Zolpidem
Zolpidem
Klass: C
Visa all info
Skriv ut
Kontakta oss
Produkter
Visa alla produkter
Edluar, Stilnoct, Zolpic, Zolpidem Actavis, Zolpidem Au......
Edluar, Stilnoct, Zolpic, Zolpidem Actavis, Zolpidem Aurobindo, Zolpidem Dune, Zolpidem HEXAL, Zolpidem Orifarm, Zolpidem STADA, Zolpidem Sandoz, Zolpidem Tartrate, Zolpidem Viatris, Zolpidem Vitabalans, Zolpidem Winthrop, Zolpidem ratiopharmATC-koder
N05CF02
N05CF02Substanser
zolpidem, zolpidemtartrat
zolpidem, zolpidemtartratSammanfattning
Kvinnor metaboliserar zolpidem långsammare än män. Det finns enstaka studier som har analyserat skillnader i effekt och biverkningar mellan kvinnor och män men mängden klinisk relevans är oklar. Små studier har visat att kvinnor har högre självskattad dåsighet och sämre bilkörningsförmåga efter intag av 10 mg zolpidem. Lägre dos till kvinnor kan övervägas.
Kvinnor metaboliserar zolpidem långsammare än män. Det finns enstaka studier som har analyserat skillnader i effekt och biverkningar mellan kvinnor och män men mängden klinisk relevans är oklar. Små studier har visat att kvinnor har högre självskattad dåsighet och sämre bilkörningsförmåga efter intag av 10 mg zolpidem. Lägre dos till kvinnor kan övervägas.Background
Pharmacokinetics and dosing
Visa hela bakgrundstexten
Zolpidem has a short half-life, 2.4 h. Pharmacokinetic studies of zolpidem in healthy young men and women show that men had significantly higher apparent clearance than women. After correction for body weight, the sex difference in clearance was still statistically significant in four of the studies [3-8]. Pooled mean apparent clearance corrected for body weight was 25% lower in women than in men (3.75 vs. 4.98 ml/min/kg, p<0.002) [8].
Women appear to eliminate zolpidem slower than men but the mechanism behind this sex difference is not established. In 2013, the U.S. Food and Drug Administration (FDA) recommended a 50% lower initial dose of zolpidem to women [9, 10]. However, this action has been criticized for the lack of available scientific evidence to support the recommendation of reduced dosage to women [8].
Effect
A few studies have evaluated sex differences in the relation between zolpidem pharmacokinetics or plasma concentrations and pharmacodynamic responses. The pharmacodynamics of a single dose zolpidem (1.0, 1.75, or 3.5 mg) or placebo wa......
Försäljning på recept
Visa hela försäljning på recept
Fler kvinnor än män hämtade ut tabletter innehållande zolpidem (ATC-kod N05CF02) på recept i Sverige år 2020, totalt 119 750 kvinnor och 60 336 män. Det motsvarar 23 respektive 12 personer per tusen invånare. Andelen som hämtat ut läkemedel ökade med stigande ålder hos båda könen. I genomsnitt var tabletter innehållande zolpidem 1,8 gånger vanligare hos kvinnor [24].
Referenser
Visa referenser
Staner L, Ertlé S, Boeijinga P, Rinaudo G, Arnal MA, Muzet A et al. Next-day residual effects of hypnotics in DSM-IV primary insomnia: a driving simulator study with simultaneous electroencephalogram monitoring. Psychopharmacology (Berl). 2005;181:790-8.
Vermeeren A, Vuurman EF, Leufkens TR, Van Leeuwen CJ, Van Oers AC, Laska E et al. Residual effects of low-dose sublingual zolpidem on highway driving performance the morning after middle-of-the-night use. Sleep. 2014;37:489-96.
Greenblatt DJ, Harmatz JS, von Moltke LL, Wright CE, Durol AL, Harrel-Joseph LM et al. Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: evaluation of sex-dependent differences. J Pharmacol Exp Ther. 2000;293:435-43.
Olubodun JO, Ochs HR, von Moltke LL, Roubenoff R, Hesse LM, Harmatz JS et al. Pharmacokinetic properties of zolpidem in elderly and young adults: possible modulation by testosterone in men. Br J Clin Pharmacol. 2003;56:297-304.
Greenblatt DJ, Harmatz JS, Singh NN, Steinberg F, Roth T, Moline ML et al. Gender differences in pharmacokinetics and pharmacodynamics of zolpidem following sublingual administration. J Clin Pharmacol. 2014;54(3):282-90.
