Residual effects of zopiclone 7.5 mg on cognition and driving performance in insomnia patients chronically using hypnotics - Insomniacs driving after use of zopiclone 7.5 mg

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002003-75-NL

Enrollment

Registered

2008-06-23

Start date

2008-07-11

Completion date

Unknown

Last updated

2024-01-08

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

Conditions

Primary insomnia MedDRA version: 9.1 Level: LLT Classification code 10036701 Term: Primary insomnia

Interventions

Trade Name: Imovane Product Name: zopiclone Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ZOPICLONE CAS Number: 43200802 Concentration unit: µg/ml microgram(s)/millilitre Pharmaceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 55 years or older 2. Possession of a valid driving license for 3 years or more (for >70 years: Possession of “Declaration of Appropriateness’ (in Dutch: Verklaring van Geschiktheid)) 3. Average driving experience of at least 3000 km per year over the last three years 4. Mentally and physically fit to drive 5. Good health, in the opinion of the medical supervisor, on the basis of a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood biochemistry, haematology, and serology tests, and urinalysis 6. For patients: complaints of insomnia 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: 1. History of drug or alcohol abuse 2. Chronic use of medication that affects driving performance (such as anti-epileptics, anti-psychotics, anti-depressants, anti-parkinsonian medication), except hypnotics 3. Drinking more than 6 cups of coffee per day 4. Drinking more than 21 glasses of alcohol per week 5. Smoking more than 10 cigarettes per day 6. BMI over 30 kg/m² 7. For patients: Sleep-Related Breathing Disorders; Circadian Rhythm Sleep Disorders; Sleep-Related Movement Disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether the residual effects of zopiclone 7.5 mg on driving performance in patients complaining of insomnia and who chronically use hypnotics differ from the effects in insomnia patients who do not regularly use hypnotics and from matched healthy controls.;Secondary Objective: To determine whether the residual effects of zopiclone 7.5 mg on cognitive and psychomotor performance in patients complaining of insomnia and who chronically use hypnotics differ from the effects in insomnia patients who do not regularly use hypnotics and from matched healthy controls.;Primary end point(s): The main study parameter is Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test.	—

Measure

Time frame

Main Objective: To determine whether the residual effects of zopiclone 7.5 mg on driving performance in patients complaining of insomnia and who chronically use hypnotics differ from the effects in insomnia patients who do not regularly use hypnotics and from matched healthy controls.;Secondary Objective: To determine whether the residual effects of zopiclone 7.5 mg on cognitive and psychomotor performance in patients complaining of insomnia and who chronically use hypnotics differ from the effects in insomnia patients who do not regularly use hypnotics and from matched healthy controls.;Primary end point(s): The main study parameter is Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test.

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Countries

Netherlands

Outcome results

None listed

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