{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T12:31:48Z","timestamp":1777725108150,"version":"3.51.4"},"reference-count":39,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[1995,1,1]],"date-time":"1995-01-01T00:00:00Z","timestamp":788918400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Int Med Res"],"published-print":{"date-parts":[[1995,1]]},"abstract":"<jats:p>A multicentre post-marketing surveillance study was conducted in Switzerland in routine practice and involved 1972 insomniac patients treated with zolpidem, an imidazopyridine hypnotic agent. The patients were representative of the general insomniac population (65% women; mean age 55 years; 29% over 65). Of the patients, 87% were treated with a zolpidem dosage of 10 mg\/day and the median treatment duration was 30 days. All adverse events were collected through spontaneous reporting. A total of 175 patients (8.9%) reported 343 adverse events, and 102 (5.2%) of them discontinued treatment. CNS (central nervous system)-related adverse events accounted for 66% of the total, the most common events being residual daytime sedation and insufficient efficacy in 3.7% and 1.6%, respectively; confusion, disorientation, nervousness, nightmares, amnesia, impaired concentration and anxiety were observed in a lower proportion. Gastro-intestinal symptoms, headache and skin reactions were the most frequent non-CNS related effects. No serious adverse event was reported and no new risk factors or at-risk populations were identified. The safety profile of zolpidem is thus consistent with its known pharmacological properties, the results of previous clinical trials, and the cumulative international experience gained with this short-acting hypnotic drug.<\/jats:p>\n                  <jats:p>Eine multizentrische c in der Schweiz durchgef\u00fchrt. 1972 Patienten mit Schlafst\u00f6rung wurden mit Zolpidem, einem Imidazopyridin-Hypnotikum, behandelt. Die Patienten waren f\u00fcr die schlafgest\u00f6rte Population repr\u00e4sentativ (65% Frauen; mittleres Alter 55 Jahre; 29% der Patienten \u00e4lter als 65 Jahre). 87% der Patienten erhielten pro Tag 10 mg Zolpidem und der Median der Therapiedauer betrug 30 Tage. Alle spontan berichteten Symptome wurden zusammengestellt. Bei 175 Patienten (8.9%) traten insgesamt 343 unerw\u00fcnschte Wirkungen auf und 102 Patienten (5.2%) brachen die Therapie deswegen ab. Zwei Drittel der unerw\u00fcnschten Ereignisse betrafen das zentrale Nervensystem (ZNS), am h\u00e4ufigsten anhaltende morgendliche Sedation und mangelhafte Wirkung in 3.7% resp. 1.6%; Konfusion, Orientierungsst\u00f6rung, Nervosit\u00e4t, Alptr\u00e4ume, Amnesie, Konzentrationsst\u00f6rung und Angst wurden seltener berichtet. Gastrointestinale Symptome, Kopfschmerzen und Hautreaktionen waren die h\u00e4ufigsten organisch bedingten Symptome. Es traten keine schwerwiegende unerw\u00fcnschte Wirkungen auf, ebenso wurden keine neuen Risikofaktoren oder Risikopopulationen festgestellt. Somit ist das Vertr\u00e4glichkeitsprofil von Zolpidem mit den bekannten pharmakologischen Eigenschaften gut vereinbar und entspricht den Resultaten aus bisherigen klinischen Studien und den internationalen Erfahrungen, die mit diesem kurzwirksamen Hypnotikum erworben worden sind.<\/jats:p>","DOI":"10.1177\/030006059502300108","type":"journal-article","created":{"date-parts":[[2017,1,10]],"date-time":"2017-01-10T19:48:36Z","timestamp":1484077716000},"page":"61-73","source":"Crossref","is-referenced-by-count":51,"title":["Zolpidem in Insomnia: A 3-Year Post-Marketing Surveillance Study in Switzerland"],"prefix":"10.1177","volume":"23","author":[{"given":"E","family":"Ganzoni","sequence":"first","affiliation":[{"name":"Synth\u00e9labo Pharma, Lausanne, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J Ph","family":"Santoni","sequence":"additional","affiliation":[{"name":"Synth\u00e9labo Group, Le Plessis Robinson, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V","family":"Chevillard","sequence":"additional","affiliation":[{"name":"Synth\u00e9labo Group, Le Plessis Robinson, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M","family":"S\u00e9bille","sequence":"additional","affiliation":[{"name":"Synth\u00e9labo Group, Le Plessis Robinson, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B","family":"Mathy","sequence":"additional","affiliation":[{"name":"Synth\u00e9labo Group, Le Plessis Robinson, France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[1995,1,1]]},"reference":[{"key":"bibr1-030006059502300108","first-page":"155","volume-title":"Imidazopyridines in Sleep Disorders: A Novel Experimental and Therapeutic Approach","author":"Bianchetti G","year":"1988"},{"key":"bibr2-030006059502300108","first-page":"139","volume-title":"Imidazopyridines in Sleep Disorders: A Novel Experimental and Therapeutic Approach","author":"Th\u00e9not JP","year":"1988"},{"key":"bibr3-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1016\/0091-3057(88)90202-X"},{"key":"bibr4-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1016\/0006-8993(93)90375-W"},{"key":"bibr5-030006059502300108","first-page":"97","volume-title":"Imidazopyridines in Sleep Disorders: A Novel Experimental and Therapeutic Approach","author":"Zivkovic B","year":"1988"},{"key":"bibr6-030006059502300108","first-page":"219","volume-title":"Insomnie et Imidazopyridines","author":"Zivkovic B","year":"1990"},{"key":"bibr7-030006059502300108","first-page":"231","volume-title":"Imidazopyridines in Sleep Disorders: A Novel Experimental and Therapeutic Approach","author":"Nicholson AN","year":"1988"},{"key":"bibr8-030006059502300108","first-page":"375","volume-title":"Imidazopyridines in Sleep Disorders: A Novel Experimental and Therapeutic Approach","author":"Blois R","year":"1988"},{"key":"bibr9-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1177\/030006059202000208"},{"key":"bibr10-030006059502300108","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199040020-00008"},{"key":"bibr11-030006059502300108","first-page":"267","volume":"17","author":"Walsh JK","year":"1988","journal-title":"Sleep Res"},{"key":"bibr12-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1093\/sleep\/14.5.399"},{"key":"bibr13-030006059502300108","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1111\/j.1365-2869.1992.tb00033.x","volume":"1","author":"Monti J","year":"1992","journal-title":"J Sleep Res"},{"key":"bibr14-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1177\/030006059302100402"},{"key":"bibr15-030006059502300108","first-page":"379","volume":"18","author":"Lavoisy J","year":"1992","journal-title":"Enc\u00e9phale"},{"issue":"3","key":"bibr16-030006059502300108","doi-asserted-by":"crossref","first-page":"1246","DOI":"10.1016\/S0022-3565(25)23193-7","volume":"255","author":"Evans S","year":"1990","journal-title":"J Pharmacol Exp Ther"},{"key":"bibr17-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1097\/00002826-199201001-00059"},{"key":"bibr18-030006059502300108","volume-title":"Guidelines Concerning Requirements of a Documentation for Registration of Human Drugs (Registration Guidelines).","year":"1977"},{"key":"bibr19-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.296.6619.399"},{"key":"bibr20-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.1985.01790260019002"},{"key":"bibr21-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1990.03440130073028"},{"key":"bibr22-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.304.6840.1470"},{"key":"bibr23-030006059502300108","doi-asserted-by":"publisher","DOI":"10.1016\/0140-6736(93)91763-C"},{"key":"bibr24-030006059502300108","unstructured":"Ambien\u00ae (zolpidem tartrate). 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