Vissers Frans H J A, Knipschild Paul G, Crebolder Harry F J M
Department of General Practice, Maastricht University, P.O. Box 616, Maastricht, 6200 MD, The Netherlands.
Pharm World Sci. 2007 Dec;29(6):641-6. doi: 10.1007/s11096-007-9118-y. Epub 2007 Jul 3.
To find out if administration of melatonin facilitates discontinuation of benzodiazepine (BD) therapy in patients with insomnia.
A placebo controlled trial in nine general practices in the Netherlands. Long-term users of benzodiazepines were asked by their GP to participate in a discontinuation program in combination with melatonin or placebo. The intervention and follow-up period lasted one year. During this period participants received four questionnaires about their use of sleeping medication and several health instruments. The urine of all participants was tested for the presence of benzodiazepines, as proof of the discontinuation.
The discontinuation of benzodiazepine use measured by questionnaires and urine samples at three assessment points.
A total of 503 long-term users were selected by the GPs, of whom 38 patients (16M/22F) participated. After one year 40% had stopped their benzodiazepine use, both in the intervention group on melatonin and in the placebo control group. Comparing stoppers and non-stoppers did not reveal significant differences in benzodiazepine use, or awareness of problematic use.
Our findings do not conclusively indicate that melatonin is helpful for the discontinuation of the use of benzodiazepines, but the average dose of benzodiazepines in the group was low. Further investigation is necessary, with special attention to the possible influence of the daily dose on the facilitation effect of melatonin.
探究褪黑素的使用是否有助于失眠患者停用苯二氮䓬类药物（BD）治疗。
在荷兰的九个普通诊所进行的一项安慰剂对照试验。苯二氮䓬类药物的长期使用者被其全科医生邀请参加一项结合褪黑素或安慰剂的停药计划。干预和随访期持续一年。在此期间，参与者收到了四份关于其使用睡眠药物的问卷以及几份健康状况调查问卷。对所有参与者的尿液进行检测，以确定是否存在苯二氮䓬类药物，作为停药的证据。
通过在三个评估点的问卷和尿液样本测量苯二氮䓬类药物的停用情况。
全科医生共挑选出503名长期使用者，其中38名患者（16名男性/22名女性）参与。一年后，褪黑素干预组和安慰剂对照组中均有40%的患者停止使用苯二氮䓬类药物。比较停药者和未停药者，在苯二氮䓬类药物使用或对问题使用的认知方面未发现显著差异。
我们的研究结果并未确凿表明褪黑素有助于停用苯二氮䓬类药物，但该组中苯二氮䓬类药物的平均剂量较低。有必要进行进一步研究，特别关注每日剂量对褪黑素促进作用的可能影响。
