Controlled-release melatonin in fast withdrawal of temazepam, zopiclone or zolpidem in elderly persons with insomnia - Satauni

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006795-30-FI

Enrollment

Registered

2008-10-31

Start date

2009-01-16

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Individuals over 55 years with primary insomnia and DDD need of temazepam, zopiclone or zolpidem MedDRA version: 9.1 Level: LLT Classification code 10036701 Term: Primary insomnia

Interventions

Trade Name: Circadin Product Name: Circadin Product Code: N05CH01 Pharmaceutical Form: Tablet CAS Number: 73314 Other descriptive name: MELATONIN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Over 55 y. primary insomnia, DDD need temazepam,zopiclone or zolpidem Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Individuals using antipsycotics or antiepileptics or other benzodiazepines Severe anxiety, psychiatric or neurologic diseases Alcohol or drug abuse Autoimmune diseases or galactosaemia Smoking more than 10 cigarettes Disallowed medicins: fluvoxaminemaleat, 5-and 8-metoxypsoralen, cimetidin, fluorokinolones, carbamazepin, rifampicin, varfarin

Design outcomes

Primary

Measure	Time frame
Main Objective: Individuals over 55 years with primary insomnia and DDD need of temazepam, zopiclone or zolpidem;Secondary Objective: No;Primary end point(s): The withdrawal of temazepam,zopiclone or zolpidem. Complete discontinuation of these drugs	—

Countries

Finland

Outcome results

None listed

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