Zolpidem tartrate 10 mg
Pro Research Analysisby 
Searched over 200M research papers
Zolpidem Tartrate 10 mg: Pharmacokinetics, Bioequivalence, and Clinical Insights
Bioequivalence of Zolpidem Tartrate 10 mg Tablets
Bioequivalence Studies
Several studies have evaluated the bioequivalence of different brands of zolpidem tartrate 10 mg tablets. A study comparing Zanilo and Stilnox tablets in healthy male volunteers found that both formulations met the criteria for bioequivalence set by the Korea Food and Drug Administration (KFDA). The pharmacokinetic parameters such as the area under the plasma concentration-time curve (AUC) and maximum plasma drug concentration (Cmax) were within the acceptable range, indicating that Zanilo is bioequivalent to Stilnox . Another study confirmed the bioequivalence of two different zolpidem tartrate formulations in 24 healthy male volunteers, with both primary target parameters AUC and Cmax falling within the acceptable limits . Additionally, a study involving domestic and imported zolpidem tartrate tablets also demonstrated bioequivalence, with no significant differences in pharmacokinetic parameters .
Pharmacokinetics of Zolpidem Tartrate
Pharmacokinetic Parameters
The pharmacokinetics of zolpidem tartrate have been extensively studied across different populations. In a study involving five Chinese ethnic groups, no significant differences were found in the pharmacokinetic parameters of zolpidem tartrate among the groups. However, gender differences were noted, with males metabolizing the drug faster than females . Another study comparing Hui and Han healthy volunteers also found no significant differences in pharmacokinetic parameters between the two ethnic groups .
Combination with Other Drugs
The pharmacokinetics of zolpidem tartrate when taken in combination with gabapentin were also investigated. The study found that the pharmacokinetics of both drugs were unaffected when taken together compared to when each drug was taken alone. The 90% confidence intervals for Cmax and AUC fell within the range accepted for bioequivalence, indicating no significant interaction between the two drugs .
Clinical Efficacy and Safety
Clinical Efficacy
Zolpidem tartrate is a non-benzodiazepine hypnotic used for the treatment of insomnia. It has been shown to decrease sleep latency and increase total sleep time and sleep efficiency without affecting sleep architecture. Clinical studies have demonstrated its effectiveness in increasing sleep time and decreasing sleep latency, with efficacy comparable to benzodiazepines but without causing rebound insomnia or withdrawal effects .
Safety and Tolerability
Zolpidem tartrate is generally well-tolerated, with adverse reactions primarily being dose-related and involving the central nervous system and gastrointestinal tract. The drug exhibits high-affinity binding at a benzodiazepine-receptor subtype located in the cerebellum and cerebral cortex, which contributes to its sedative and hypnotic effects .
Modified-Release Formulations
To address the short duration of action of zolpidem tartrate, modified-release formulations have been developed. These formulations use a biphasic delivery system to provide both immediate and extended release of the drug, thereby lengthening its duration of action. Studies have shown that these modified-release tablets meet the United States Pharmacopeia (USP) guidelines for zolpidem tartrate extended-release tablets and exhibit a release pattern consistent with Fickian diffusion .
Conclusion
Zolpidem tartrate 10 mg is a widely studied hypnotic agent with proven bioequivalence across different brands and formulations. Its pharmacokinetics are consistent across various ethnic groups, although gender differences in metabolism have been noted. The drug is effective in treating insomnia, with a safety profile that is generally well-tolerated. Modified-release formulations offer an extended duration of action, providing additional therapeutic options for patients.
Sources and full results
Most relevant research papers on this topic