Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes
نویسندگان
چکیده
BACKGROUND Women have higher morning serum zolpidem concentrations than men after taking an evening dose, potentially leading to increased risk of harm. On 19 April 2013, the United States Food and Drug Administration required labeling changes for zolpidem, recommending an initial dose of no greater than 5 mg (immediate release) or 6.25 mg (controlled release) per night in women. OBJECTIVES The primary objective of this study was to compare prescribing practices before and after the 2013 zolpidem labeling change. A secondary objective was to evaluate serious adverse events potentially related to zolpidem. METHODS Electronic medical records of adults receiving care through the University of Colorado Health system were accessed for study inclusion if patients were provided a first-time prescription for zolpidem either prior to or after the Food and Drug Administration labeling change. Patients were randomly chosen from eight strata based on age, gender, and date of zolpidem initiation (before/after the labeling change). Demographic and zolpidem prescribing data were collected. Low-dose zolpidem was considered 5 mg (immediate release) or 6.25 mg (controlled release) daily or less. Documentation of potentially related serious adverse events within the patients' records was also evaluated. RESULTS A total of 400 patients were included in the study. The overall percentage of patients prescribed low-dose zolpidem increased from 44% to 58% after the labeling change (p = 0.0020). In a pre-specified subgroup analysis, the percentage of patients prescribed low-dose zolpidem increased in all groups, including young men (38%-50%, p = 0.23), elderly men (34%-40%, p = 0.53), and elderly women (60%-74%, p = 0.14), but the change was only significant in young women (42%-70%, p = 0.0045). CONCLUSION After Food and Drug Administration-mandated labeling changes for zolpidem in 2013, the percentage of overall patients in our health system, and specifically young women, with initial prescriptions for low-dose zolpidem significantly increased as compared to before the labeling change.
منابع مشابه
Influence of education on knowledge, attitude and practices of students of Isfahan University of Medical Sciences to traffic light inserted on food labeling
Background: Nutrition education and introduction of procedures for choosing healthier food have an important role to reduce the rate of non-communicable diseases. It was shown the amount of risk factors of non-communicable diseases such as energy, salt, sugar, fat and trans fatty acid on the traffic light of food labelling. The status of risk is presented through three colors of red, yellow and...
متن کاملMedication Errors Associated With Adverse Drug Reactions in Iran (2015-2017): A P-Method Approach
Medication errors are the second most common cause of adverse patient safety incidents and the single most common preventable cause of adverse events in medical practice. Given the high human fatalities and financial burden of medication errors for healthcare systems worldwide, reducing their occurrence is a global priority. Therefore, appropriate policies to reduce medication errors, using nat...
متن کاملFast-Acting Sublingual Zolpidem for Middle-of-the-Night Wakefulness
Sleep disorders (somnipathies) are conditions characterized by disruptions of sleep quality or of sleep pattern. They can involve difficulty falling asleep (prolonged sleep onset latency), difficulty staying asleep (disturbance of sleep maintenance), sleep of poor quality (unrefreshing), or combinations of these and can lead to poor health and quality of life problems. A subtype of sleep-mainte...
متن کاملA case of zaleplon-induced amnestic sleep-related eating disorder.
To the Editor: Sleep-related eating disorder (SRED) is a type of sleep disorder in which the individual is amnestic completely or partially to the eating episode, which occurs during NREM sleep. Several medications have been implicated in unusual sleep behaviors, and the US Food and Drug Administration (FDA) has recommended revised labeling on these medications. Zolpidem has the most published ...
متن کاملAn overview of upcoming changes in pregnancy and lactation labeling information
BACKGROUND Many medications can be used safely and effectively to provide health benefits for disease state management during pregnancy with minimal risk to the fetus or mother. Today nine out of ten women take at least one medication during pregnancy, and the number of women taking four or more medications has more than doubled over the past 30 years. However, the lack of safety data combined ...
متن کامل