Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aims of this study are to (1) examine the medication use patterns of commonly prescribed hypnotics and the factors that were associated with the long-term and short-term use patterns among the elderly population in Taiwan; (2)investigate the associations of using hypnotics with the elderly patients' disease statuses, efficacy and safety, as well as its pharmacokinetic and pharmacogenetic characteristics;(3) determine the clinical, economic and humanistic outcomes of using hypnotics and the corresponding contributing factors for the elderly in Taiwan.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: China Medical University Hospital
• Collaborator: National Health Research Institutes, Taiwan
• Treatments: Alprazolam; Flunitrazepam; Hypnotics and Sedatives

Criteria

• Inclusion criteria

1. Patients who have received services in the outpatient departments in CMUH for at least six months persistently before the recruitment,

2. who are diagnosed with any types of sleep disorders within the outpatient medical records, using ICD-9 codes to identify.

3. who have been prescribed, for at least one week before the index date of observation, with one of the selected BZD or Z-drugs: estazolam, lorazepam, diazepam, alprazolam, flunitrazepam, zolpidem or zopiclone.

4. who agree to participate in this observation study and have signed informed consent

• Exclusion criteria

1. Those elderly patients who were diagnosed with cancers, seizures, specific psychiatric disorders (e.g., dementia, schizophrenia, panic disorder, alcohol withdrawal syndrome) and neurological disorders (e.g., Parkinson) in the baseline and during observation period