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

NCT ID: NCT02648776

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-12-31

Brief 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.

Detailed Description

Aging is associated with the changes in the sleep structure, continuity, and timing while it also affects the elderly's physiological and psychological health statuses. Despite the fact that hypnotics are beneficial for the short-term management of insomnia, it is inconclusive about the risk and benefit ratios of long-term use for the elderly. The objectives of this study are to (1)examine the medication use patterns of prescribed hypnotics and the factors that were associated with the use patterns among the elderly population; (2)investigate the associations of using prescribed hypnotics with the elderly patients' disease statuses, efficacy and safety, as well as their pharmacokinetic and pharmacogenetic characteristics;(3)determine the clinical, economic and humanistic outcomes and corresponding factors of using hypnotics for long-term and short-term use in Taiwanese elderly.

This proposed study is the second part of a larger project that consists of two main phases across four years. The first part will include a retrospective database analysis to examine the medication use patterns for sleep disorders and corresponding outcomes using three data sets. Elderly patients aged 65 or older and who received hypnotics for insomnia will be selected from Taiwan's National Health Insurance Research Database, National Health Interview Survey and China Medical University Hospital (CMUH) in-house databases. Focus will be placed on benzodiazepines (BZD) and BZD-receptor specific non-BZD agents (Z-drugs), but Chinese traditional medication used for insomnia will also be examined.

This study is the second part of the larger project. The investigators will conduct a longitudinal, prospective, observational cohort study over a period of two years. The focus of this study is the use of hypnotic BZD and Z-drugs on elderly insomnia patients. The study cohorts include elderly patients, aged 65 years or older, who have received services in the outpatient departments of China Medical University Hospital, Taichung, Taiwan, and who have been prescribed with a selected BZD or Z-drug for insomnia for at least one week. A control group cohort will also be recruited. Each recruited patient will be monitored and evaluated periodically for at least one year. Economic, clinical, and humanistic outcomes, as well as adherence to the hypnotics will be assessed and monitored. Safety and tolerability will be assessed by occurrence of adverse drug reactions. Pharmacokinetic properties and genotyping patterns will be also be evaluated using snapshot blood sampling after the 6th month of enrollment in the study. The clinical and humanistic outcomes measures will include changes in insomnia status, functional status changes, depression status, as well as over-all well-being using EuroQol 5D. Economic evaluation will compare total insurance and out-of-pocket expenses at baseline and at 12 months follow up.

Conditions

Sleep Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Estazolam

Exposure to sedative-hypnotic drugs; Patients who have taken estazolam for at least one week before the first date of enrollment

Exposure to sedative-hypnotic drugs

Intervention Type: DRUG

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Lorazepam

Exposure to sedative-hypnotic drugs; Patients who have taken lorazepam for at least one week before the first date of enrollment

Exposure to sedative-hypnotic drugs

Intervention Type: DRUG

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Diazepam

Exposure to sedative-hypnotic drugs; Patients who have taken Diazepam for at least one week before the first date of enrollment

Exposure to sedative-hypnotic drugs

Intervention Type: DRUG

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Alprazolam

Exposure to sedative-hypnotic drugs; Patients who have taken Alprazolam for at least one week before the first date of enrollment

Exposure to sedative-hypnotic drugs

Intervention Type: DRUG

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Flunitrazepam

Exposure to sedative-hypnotic drugs; Patients who have taken Flunitrazepam for at least one week before the first date of enrollment

Exposure to sedative-hypnotic drugs

Intervention Type: DRUG

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Zolpidem

Exposure to sedative-hypnotic drugs; Patients who have taken Zolpidem for at least one week before the first date of enrollment

Exposure to sedative-hypnotic drugs

Intervention Type: DRUG

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Zopiclone

Exposure to sedative-hypnotic drugs; Patients who have taken Zopiclone for at least one week before the first date of enrollment

Exposure to sedative-hypnotic drugs

Intervention Type: DRUG

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Control Group

Patients not taking any of the included or any other anxiety-hypnotic agents

No interventions assigned to this group

Interventions

Exposure to sedative-hypnotic drugs

These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.

Intervention Type: DRUG

Other Intervention Names

Medication Exposure

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsiang-Wen Lin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsiang-Wen Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Pharmacist, Associate Professor

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

DMR101-IRB1-083

Identifier Type: -

Identifier Source: org_study_id