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Órgano Oficial del Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz

2001, Number 1

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Salud Mental 2001; 24 (1)

El efecto del zolpidem en los pacientes con insomnio de corta evolución

Álvarez RJM, Gutiérrez AJ, Rosales J, Díaz MA, Lablache B C

Language: Spanish
References: 54
Page: 33-42
PDF size: 150.28 Kb.


ABSTRACT

The wake-sleep cycle disorders are considered as health problems in a high percentage of the population. Insomnia is the more frequent sleep disorder usually observed by the general practitioner, since it is accepted that its prevalence in the community is approximately 33%. Insomnia and the associated daytime fatigue also provoke discomforts that frequently are clinically meaningful because they are associated to drowsiness, anxiety, and lack of concentration and memory. These disorders induce social and occupational deterioration or alterations in other important areas of the daily activity of the individuals. The initial therapeutic approximation to the patient with insomnia should be that of continually motivating him to acquire good sleep habits. Unfortunately, in some patients having good hygienic sleep habits is not sufficient, therefore hypnotic drugs have to be prescribed during a short time in order to balance the dream/wake cycle. Benzodiazepines (BDZ) are among the available pharmacological agents usually prescribed. Unfortunately, when BDZ are administered, symptoms of tolerance or physical dependency may appear. Recently, other compounds were synthesized, such as zolpidem (ZPM), an sleep inductor with a novel structure and a particular neuropharmacological profile. This work was designed to show the clinical characteristics of ZPM, and compare them with those of a BDZ, the flunitrazepam (FNZ), in a group of patients with insomnia. This multicentric study includes 100 ambulatory patients between 18 and 65 years, with a clinical diagnosis of primary insomnia. The evaluation of the treatment was accomplished through the application of Leeds Sleep Evaluation Questionnaire (QSEL), and the St. Mary´s Hospital Evaluation Questionnaire (SQSMH). Additionally, a Clinical Global Impression Scale (CGIS) and the evaluation of the safety profile of drugs were included. The obtained variables were analyzed by using a two ways analysis of variance and a significant difference was observed with a p<0.05 level. The compared groups did not show any statistical differences. Within the QSEL, the identified factors: get to sleep (GTS) quality of sleep (QOS), awake from sleep (AFS) and behavior from waking (BFW) showed a reduction in the mean values with respect to the initial values in both ZPM (differences of -135.42; -98.40; -48.48; -47.86) and FNZ (-123.04; -91.42; -69.94; -76.60). In the SQSMH the identified factors: sleep latency (SL), total sleep duration (TSD), sleep quality (SQ) and satisfactory sleep (SS) were also modified after treatment. SL decreased with ZPM (-1:24 h) and FNZ (-1:26 h); TSD increased with respect to the initial values with ZPM (2:21 h) and FNZ (2:12 h), the SQ also increased with ZPM (2:25 h) and FNZ (2:13 h). The SS was evaluated by the percentage of patients reporting morning alertness and full alertness, specially with ZPM (62% vs 36% with FNZ). Thirty two collateral events were reported with ZPM, and 43 with FNZ. The drowsiness and the dizziness were the most frequent collateral events with FNZ (33 vs 13 with ZPM). The intensity of all collateral events was from mild to moderate. No patient required any change of medication during the study due to any serious collateral events. Insomnia and the associated daytime fatigue provoke discomfort that is frequently clinically meaningful because of being associated to drowsiness, anxiety, and to concentration and memory problems. These disorders induce social and occupational deterioration and alterations of other important areas of the individual’s daily activity. Hypnotic drugs and inductors of sleep are the most frequent treatments prescribed for managing insomnia, therefore it is important to evaluate the impact they have on the quality and quantity of sleep and on daytime performance. In the present study validated instruments were applied for the clinical evaluation of the safety and efficiency profile of hypnotic drugs, such as ZPM, a non BDZ drug, and the FNZ, a derivative of BDZ, on insomnia, in a population of adult youths. In the SEQL the studied factors showed an important decrease with respect to pre-drug values. The patients included in the study reported difficulty for going to sleep, a poor sleep quality, difficult awakening and morning drowsiness, whereas in the post drug period they changed to easy sleep, an improvement in the quality of sleep and an ostensible decrease in their difficult awakening and in their morning drowsiness. In the SMHSQ the effect of ZPM and FNZ in the studied factors was observed: both treatments decrease SL, increase TSD, SQ and SS, with the advantage of ZPM in the quality of awakening and diurnal performance. No differences were found between groups in the CGIS. Data showed that both treatments significantly reduced insomnia. The therapeutic dose of ZPM used in this study did not provoke morning drowsiness nor daytime alterations, which are clearly observed with FNZ. It is important to notice that one of the more frequently observed collateral effects following hypnotic treatment is the impact on daytime performa nce, due to drowsiness. In this study drowsiness was twice as frequent with FNZ than with ZPM. It may be concluded that ZPM and FNZ are adequate for the therapeutic management of sleep dysfunction, although ZPM seems to be a more selective hypnotic agent with less collateral events related to the CNS. ZPM is one of the more extensively used hypnotic agents in clinical studies as well as in the daily practice. Other aspects, such as rebound insomnia, tolerance effects or withdrawal syndrome were not followed up in this study, therefore further studies are needed, but the comparison between ZPM and a classic hypnotic drug, sugests that ZPM offers several benefits, particularly with respect to the pharmaco-clinical profile of security.


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