New Insights Into the Management of Insomnia

DRESDEN, Germany, Oct. 7, 1999--During the Third Congress of the World Federation of Sleep Research Societies (WFSRS) from October 5th to 9th 1999, Professors Eduard Estivill (Institut Universatari Dexeus, Barcelona, Spain), Göran Hajak (Georg-August Universität, Göttingen, Germany) and Raymond Cluydts (Sleep Wake Disorders Centre, University Hospital, Antwerp, Belgium) held a press conference to present new information on the epidemiology of insomnia in Europe, the results of the latest clinical trials conducted with zolpidem and the ways in which these heralded a new approach to the treatment of insomniac patients.

Professor Estivill reviewed the data collected in four European countries (France, Germany, Spain and England) through interviews conducted with approximately 2,000 people in each country. The survey revealed a mean prevalence of insomnia ranging from 30% to 46%, in accordance with previous studies. It also provided valuable insights into the attitude of insomniacs towards this disorder and its treatment.

First of all, the survey revealed that a considerable proportion of insomniacs, despite being fully aware of the adverse effects of their sleep disorder on their daily activities, had taken no medical steps to remedy this problem. Only 32% of the insomniacs questioned in this survey declared that they had consulted a physician, a further 10% had sought the advice of their pharmacist to try to find a solution to their problems and 37% had taken no action at all. Detailed analysis of the reasons why these patients had not seen fit to consult their physician revealed two principal explanations. In the first place, many of them did not " feel at ease with the idea of taking sleeping pills ", a statement reflecting their fear of becoming dependent on the medication taken. Secondly, most of them did not consider insomnia to be a sufficient motive for seeking a medical opinion, despite its repercussions on their daily activities.

Another very interesting revelation was that 60% of the insomniacs interviewed declared that they did not suffer from sleeping problems every night, confirming the fluctuating nature of this disorder. Analysis of the most frequently reported symptoms revealed that insomnia is for most of the time multisymptomatic, confirming the suspicions of the medical community. The main symptoms are difficulty in falling asleep, waking up during the night, feeling that sleep was not as refreshing as it should be and too early awakening.

When insomniacs were questioned about how they used prescribed medication or self-medication remedies purchased in a pharmacy, a substantial proportion declared that they took sleeping pills when they felt they needed to. Close to 50% of the insomniacs interviewed reported that they did not take their medication every evening.

Taken as whole, these results highlight the necessity of reinstating the patient at the heart of the debate on insomnia and its treatment. The picture portrayed by the survey, revealing a clear under-use of medical resources by the majority of insomniacs and a high prevalence of " personalised " modes of treatment, highlights the urgency of developing new approaches to the use of sleeping pills capable of reconciling public health constraints with provision of an optimal service to the patient.

Professor R. Cluydts (Belgium) and Professor G. Hajak (Germany) presented and discussed recent data obtained in a set of studies on zolpidem designed to meet international consensus guidelines recommending non-continuous use of hypnotics in chronic insomnia. To date, no clinical evaluation with any medication on such alternative treatment regimens has been reported. The primary goals are to prevent psychological dependence on hypnotics and to rationalise their usage on an " as needed " basis, i.e. the patient should only take his/her sleeping pill when really necessary. Such non-continuous schedules of administration of zolpidem were studied in four double-blind studies conducted on more than 1,200 insomniac patients in Europe and in the USA.

The main results were as follows:
  • The prescription of zolpidem on an " as needed " basis is feasible and leads to a decrease in drug consumption of about 30% compared to intake on a nightly basis.
  • No significant changes in the safety profile were noted and, in particular, no rebound insomnia was seen when the patient either switched to placebo or stopped taking zolpidem.
  • The efficacy of the " as needed " schedule was not perceived to be significantly different from that of the continuous one.

Through this extensive clinical programme, zolpidem is the first hypnotic to demonstrate its efficacy and safety of use in insomniac patients on an " as needed " basis. Zolpidem therefore provides patients with a satisfactory solution when continuous use of a hypnotic is expected. In addition, it appears to be an appropriate treatment for patients not taking any sleeping pills because of the fear of dependence.

Zolpidem, marketed under the tradenames STILNOX® and AMBIEN® (in the USA), was first launched in 1988 and is currently the world's leading hypnotic agent.

Through the very extensive research programme already conducted on zolpidem, Sanofi-Synthelabo continues to further its commitment to optimise the management of patients suffering from insomnia.

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Posted: June 2004

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