Greenblatt DJ, Harmatz JS, Roth T, Singh NN, Moline ML, Harris SC et al. Comparison of pharmacokinetic profiles of zolpidem buffered sublingual tablet and zolpidem oral immediate-release tablet: results from a single-center, single-dose, randomized, open-label crossover study in healthy adults. Clin Ther. 2013;35(5):604-11.
Guo T, Mao G, Zhao L, Xia D, Yang L. Comparative pharmacokinetics of zolpidem tartrate in five ethnic populations of China. Acta Pharm Sin B. 2014;4(2):146-50.
Greenblatt, DJ, Harmatz, JS, and Roth, T. Zolpidem and Gender: Are Women Really At Risk?. Clin Psychopharmacol. 2019;39(3):189-199.
FDA. FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia Drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar and Zolpimist). 2013-01-10.
DailyMed Ambien (zolpidem). DailyMed [www]. US National Library of Medicine. [updated 2020-07-22, cited 2021-02-16].
Verster JC, Roth T. Predicting psychopharmacological drug effects on actual driving performance (SDLP) from psychometric tests measuring driving-related skills. Psychopharmacology (Berl). 2012;220(2):293-301.
Dijk DJ, James LM, Peters S, Walsh JK, Deacon S. Sex differences and the effect of gaboxadol and zolpidem on EEG power spectra in NREM and REM sleep. J Psychopharmacol. 2010;24:1613-8.
Roth T, Steinberg F, Singh NN, Moline M. Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle-of-the-night awakening in insomnia. Hum Psychopharmacol. 2014;29(1):25-30.
Roehrs TA, Roth T. Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem. J Clin Sleep Med. 2016;12(3):319-25.
Verster JC, Roth T. Gender differences in highway driving performance after administration of sleep medication: a review of the literature. Traffic Inj Prev. 2012;13:286-92.
Verster JC, Volkerts ER, Schreuder AH, Eijken EJ, van Heuckelum JH, Veldhuijzen DS, Verbaten MN, Paty I, Darwish M, Danjou P, Patat A. Residual effects of middle-of-the-night administration of zaleplon and zolpidem on driving ability, memory functions, and psychomotor performance. J Clin Psychopharmacol. 2002;22(6):576-83.
Medical Letter on Drugs and Therapeutics. FDA Requires Lower Dosing of Zolpidem. 2013-01-21.
Johnell K, Fastbom J. Gender and use of hypnotics or sedatives in old age: a nationwide register-based study. Int J Clin Pharm. 2011;33:788-93.
Johnell K, Fastbom J. The use of benzodiazpines and related drugs amongst older people in Sweden: associated factors and concomitant use of other psychotropics. Int J Geriatr Psychiatry. 2009;24:731-8.
Andersen AB, Frydenberg M. Long-term use of zopiclone, zolpidem and zaleplon among Danish elderly and the association with sociodemographic factors and use of other drugs. Pharmacoepidemiol Drug Saf. 2011;20:378-85.
Hausken AM, Furu K, Skurtveit S, Engeland A, Bramness JG. Starting insomnia treatment: the use of benzodiazepines versus z-hypnotics A prescription database study of predictors. Eur J Clin Pharmacol. 2009;65:295-301.
Norman JL, Fixen DR, Saseen JJ, Saba LM, Linnebur SA. Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes. SAGE Open Med. 2017;5:2050312117707687.
Kesselheim AS, Donneyong M, Dal Pan GJ, Zhou EH, Avorn J, Schneeweiss S, Seeger JD. Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications. Pharmacoepidemiol Drug Saf. 2017;26(6):712-721.
Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]
- Staner L, Ertlé S, Boeijinga P, Rinaudo G, Arnal MA, Muzet A et al. Next-day residual effects of hypnotics in DSM-IV primary insomnia: a driving simulator study with simultaneous electroencephalogram monitoring. Psychopharmacology (Berl). 2005;181:790-8.
- Vermeeren A, Vuurman EF, Leufkens TR, Van Leeuwen CJ, Van Oers AC, Laska E et al. Residual effects of low-dose sublingual zolpidem on highway driving performance the morning after middle-of-the-night use. Sleep. 2014;37:489-96.
- Greenblatt DJ, Harmatz JS, von Moltke LL, Wright CE, Durol AL, Harrel-Joseph LM et al. Comparative kinetics and response to the benzodiazepine agonists triazolam and zolpidem: evaluation of sex-dependent differences. J Pharmacol Exp Ther. 2000;293:435-43.
