Benzodiazepine discontinuation with prolonged-release melatonin: hints from a German longitudinal prescription database

Expert Opin Pharmacother. 2012 Jan;13(1):9-16. doi: 10.1517/14656566.2012.638284. Epub 2011 Nov 22.


Objective: 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.

Research design and methods: 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.

Results: 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.

Conclusions: Based on the observed 31% discontinuation rate, PR melatonin may help to facilitate BZD/Z discontinuation in older insomniacs.

MeSH terms

  • Aged
  • Benzodiazepines / therapeutic use*
  • Delayed-Action Preparations / therapeutic use
  • Female
  • Germany
  • Humans
  • Hypnotics and Sedatives / therapeutic use*
  • Male
  • Melatonin / therapeutic use*
  • Middle Aged
  • Retrospective Studies
  • Sleep Initiation and Maintenance Disorders / drug therapy*


  • Delayed-Action Preparations
  • Hypnotics and Sedatives
  • Benzodiazepines
  • Melatonin