Benzodiazepine discontinuation with prolonged-release melatonin: hints from a German longitudinal prescription database
Abstract
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.
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The effectiveness of extended-release melatonin as an adjunctive agent for deprescribing BZDs and Z-drugs remains controversial; some studies reported beneficial effects, others found no advantage compared to placebo.
“Its effectiveness remains controversial: while some studies 84 85 have reported beneficial effects, others 86 have found no advantage compared to placebo.”
From Z-drug abuse and dependence: Clinical guideline of the Brazilian Academy of Neurology for diagnosis and management (2025) · cites this paper as [85]
Reported rates of successful discontinuation using 2 mg of prolonged-release melatonin ranged from 31 to 46.5%.
“The reported rates of successful discontinuation using 2 mg of prolonged-release melatonin ranged from 31 to 46.5%. 84 85 86”
From Z-drug abuse and dependence: Clinical guideline of the Brazilian Academy of Neurology for diagnosis and management (2025) · cites this paper as [85]
There is limited clinical evidence to confirm the efficacy of add-on pharmacological approaches for Z-drug deprescription, but expert opinion supports their use.
“Although there is limited clinical evidence 84 85 86 90 91 97 to confirm the efficacy of these approaches, expert opinion supports their use (particularly when guided by a comprehensive evaluation of patient comorbidities) as a means to facilitate Z-drug withdrawal.”
From Z-drug abuse and dependence: Clinical guideline of the Brazilian Academy of Neurology for diagnosis and management (2025) · cites this paper as [85]
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- Authors
- Kunz, D., Bineau, S., Maman, K., Milea, D., & Toumi, M.
- Affiliations
- St. Hedwig-Krankenhaus (DE)
- Creativ-Ceutical (France) (FR)
- Lyon 1 Université (FR)
- Venue
- Expert Opinion on Pharmacotherapy
- Publisher
- Informa Healthcare
- Published
- 2011-11-22
- Volume
- 13
- Issue
- 1
- Pages
- 9-16
- ISSN
- 1465-6566 (ISSN-L)
- 1744-7666
- OpenAlex
- W2165322847
- Cited by
- 37
- References
- 23
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 1 · 2022: 4 · 2021: 2 · 2020: 1 · 2018: 3 · 2016: 4 · 2015: 4 · 2014: 3 · 2013: 4 · 2012: 8
- FWCI
- 6.16
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Expert Opinion on Pharmacotherapy (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Circadian rhythm and melatonin
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- prolonged-release melatonin, benzodiazepine discontinuation, benzodiazepine-like drugs, insomnia, older adults, drug substitution
- MeSH terms
- Aged, Benzodiazepines, Delayed-Action Preparations, Female, Germany, Humans, Hypnotics and Sedatives, Sleep Initiation and Maintenance Disorders, Male, Melatonin, Middle Aged, Retrospective Studies
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