BLOG

12/11/2018

Zolpidem contraindications side effects

side zolpidem effects contraindications

Zolpidem contraindications side effects

Zolpidem tartrate Dosage Form: Medically reviewed on Dec 1, Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets zolpidem contraindications side been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies 14 ].

The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Use the lowest effective dose for the patient. 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 to 8 hours remaining before the planned time of awakening.

If the 5 mg dose effects 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 contraindications zolpidem that require full alertness [ see Warnings and Precautions 5. The total dose of Zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.

The recommended initial doses for women and men are different because Zolpidem effects is lower in women. Elderly or debilitated patients may be especially sensitive to the effects of Zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions 5.

Dosage adjustment may be necessary when Side effects tartrate tablet is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions 5. Alprazolam for dogs separation anxiety effect of Zolpidem tartrate tablets may be effects by ingestion with or immediately after a meal.

Zolpidem tartrate effects are available in ambien and alzheimers mayo mg and 10 mg strength tablets for oral administration. Tablets are not scored. Zolpidem tartrate tablets 5 mg are pink, film coated, capsule shaped tablets, debossed with "W" on one side and plain on side effects other side. Zolpidem tartrate tablets 10 mg are valium blue pill high, film coated, capsule shaped tablets, debossed with "W" on one side and plain.

Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to Zolpidem. Observed reactions include anaphylaxis and angioedema [ see Ambien and alcohol overdose symptoms and Precautions 5. Zolpidem tartrate, like other sedative-hypnotic drugs, has central nervous system CNS depressant effects.

Co-administration with other CNS depressants e. Dosage adjustments of Zolpidem tartrate and of other concomitant CNS depressants may be necessary when Zolpidem tartrate is administered with such agents because of the potentially additive effects. The use of Zolpidem tartrate with other sedative-hypnotics including other Zolpidem products at bedtime or the middle of the night is not recommended [ see Dosage and Administration 2. The risk of next-day psychomotor impairment, including impaired driving, is increased if Zolpidem tartrate 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 co-administered with other CNS depressants; or if co-administered with other drugs that increase the blood levels of Zolpidem.

Patients should side effects cautioned against driving and other activities requiring complete mental alertness if Zolpidem tartrate is taken in these circumstances [ see Dosage effects Administration 2 and Clinical Studies Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder.

Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Zolpidem. Some patients have had additional symptoms such side zolpidem effects contraindications dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis.

Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Zolpidem should not be rechallenged with effects drug. Some of these changes included decreased inhibition e. Visual and auditory hallucinations have been reported.

Complex behaviors such as "sleep-driving" i. Although behaviors such as "sleep-driving" have occurred with Zolpidem tartrate alone at therapeutic doses, the co-administration of Zolpidem tartrate with alcohol and other Effects depressants increases the risk of such behaviors, as "effects" the use of Zolpidem tartrate at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Zolpidem tartrate should be strongly considered for patients who report a "sleep-driving" episode.

Other complex behaviors e. As effects "sleep-driving", effects usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may "side effects" occur. It can rarely be determined with certainty effects a particular instance of the effects behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions including completed suicideshave been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Zolpidem contraindications side overdosage is more common in this group of patients; therefore, the lowest number of tablets that is feasible should be prescribed effects the patient at any one time.

Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if Zolpidem tartrate is prescribed to patients with compromised respiratory function. Post-marketing reports effects respiratory insufficiency in "effects side" receiving 10 mg of Zolpidem tartrate, most of whom had pre-existing respiratory impairment, have been reported.

The risk of respiratory depression should be considered prior to prescribing Zolpidem tartrate in patients with respiratory impairment including sleep apnea and myasthenia gravis. There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of Zolpidem. Monitor patients for tolerance, abuse, and dependence [ see Drug Abuse and Dependence 9. Zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries.

Severe injuries such as hip fractures and intracranial hemorrhage have been reported. The following serious adverse reactions are discussed in greater detail in other sections of the labeling:. Associated with discontinuation of treatment: Reactions most commonly associated with discontinuation from U. Reactions most commonly associated with discontinuation from these trials were daytime drowsiness 1.

Most commonly observed adverse reactions in 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 effects in effects 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 effects side drug and nondrug factors to the incidence of side effects in zolpidem contraindications population studied.

The following table was derived from results of 11 placebo-controlled short-term Can you take tramadol and ibuprofen. The table is limited what is tramadol hcl for 50mg tab data from doses up to and including 10 mg, the highest dose recommended for use.

The following table was derived from results of three placebo-controlled long-term efficacy trials involving 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 zolpidem contraindications mg. Dose relationship for adverse reactions: There is evidence from dose contraindications zolpidem trials suggesting a dose relationship for many of the adverse reactions associated with Zolpidem use, particularly for certain CNS and side effects adverse events.

Adverse event incidence across the entire preapproval database: Zolpidem tartrate tablets were administered to 3, subjects in clinical trials throughout the U. 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 side effects World Health Organization WHO dictionary of preferred terms.

The frequencies presented, therefore, represent the proportions of the 3, 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 Zolpidem tartrate tablets, 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: Body as a whole: Central and "side zolpidem effects contraindications" nervous system: Hematologic and lymphatic system: Liver and biliary system: Zolpidem tartrate was evaluated in healthy volunteers in tramadol stays in system interaction studies for several CNS drugs.

Similarly, chlorpromazine in combination with Zolpidem phentermine long term results no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance [ see Clinical Pharmacology A study involving haloperidol and Zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of Zolpidem.

The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration [ see Clinical Pharmacology An additive adverse effect on psychomotor performance between alcohol and oral Zolpidem was demonstrated [ see Warnings and Precautions 5. Concomitant administration of Zolpidem and sertraline increases exposure to Zolpidem [ see Clinical Pharmacology There was no evidence of an additive effect effects side psychomotor performance [ see Clinical Zolpidem contraindications side The effect of drugs on other P enzymes on the exposure to Zolpidem is not known.

Rifampin, a CYP3A4 inducer, significantly reduced the exposure effects side and the pharmacodynamic effects of Zolpidem. Use of Rifampin in combination with Zolpidem may decrease the efficacy of Zolpidem. Consideration should be given to using a lower dose of Zolpidem when ketoconazole and Zolpidem are given together. There are no adequate does some tramadol contain codeine in them well-controlled studies of Zolpidem tartrate tablets in pregnant women.

Studies in children to assess the effects of prenatal exposure to Zolpidem have not effects conducted; however, cases of severe neonatal respiratory depression have been reported when Zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic what is better xanax or lexapro may be at risk for withdrawal symptoms during the postnatal period.

Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. Zolpidem tartrate tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Zolpidem tartrate tablets has no established use in labor and delivery [see Pregnancy 8.

Zolpidem is excreted in human milk.