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Journal of Psychopharmacology
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*ZOLPIDEM TARTRATE
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The safety and tolerability of zolpidem — an update

G. Darcourt

D. Pringuey

Department of Psychiatry, Pavillon J, CHU Pasteur, BP 69, 06002 Nice

D. Sallière

Synthélabo Recherche, BP 110, 31 avenue PaulVaillant-Couturier, 92225 Bagneux

J. Lavoisy

Synthélabo Groupe, BP 82, 22 avenue Galilée, 92352 Le Plessis-Robinson, France

Zolpidem belongs to a new class of hypnotic agents, chemically distinct from the pre-existing ones, and has a unique neuropharmacological profile. It induces sedative/hypnotic effects in rodents at doses much lower than those for anticonvulsant and myorelaxant activities. Clinically, zolpidem is indicated for the short term treatment of insomnia. It has a short half-life (2.4 h), with no active metabolite, and does not accumulate during repeated administration. The pharmacokinetic profile associated with the absence of active metabolites is consistent with the short duration of action and absence of residual effects that have been observed. Polysomnographic experience indicates that zolpidem induces a sleep pattern which is similar to that of physiological sleep, and which produces either no or only minimal effects on sleep architecture after abrupt discontinuation. Aspects of the general safety of zolpidem have been studied in data obtained from healthy volunteers and patients, both adult and elderly, during its clinical development and in post-marketing experience. Zolpidem appears to be well-tolerated in adults and in the elderly, when administered in accordance with prescribing instructions. The available data indicate that, in these circumstances, the risk of abuse or dependence is minimal.

Key Words: benzodiazepines • hypnotic • insomnia • imidazopyridines • zolpidem

Journal of Psychopharmacology, Vol. 13, No. 1, 81-93 (1999)
DOI: 10.1177/026988119901300109


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