Department of Sleep Medicine, St. Hedwig-Krankenhaus, Berlin, Germany.
Expert Opin Pharmacother. 2012 Jan;13(1):9-16. doi: 10.1517/14656566.2012.638284. Epub 2011 Nov 22.
Prolonged-release (PR) melatonin is approved in Europe for the treatment of insomnia in patients aged 55 years and above. The objective of the study was to describe its prescription patterns and its impact on hypnotics use in routine clinical practice.
This is a retrospective study analyzing PR melatonin prescription data from a German longitudinal database (IMS(®) Disease Analyzer). All patients initiating PR melatonin over the 10 months after approval (April 2008 - February 2009) were included. Patients were classified according to their use of hypnotic benzodiazepines or benzodiazepine-like drugs (BZD/Z) in the 3-month period before and after PR melatonin initiation.
Of the 512 eligible patients, 380 (74%) were aged ≥ 55 years, 344 (67%) women and 112 (22%) previous BZD/Z users. Most of the latter (79/99, 79.8%) had used BZD/Z for at least 180 days. Approximately one-third (35/112, 31%) discontinued BZD/Z after PR melatonin initiation, and the BZD/Z discontinuation rate was higher in patients receiving two or three PR melatonin prescriptions than in patients receiving only one prescription (10/24 = 42% vs 25/88 = 28%, p = 0.21). Of the 400 patients without prior BZD/Z use, 39 (10%) received BZD/Z during the follow-up.
Based on the observed 31% discontinuation rate, PR melatonin may help to facilitate BZD/Z discontinuation in older insomniacs.
在欧洲，延长释放型（PR）褪黑素被批准用于治疗 55 岁及以上患者的失眠症。本研究的目的是描述其处方模式及其对常规临床实践中催眠药物使用的影响。
这是一项回顾性研究，分析了德国纵向数据库（IMS（®）疾病分析器）中 PR 褪黑素的处方数据。所有在批准后 10 个月内（2008 年 4 月至 2009 年 2 月）开始使用 PR 褪黑素的患者均被纳入研究。根据患者在开始使用 PR 褪黑素前后 3 个月内使用催眠苯二氮䓬类或苯二氮䓬类样药物（BZD/Z）的情况对患者进行分类。
在 512 名符合条件的患者中，380 名（74%）年龄≥55 岁，344 名（67%）为女性，112 名（22%）为既往 BZD/Z 使用者。其中大多数（79/99，79.8%）至少使用过 BZD/Z 180 天。大约三分之一（35/112，31%）在开始使用 PR 褪黑素后停止使用 BZD/Z，接受 2 或 3 次 PR 褪黑素处方的患者比仅接受 1 次处方的患者 BZD/Z 停药率更高（24/24 = 42% vs 88/88 = 28%，p = 0.21）。在 400 名没有使用过 BZD/Z 的患者中，有 39 名（10%）在随访期间使用了 BZD/Z。
根据观察到的 31%的停药率，PR 褪黑素可能有助于促进老年失眠症患者停止使用 BZD/Z。
