Study identification

EU PAS number

EUPAS5106

Study ID

14148

Official title and acronym

Prescribing of zolpidem in the primary care setting in France, Germany and the UK during 2012. (Prescribing of zolpidem in IMS Germany/France/UK)

DARWIN EU® study

No

Study countries

France
Germany
United Kingdom

Study description

The present study aims to describe the extent and patterns of prescription of zolpidem in the primary care setting in three large EU countries in 2012 in line with the scope of an Article 31 referral. This has been done using the EMA’s in-house IMS Health databases.The study includes patients from UK, Germany and France and for these patients the prevalence of zolpidem use in 2012 is stratified by gender and age. The prevalence of low strength (5 mg) and high strength (10 mg) prescribing and by different daily doses prescribed is also reported. In addition new users in 2011 has been characterised and the percentage starting at low/high strength and different daily doses is reported. These new users are followed up and the extent of use 3-6 months after the first prescription is studied.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Kristian Svendsen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

There was no specific funding for the project which was conducted using EMA resources.
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable