at doses up to 10 mg, the most commonly observed adverse reactions associated with the use of zolpidem and seen at statistically significant differences from placebo-treated patients were dizziness (5%) and drugged feelings (3%).

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Adverse Reactions Observed At An Incidence Of ≥1% In Controlled Trials

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

The following table was derived from results of 11 placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses ranging from 1.25 to 20 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use.

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Table 1: Incidences of Treatment-Emergent Adverse Reactions in Placebo-Controlled Clinical Trials Lasting up to 10 Nights (percentage of patients reporting)

 

Body System Adverse Reaction* Zolpidem (≤10 mg)
(N=685)
Placebo
(N=473)
Central and Peripheral Nervous System
Headache 7 6
Drowsiness 2
Dizziness 1
Gastrointestinal System
Diarrhea 1
* Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.

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The following table was derived from results of three placebo-controlled long-term efficacy trials involving AMBIEN (zolpidem tartrate). These trials involved patients with chronic insomnia who were treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The table is limited to data from doses up to and including 10 mg, the highest dose recommended for use. The table includes only adverse events occurring at an incidence of at least 1% for zolpidem patients.

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

 

Body System Adverse Event* Zolpidem (≤10 mg)
(N=152)
Placebo
(N=161)
Autonomic Nervous System
Dry mouth 3 1
Body as a Whole
Allergy 4 1
Back Pain 3 2
Influenza-like symptoms 2
Chest pain 1
Cardiovascular System
Palpitation 2
Central and Peripheral Nervous System
Drowsiness 8 5
Dizziness 5 1
Lethargy 3 1
Drugged feeling 3
Lightheadedness 2 1
Depression 2 1
Abnormal dreams 1
Amnesia 1
Sleep disorder 1
Gastrointestinal System
Diarrhea 3 2
Abdominal pain 2 2
Constipation 2 1
Respiratory System
Sinusitis 4 2
Pharyngitis 3 1
Skin and Appendages
Rash 2 1
* Reactions reported by at least 1% of patients treated with AMBIEN and at a greater frequency than placebo.

 

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Dose Relationship For Adverse Reactions

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

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Adverse Event Incidence Across The Entire Preapproval Database

AMBIEN was administered to 3,660 subjects in clinical trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse events associated with clinical trial participation were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.

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

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

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Autonomic nervous system: Infrequent: increased sweating, pallor, postural hypotensionsyncope. Rare: abnormal accommodation, altered saliva, flushing, glaucomahypotensionimpotence, increased saliva, tenesmus.

Body as a whole: Frequent: asthenia. Infrequent: edema, falling, fatigue, fever, malaisetrauma. Rare: allergic reaction, allergy aggravated, anaphylactic shock, face edema, hot flashes, increased ESR, pain, restless legs, rigors, tolerance increased, weight decrease.

Cardiovascular system: Infrequent: cerebrovascular disorder, hypertensiontachycardia. Rare: angina pectorisarrhythmia, arteritis, circulatory failure, extrasystoles, hypertension aggravated, myocardial infarctionphlebitispulmonary embolismpulmonary edema, varicose veins, ventricular tachycardia.

Central and peripheral nervous system: Frequent: ataxia, confusion, euphoria, headache, insomnia, vertigo. Infrequent: agitation, anxiety, decreased cognition, detached, difficulty concentrating, dysarthria, emotional labilityhallucination, hypoesthesia, illusion, leg cramps, migraine, nervousness, paresthesia, sleeping (after daytime dosing), speech disorder, stupor, tremor. Rare: abnormal gait, abnormal thinking, aggressive reaction, apathy, appetite increased, decreased libidodelusiondementia, depersonalization, dysphasia, feeling strange, hypokinesia, hypotonia, hysteria, intoxicated feeling, manic reaction, neuralgia, neuritis, neuropathyneurosis, panic attacks, paresispersonality disordersomnambulism, suicide attempts, tetanyyawning.

Gastrointestinal system: Frequent: dyspepsia, hiccup, nausea. Infrequent: anorexia, constipation, dysphagiaflatulencegastroenteritis, vomiting. Rare: enteritis, eructation, esophagospasm, gastritishemorrhoidsintestinal obstructionrectal hemorrhage, tooth caries.

Hematologic and lymphatic system: Rare: anemia, hyperhemoglobinemia, leukopenialymphadenopathymacrocytic anemia, purpurathrombosis.

Immunologic system: Infrequent: infection. Rare: abscess herpes simplex herpes zosterotitis externaotitis media.

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

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

Musculoskeletal system: Frequent: arthralgiamyalgia. Infrequent: arthritis. Rare: arthrosis, muscle weakness, sciaticatendinitis.

Reproductive system: Infrequent: menstrual disorder, vaginitis. Rare: breast fibroadenosis, breast neoplasmbreast pain. Respiratory system: Frequent: upper respiratory infection, lower respiratory infection. Infrequent: bronchitis, coughing, dyspnearhinitis. Rare: bronchospasm, respiratory depressionepistaxishypoxialaryngitispneumonia.

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, eye pain, scleritis, taste perversion, tinnitus. Rare: conjunctivitis, corneal ulcerationlacrimation abnormal, parosmia, photopsia.

Urogenital system: Frequent: urinary tract infection. Infrequent: cystitisurinary incontinence. Rare: acute renal failure, dysuriamicturition frequency, nocturiapolyuriapyelonephritis, renal pain, urinary retention.

Postmarketing Experience

The following adverse reactions have 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 estimate their frequency or establish a causal relationship to drug exposure.

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

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