Zolpidem in Insomnia: A 3-Year Post-Marketing Surveillance Study in Switzerland

Abstract

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.

Sleep-related vagotonic effect of zolpidem in rats

“…Unlike traditional hypnotics, it causes only minor effects on sleep patterns and has fewer undesirable effects (Declerck et al 1992). As previously reported, zolpidem rarely caused adverse effects on the cardiovascular system, such as hypotension or tachycardia in animals, healthy humans, and even hemodynamically compromised subjects such as the elderly and astronauts (Mccann et al 1993;Ganzoni et al 1995;Mailliet et al 2001;Shi et al 2003). Reports on the effects of zolpidem on sleep-related autonomic functions, however, are still lacking.…”

Complex Behaviors Related to Zolpidem: An Analysis of Published Clinical Cases from Taiwan

“…30,31 Although post-marketing studies reported low incidences of sleepwalking (0.3e1%), 31 they can be dangerous to patients. 32,33 The incidence reported in Taiwan is considerably higher (5.1%) 20 as shown in one retrospective study listed in Table 2. The authors suggested that amnesia of these events appear to be dosedependent, and that it occurred more frequently at doses higher than 15 mg. Another study by Hwang et al 19 also gave a similar conclusion (Table 2).…”

A new sublingual formulation of zolpidem for the treatment of sleep-onset insomnia

“…However, withdrawal syndrome following gradual withdrawal from IR-zolpidem 10 mg/day for at least 3 months have been evidenced in some patients treated in a randomized, double-blind, placebo-controlled trial [116]. Postmarketing surveillance studies have brought mixed results with either no [97,117,118] evidence or infrequent [119] evidence of abuse or dependence of zolpidem. It has to be noted that zolpidem is included (along with other benzodiazepine receptor agonists) in Schedule IV of the Convention on Psychotropic Substances of 1971 [302].…”