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Drug related problems (DRP) of non-prescription hypnotics and sedatives – a non-interventional, pharmacy-based cross-sectional study

Drug related problems (DRP) of non-prescription hypnotics and sedatives – a non-interventional, pharmacy-based cross-sectional study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00023104
Enrollment
2000
Registered
2021-01-08
Start date
2021-05-01
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F51.0 G47.0

Interventions

Group 1: Patients with difficulty falling asleep and/or staying asleep are surveyed in a fixed one-time questionnaire.

Sponsors

Johannes Gutenberg-Universität Mainz; Institut für pharmazeutische und biomedizinische Wissenschaften
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - age = 18 years - intake of a non-prescription sleep aid at the point of questioning - ability to complete the questionnaire independently - ability to understand German adequately, both spoken and written - presence of a written declaration of consent

Exclusion criteria

Exclusion criteria: - inclusion criteria are not accomplished - refusal of declaration of con-sent - insufficient ability to recognize the consequences of participating in the study - first-time application of sleep aid - purchase of compound for another person

Design outcomes

Primary

MeasureTime frame
Medication errors: Examination of whether the patient is using the non-prescription sleep aid in accordance with the recommendations underlying the package information leaflet. This refers to contraindications, the recommended duration of use and the indicated dosage. Rare side effects: Examination of whether rare, previously unknown side effects occur when the preparations are used as intended. Other drug-related problems: Examination for side effects as a result of improper use. Special attention is paid here to whether a hangover or rebound effect, a development of tolerance, the occurrence of withdrawal symptoms as well as the development of physical and / or psychological dependency can be observed as a result of the use of sleep aids.

Secondary

MeasureTime frame
Patient knowledge and role of the pharmacist/PTA: Examination of whether the patient is informed about the known side effects, interactions, contraindications and warnings as well as the recommended dosage of his/her sleep aid. Furthermore, it is examined where the patient got his knowledge from and to what extent this affects the self-medication. Individual-related evaluation: Examination of whether differences can be determined due to the various person-related influences (e.g. age, gender, occupation) when evaluating the characteristics to be collected. Pharmacy-related evaluation: Examination of whether differences can be identified in the evaluation of the characteristics to be collected, depending on whether the patient is a customer of a community or a mail-order pharmacy.

Countries

Germany

Contacts

Public ContactVanessa Efinger

Johannes Gutenberg-Universität Mainz; Institut für pharmazeutische und biomedizinische Wissenschaften

vefinger@uni-mainz.de+49 6131 39-23063

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026