We also factor in user generated feedback on this form plus a page quality algorithm. Yes Did you find that information valuable? Yes How likely are you to share our page with a friend? Scale 1 to 5 X. Advise patient to take prescribed dose immediately before going to bed. Advise patient taking ER or orally disintegrating zolpidem not to crush, chew, or break the tablet. Advise patient to take on an empty stomach but to take with food if stomach upset occurs.
Instruct patient receiving orally disintegrating tablet to place tablet in the mouth, where it will dissolve in seconds and then be swallowed with saliva.
Inform patient that the orally disintegrating tablet may be taken with or without water. Caution patient not to take zolpidem unless planning to get 7 to 8 h of sleep before being active again.
Advise patient that taking zolpidem with less than 7 to 8 h of sleep may result in daytime drowsiness, amnesia, or memory problems. Review safety precautions with regard to falls, especially for elderly and debilitated patients. The effect of drugs that induce or inhibit other P enzymes on the exposure to zolpidem is not known. Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem and is not recommended [see Clinical Pharmacology John's wort Use of St.
John's wort, a CYP3A4 inducer, in combination with zolpidem may decrease blood levels of zolpidem and is not recommended. Consideration should be given to using a lower dose of zolpidem when a potent CYP3A4 inhibitor and zolpidem are given together [see Clinical Pharmacology Studies in children to assess the effects of prenatal exposure to zolpidem have not been 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 drugs 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 Extended-Release Tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the Zolpidem Tartrate Extended-Release Tablets maximum recommended human dose MRHD of Nursing Mothers Zolpidem is excreted in human milk.
Caution should be exercised when Zolpidem Tartrate Extended-Release Tablets are administered to a nursing woman.
Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established. Ten patients on zolpidem 7. FDA has not required pediatric studies of Zolpidem Tartrate Extended-Release Tablets in the pediatric population based on these efficacy and safety findings.
Gender Difference in Pharmacokinetics Women clear zolpidem tartrate from the body at a lower rate than men. Between 6 and 12 hours after dosing, zolpidem concentrations were 2- to 3 fold higher in adult female compared to adult male subjects. Given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of Zolpidem Tartrate Extended-Release Tablets for adult women is 6. In geriatric patients, clearance of zolpidem is similar in men and women.
Hepatic Impairment The recommended dose of Zolpidem Tartrate Extended-Release Tablets in patients with mild to moderate hepatic impairment is 6. Avoid Zolpidem Tartrate Extended-Release Tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Dosage and Administration 2.
Drug Abuse and Dependence Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation. Abuse Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time.
The mean plasma concentration-time profiles are shown in Figure 1. Mean plasma concentration-time profiles for zolpidem tartrate extended-release Absorption Following administration of zolpidem tartrate extended-release tablets, administered as a single A food-effect study in 45 healthy subjects compared the pharmacokinetics of zolpidem tartrate extended-release tablets The half-life was not changed.
These results suggest that, for faster sleep onset, zolpidem tartrate extended-release tablets should not be administered with or immediately after a meal. Distribution Total protein binding was found to be Metabolism Zolpidem is converted to inactive metabolites that are eliminated primarily by renal excretion. Elimination When zolpidem tartrate extended-release tablets were administered as a single Special Populations Elderly In 24 elderly greater than or equal to 65 years healthy subjects administered a single 6.
Hepatic Impairment Zolpidem tartrate extended-release tablets were not studied in patients with hepatic impairment. The pharmacokinetics of an immediate-release formulation of zolpidem tartrate in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects.
No dosage adjustment in renally impaired patients is required; however, these patients should be closely monitored. A study in subjects with hepatic impairment did reveal prolonged elimination in this group; therefore, treatment should be initiated with zolpidem tartrate ER 6.
Use in patients with depression: Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.
Use in pediatric patients: Safety and effectiveness of zolpidem has not been established in pediatric patients. In an 8-week study in pediatric patients aged years with insomnia associated with ADHD given an immediate-release oral solution of zolpidem tartrate, zolpidem did not decrease sleep latency compared to placebo. Hallucinations were reported in 7. In a 6-month study in adult patients years of age , 8. Reactions most commonly associated with discontinuation of zolpidem tartrate ER included anxiety anxiety, restlessness or agitation reported in 1.
Most commonly observed adverse reactions in controlled trials: During treatment with zolpidem tartrate ER in adults and elderly at daily doses of In the 6-month trial evaluating zolpidem tartrate ER Events reported by investigators were classified utilizing the MedDRA dictionary 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 tables were derived from results of two placebo-controlled efficacy trials involving zolpidem tartrate ER. These trials involved patients with primary insomnia who were treated for 3 weeks with zolpidem tartrate ER at doses of 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.
Zolpidem tartrate is classified as a Schedule IV controlled substance under the controlled Substances Act.
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