FDA Warning: Driving May Be Impaired the Morning Following Sleeping Pill Use

JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 02/2013; 309(7):645-6. DOI: 10.1001/jama.2013.323
Source: PubMed
1 Read
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Severely burned patients frequently experience sleep fragmentation and insomnia. This study evaluated the population pharmacokinetics of the sleep-enhancing agent zolpidem among burned children. Zolpidem was administered according to the following age-based dosing schedule: 2.5 mg per dose for 2-4 year olds, 5.0 mg per dose for 5-10 year olds, and 10 mg per dose for older than 10 years. Serum samples were collected before and 1, 2, 4, 5, 6, and 8 hours after dosing. The population pharmacokinetic analysis modeled zolpidem concentrations using nonlinear mixed effects models. Eleven patients with a mean (±SD) age of 8.3 ± 4.0 years and a mean total burn surface area of 56% ± 22% were recruited. Seventy-three zolpidem concentrations were measured with a mean Cmax of 291 ± 140 ng/mL. A 2-compartment model with first-order absorption best described the data. Zolpidem clearance was estimated at 0.03 L·h·kg (relative standard error, 55%) and increased with body weight (P < 0.05). The central compartment volume of distribution was estimated at 0.05 L/kg (relative standard error, 25%), which was inversely related to the proportion of the body surface with third-degree burns (P < 0.001). A population pharmacokinetic model has been developed that reliably characterized the pharmacokinetic parameters of zolpidem when used as a sleep-enhancing agent among pediatric burn patients. Additional studies are needed to link this pharmacokinetic model with pharmacodynamic data, which may include an assessment of the effects of higher zolpidem doses and/or more frequent administration upon sleep architecture.
    Full-text · Article · Dec 2013 · Therapeutic drug monitoring
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Research on the specific effects of sex and gender on pharmacokinetics and pharmacodynamics, as well as safety profile tolerability and drug efficacy, of medications remain meager because female animals and women have only recently been included in the pharmacological domain. To date, the influence of sex and gender on access to care and emotional factors, including patients and care provider dyads, the placebo effect, adherence, and safety profiles, are discussed. Furthermore, differences in drug responses, mainly for antidiabetic drugs, have been described. However, further studies are needed to explore the impact of sex and gender on reaching the most appropriate and tailored prescription for each patient, regardless of sex and gender.
    Full-text · Article · May 2014 · Expert Review of Clinical Pharmacology
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background Recent warnings from the FDA have highlighted the potential risks associated with zolpidem use. These risks may be especially acute in nonmedical users of zolpidem, but little work has examined the characteristics of such nonmedical users. This study aims to investigate the correlates of nonmedical use of zolpidem (NUPZ) across the lifespan and potential age cohort-based differences in NUPZ correlates. Methods Data from the 2009–2011 versions of the National Survey on Drug Use and Health were used (n = 174,667). Analyses used weighted design-based logistic regressions to examine a set of substance use and mental health correlates within five separate age cohorts and differences in correlate magnitude between these cohorts. Results Most examined substance use and mental health variables were significant correlates of NUPZ, though odds ratio (OR) magnitude tended to drop with increasing age. Age-based differences were most apparent for substance use correlates of both lifetime and past year NUPZ, with significantly higher ORs in adolescent nonmedical users. Mental health variables operated more consistently across age, with OR magnitudes that were generally in the same range, regardless of age cohort. Conclusions Age-based differences in NUPZ correlates suggest motives may change for NUPZ through the lifespan, though this cannot be established with the cross-sectional data used in this work. Clinicians screening for NUPZ should emphasize such screening in high-risk individuals with substance use and/or mental health problems.
    No preview · Article · Sep 2014 · Addictive Behaviors
Show more