Author: Alex Thompson

Zolpidem: Side Effects, Dosage, Uses, and More

This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. Your doctor may start you on a lowered dosage or a different treatment schedule. This can help keep levels of this drug from building up too much in your body. Depression is a serious condition that can cause a lack of sleep. In some people, insomnia occurs before symptoms of depression.

Have you recently lost a loved one, had a job change, or had a marital dispute? All of these can affect your ability to rest soundly. While research has shown that some people are indeed prone to occasional parasomnias after taking Ambien, these are more of a physical rather than a cognitive nature. Some celebrities have tried to blame Ambien for their bilious comments or statements; a notable example being Roseanne Barr’s inflammatory comments about Valerie Jarrett, a former senior adviser to former President, Barack Obama. As the manufacturers of Ambien succinctly put it, “Racism is not a known side effect of any Sanofi medication”. Zolpidem (Ambien) is broken down (metabolized) in the liver to an inactive form, but the liver enzymes responsible for this process are more active in men than in women.

Drug information

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.

Tell your doctor if you are pregnant or plan to become pregnant before using Ambien; it is unknown how it will affect a fetus. Ambien passes into breast milk and may have adverse effects on a nursing baby. Ambien can cause withdrawal symptoms (muscle cramps, sweats, shaking, and seizures). Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row.

It is important to emphasize that,although the events reported did occur during treatment with AMBIEN, they werenot necessarily caused by it. Impairment with Ambien CR is increased with higher dosages; when taking it late at night with less than 7 to 8 hours of sleep left; in women; and if taken with narcotic pain medicines, antidepressants, or alcohol. If you still feel drowsy the next day after taking Ambien CR, talk to your doctor about reducing the dosage or alternative sleep medications. Do not attempt to do anything that requires alertness if you are not fully awake after taking Ambien CR. 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.

Because these reactions are reportedvoluntarily from a population of uncertain size, it is not always possible toreliably estimate their frequency or establish a causal relationship to drugexposure. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ambien only for the indication prescribed. Using Ambien with other drugs that make you drowsy can worsen this effect.

Abuse and addiction are separate and distinct fromphysical dependence and tolerance. Abuse is characterized by misuse of the drugfor non-medical purposes, often in combination with other psychoactivesubstances. Tolerance is a state of adaptation in which exposure to a drug induceschanges that result in a diminution of one or more of the drug effects overtime. Tolerance may occur to both desired and undesired effects of drugs andmay develop at different rates for different effects. Extended treatment should not take place without re-evaluation of the patient’s status because the risk of abuse and dependence increases with the duration of treatment [see Drug Abuse And Dependence]. Insomnia causes trouble falling asleep or staying asleep.

Warnings for people with certain health conditions

These results suggest that, for faster sleep onset, AMBIEN should not be administered with or immediately after a meal. Patients should be counseled to take AMBIEN right beforethey get into bed and only when they are able to stay in bed a full night (7-8hours) before being active again. AMBIEN tablets should not be taken with orimmediately after a meal.

1. This medication may also increase the risk of falls.
2. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.
3. Such findings have emerged during the course of treatment withsedative/hypnotic drugs, including zolpidem.
4. There are reports of excess sedation ininfants exposed to zolpidem through breastmilk [see Clinical Considerations].There is no information on the effects of zolpidem on milk production.

Theuse 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]. Events reported byinvestigators were classified utilizing a modified World Health Organization(WHO) dictionary of preferred terms for the purpose of establishing eventfrequencies. Similarly, the cited frequenciescannot be compared with figures obtained from other clinical investigatorsinvolving related drug products and uses, since each group of drug trials isconducted under a different set of conditions. However, the cited figuresprovide the physician with a basis for estimating the relative contribution ofdrug and nondrug factors to the incidence of side effects in the populationstudied. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.

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Any decision regarding the proper dose should be discussed with your prescribing physician and consideration of your entire list of medications should occur. You are encouraged to report negative side effects of prescription drugs to the FDA. Read the Medication Guide that comes with AMBIEN before you start taking it and each time you get a refill. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. A study involving cimetidine/zolpidem tartrate and ranitidine/zolpidem tartrate combinations revealed no effect of either drug on the pharmacokinetics or pharmacodynamics of zolpidem. Similarly, St. John’s wort, a CYP3A4 inducer, may also decrease the blood levels of zolpidem.

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

Potential Serious Reactions

Ketoconazole, a potent CYP3A4 inhibitor, increased theexposure to and pharmacodynamic effects of zolpidem. Consideration should begiven to using a lower dose of zolpidem when a potent CYP3A4 inhibitor andzolpidem are given together [see CLINICAL PHARMACOLOGY]. Use of St. John’s wort, a CYP3A4 inducer, in combinationwith zolpidem may decrease blood levels of zolpidem and is not recommended. Rifampin, a CYP3A4 inducer, significantly reduced theexposure to and the pharmacodynamic effects of zolpidem. Use of Rifampin incombination with zolpidem may decrease the efficacy of zolpidem and is notrecommended [see CLINICAL PHARMACOLOGY]. The following adverse reactions have been identifiedduring postapproval use of AMBIEN.

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. There was no evidence of an additive effect in psychomotor performance. Cases of angioedema involving the tongue, glottis orlarynx have been reported in patients after taking the first or subsequentdoses of sedative-hypnotics, including zolpidem. Some patients have hadadditional symptoms such as dyspnea, throat closing or nausea and vomiting thatsuggest anaphylaxis. Some patients have required medical therapy in theemergency department. If angioedema involves the throat, glottis or larynx,airway obstruction may occur and be fatal.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. You may report side effects to FDA at FDA-1088 or at /medwatch. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Take this medication by mouth on an empty stomach as directed by your doctor, usually once a night.

The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next-day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS]. The total dose of AMBIEN should not exceed 10 mg once daily immediately before bedtime.