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The third section focuses on drug-drug interactions. Psychotropic medications from different categories are frequently prescribed together,or alongside medications used to treat comorbid conditions, and the information provided is directly relevant to the clinic, as a result. The clinical application of pharmacokinetics and pharmacodynamics of CNS agents has made significant progress over the past 50 years and new information is reported by numerous publications in psychiatry, neurology, and pharmacology.
Our understanding of the interrelationship between these medications, receptors, drug transporters, as well as techniques for measurement and monitoring their interactions,isfrequently updated. However, with information presented on a host of different platforms, and in different formats, obtaining the full picture can be difficult. This title aims to collate this information into a single source that can be easily interpreted and applied towards patient care by the clinical practitioner, and act as a reference for all others who have an interest in psychopharmacological agents.
Editors view affiliations Michael W. Front Matter Pages i-xiv. Front Matter Pages Finley, Jennifer Le, Kelly C. Anesthetic Drugs Pharmacokinetics and Pharmacodynamics. Clinically Significant Interactions with Antipsychotics. About this book Introduction This book is a comprehensive resource on psychotropic medications, detailing the latest methods for defining their characteristics, their use in different patient populations, and drug-drug interactions; an important collection of information forclinicians, students, researchers, and members of the pharmaceutical industry alike.
It is important to emphasize that, although the events reported did occur during treatment with Zolpidem Tartrate, 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 peripheral nervous system: Hematologic and lymphatic system: Liver and biliary system: The following adverse reactions have been identified during post-approval use of Zolpidem Tartrate Extended-Release Tablets.
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. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability [see Warnings and Precautions 5. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs.
Similarly, chlorpromazine in combination with zolpidem produced 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 in psychomotor performance [see Clinical Pharmacology Some compounds known to induce or inhibit CYP3A may affect exposure to zolpidem. The effect of drugs that induce or inhibit other P enzymes on the exposure to zolpidem is not known. Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem.
Use of Rifampin in combination with zolpidem may decrease the efficacy of zolpidem and is not recommended [see Clinical Pharmacology John's wort, a CYP3A4 inducer, in combination with zolpidem may decrease blood levels of zolpidem and is not recommended. 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 potent CYP3A4 inhibitor and zolpidem are given together [see Clinical Pharmacology There are no adequate and well-controlled studies of Zolpidem Tartrate Extended-Release Tablets in pregnant women. 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 Zolpidem Tartrate Extended-Release Tablets have no established use in labor and delivery [see Pregnancy 8. Zolpidem is excreted in human milk. Caution should be exercised when Zolpidem Tartrate Extended-Release Tablets are administered to a nursing woman.
Zolpidem Tartrate Extended-Release Tablets are not recommended for use in children. 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. 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.
The recommended dose of Zolpidem Tartrate Extended-Release Tablets in patients with mild to moderate hepatic impairment is 6. Zolpidem tartrate is classified as a Schedule IV controlled substance by federal regulation. 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.
Tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: Drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common.
Studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg effects were difficult to distinguish from placebo. Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic.
These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received. General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate.
Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be 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 general supportive measures employed.
Hypotension and CNS depression should be monitored and treated by appropriate medical intervention. Sedating drugs should be withheld following zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment 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 be considered.
The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage. Zolpidem Tartrate Extended-Release Tablets are available in 6. It has the following structure:. Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of Zolpidem Tartrate Extended-Release Tablet consists of a coated two-layer tablet: Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties.
It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. This selective binding of zolpidem on the BZ 1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep stages 3 and 4 in human studies of zolpidem tartrate at hypnotic doses.
Zolpidem Tartrate Extended-Release Tablets exhibit biphasic absorption characteristics, which results in rapid initial absorption from the gastrointestinal tract similar to zolpidem tartrate immediate-release, then provides extended plasma concentrations beyond three hours after administration. A study in 24 healthy male subjects was conducted to compare mean zolpidem plasma concentration-time profiles obtained after single oral administration of Zolpidem Tartrate Extended-Release Tablets The mean plasma concentration-time profiles are shown in Figure 1.
In adult and elderly patients treated with Zolpidem Tartrate Extended-Release Tablets, there was no evidence of accumulation after repeated once-daily dosing for up to two weeks. 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.
Total protein binding was found to be 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. Following a single mg oral zolpidem tartrate dose, mean C max and AUC were found to be two times vs.
T max did not change. The mean half-life in cirrhotic patients of 9. Zolpidem Tartrate Extended-Release Tablets were not studied in patients with renal impairment. No statistically significant differences were observed for C max , T max , half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared after 14 or 21 days. Zolpidem pharmacokinetics were not significantly different in renally-impaired patients.
No dosage adjustment is necessary in patients with compromised renal function. Similarly, chlorpromazine in combination with zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration.
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 7: Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem. A single-dose interaction study with zolpidem tartrate 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions.
There was no evidence of an additive effect in psychomotor performance. Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P enzymes on the pharmacokinetics of zolpidem is unknown. There were no pharmacodynamic effects of zolpidem detected on subjective drowsiness, postural sway, or psychomotor performance.
Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem [see Drug Interactions 7. Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects. In mice, these doses are approximately 2, 9, and 40 times the maximum recommended human dose MRHD of No evidence of carcinogenic potential was observed in mice.
In rats, renal tumors lipoma, liposarcoma were seen at the mid- and high doses. Zolpidem was negative in in vitro bacterial reverse mutation, mouse lymphoma, and chromosomal aberration and in vivo mouse micronucleus genetic toxicology assays. There was no impairment of fertility at any dose tested. In both studies, in patients treated with Zolpidem Tartrate Extended-Release Tablets, polysomnography showed increased wakefulness at the end of the night compared to placebo-treated patients.
In five clinical studies [three controlled studies in adults 18—64 years of age administered Zolpidem Tartrate Extended-Release Tablets In these studies, no significant decrease in performance was observed eight hours after a nighttime dose. In addition, no evidence of next-day residual effects was detected with Zolpidem Tartrate Extended-Release Tablets In a 6-month study, the overall incidence of next-day somnolence was 5.
Rebound insomnia, defined as a dose-dependent worsening in sleep parameters latency, sleep efficiency, and number of awakenings compared with baseline following discontinuation of treatment, is observed with short- and intermediate-acting hypnotics. In the two 3-week placebo-controlled studies in patients with primary insomnia, a rebound effect was only observed on the first night after abrupt discontinuation of Zolpidem Tartrate Extended-Release Tablets.
On the second night, there was no worsening compared to baseline in the Zolpidem Tartrate Extended-Release Tablets group. In a 6-month placebo-controlled study in which Zolpidem Tartrate Extended-Release Tablets were taken as needed 3 to 7 nights per week , within the first month a rebound effect was observed for Total Sleep Time not for WASO during the first night off medication.
After this first month period, no further rebound insomnia was observed. After final treatment discontinuation no rebound was observed. Zolpidem Tartrate Extended-Release 6. Zolpidem Tartrate Extended-Release Inform patients and their families about the benefits and risks of treatment with Zolpidem Tartrate Extended-Release Tablets. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with Zolpidem Tartrate Extended-Release Tablets and with each prescription refill.