- Olubodun JO, Ochs HR, von Moltke LL, Roubenoff R, Hesse LM, Harmatz JS et al. Pharmacokinetic properties of zolpidem in elderly and young adults: possible modulation by testosterone in men. Br J Clin Pharmacol. 2003;56:297-304.
- Greenblatt DJ, Harmatz JS, Singh NN, Steinberg F, Roth T, Moline ML et al. Gender differences in pharmacokinetics and pharmacodynamics of zolpidem following sublingual administration. J Clin Pharmacol. 2014;54(3):282-90.
- Greenblatt DJ, Harmatz JS, Roth T, Singh NN, Moline ML, Harris SC et al. Comparison of pharmacokinetic profiles of zolpidem buffered sublingual tablet and zolpidem oral immediate-release tablet: results from a single-center, single-dose, randomized, open-label crossover study in healthy adults. Clin Ther. 2013;35(5):604-11.
- Guo T, Mao G, Zhao L, Xia D, Yang L. Comparative pharmacokinetics of zolpidem tartrate in five ethnic populations of China. Acta Pharm Sin B. 2014;4(2):146-50.
- Greenblatt, DJ, Harmatz, JS, and Roth, T. Zolpidem and Gender: Are Women Really At Risk?. Clin Psychopharmacol. 2019;39(3):189-199.
- FDA. FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia Drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar and Zolpimist). 2013-01-10.
- DailyMed Ambien (zolpidem). DailyMed [www]. US National Library of Medicine. [updated 2020-07-22, cited 2021-02-16].
- Verster JC, Roth T. Predicting psychopharmacological drug effects on actual driving performance (SDLP) from psychometric tests measuring driving-related skills. Psychopharmacology (Berl). 2012;220(2):293-301.
- Dijk DJ, James LM, Peters S, Walsh JK, Deacon S. Sex differences and the effect of gaboxadol and zolpidem on EEG power spectra in NREM and REM sleep. J Psychopharmacol. 2010;24:1613-8.
- Roth T, Steinberg F, Singh NN, Moline M. Gender influences on efficacy and safety of sublingual zolpidem tartrate for middle-of-the-night awakening in insomnia. Hum Psychopharmacol. 2014;29(1):25-30.
- Roehrs TA, Roth T. Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem. J Clin Sleep Med. 2016;12(3):319-25.
- Verster JC, Roth T. Gender differences in highway driving performance after administration of sleep medication: a review of the literature. Traffic Inj Prev. 2012;13:286-92.
- Verster JC, Volkerts ER, Schreuder AH, Eijken EJ, van Heuckelum JH, Veldhuijzen DS, Verbaten MN, Paty I, Darwish M, Danjou P, Patat A. Residual effects of middle-of-the-night administration of zaleplon and zolpidem on driving ability, memory functions, and psychomotor performance. J Clin Psychopharmacol. 2002;22(6):576-83.
- Medical Letter on Drugs and Therapeutics. FDA Requires Lower Dosing of Zolpidem. 2013-01-21.
- Johnell K, Fastbom J. Gender and use of hypnotics or sedatives in old age: a nationwide register-based study. Int J Clin Pharm. 2011;33:788-93.
- Johnell K, Fastbom J. The use of benzodiazpines and related drugs amongst older people in Sweden: associated factors and concomitant use of other psychotropics. Int J Geriatr Psychiatry. 2009;24:731-8.
- Andersen AB, Frydenberg M. Long-term use of zopiclone, zolpidem and zaleplon among Danish elderly and the association with sociodemographic factors and use of other drugs. Pharmacoepidemiol Drug Saf. 2011;20:378-85.
- Hausken AM, Furu K, Skurtveit S, Engeland A, Bramness JG. Starting insomnia treatment: the use of benzodiazepines versus z-hypnotics A prescription database study of predictors. Eur J Clin Pharmacol. 2009;65:295-301.
- Norman JL, Fixen DR, Saseen JJ, Saba LM, Linnebur SA. Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes. SAGE Open Med. 2017;5:2050312117707687.
- Kesselheim AS, Donneyong M, Dal Pan GJ, Zhou EH, Avorn J, Schneeweiss S, Seeger JD. Changes in prescribing and healthcare resource utilization after FDA Drug Safety Communications involving zolpidem-containing medications. Pharmacoepidemiol Drug Saf. 2017;26(6):712-721.
- Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]
Uppdaterat
Litteratursökningsdatum 2/16/2021
Litteratursökningsdatum 2/16/2021Se även
Zopiklon