Abstract

Background: Benzodiazepines (BZD) and benzodiazepine receptor agonists (zolpidem, zaleplon, zopiclone, altogether Z-drugs) are most commonly prescribed for the treatment of insomnia.  However, long-term use of BZD/Z-drugs is associated with major adverse events including, but not limited to, falls and fractures, domestic and traffic accidents, confusion, cognitive impairment, Alzheimer's disease and cancer.  The prolonged use of these drugs is thought to be related to severe withdrawal symptoms and potential dependency.  The chronic and extensive use of BZD/Z drugs has become a public health issue and has led to multiple campaigns to reduce both prescription and consumption of BZD/Z-drugs.  Prolonged-release (PR) melatonin is the first of a new class of melatonin receptor agonist drugs that has demonstrated clinically relevant efficacy on improving quality of sleep and morning alertness, with a good safety profile. Objective: This study aimed to analyse and evaluate the impact of anti-BZD/Z-drugs campaigns and the availability of alternative pharmacotherapy (PR-melatonin) on the consumption of BZD and Z-drugs in several European countries. Methods: Annual sales data from nine European countries (Finland, Norway, Denmark, Sweden, Greece, France, the Netherlands, Spain and the United Kingdom) were extracted from the IMS sales database and analysed to determine whether trends in use of these treatment options were attributed to campaigns and/or availability and affordability of safer alternatives on the market. Results: Campaigns aiming to reduce the use of BZD/Z-drugs failed when they were not associated with the availability and market uptake of PR-melatonin (Circadin, Neurim Pharmaceuticals).  The reimbursement of PR-melatonin supports better penetration rates and a higher reduction in sales for BZD/Z-drugs.