Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo

Completed · Phase 4

Conditions studied: Insomnia

In brief

Investigation of Psychomotor and Cognitive Residual Effects of Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg and Eszopiclone 3 mg Compared to Placebo in Healthy Young Volunteers, Using Flurazepam 30 mg as an External Comparator

Key facts

Study ID

NCT00283790

Run by

Sanofi

People needed

36

Starts

2006-01-01

Expected to finish

2006-04-01

Last updated by the study team

2008-04-03

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female subjects aged between 18 and 45 years.
• Usual bedtime between 21:00 and 01:00
• Body mass index (BMI) between 18 and 32 kg/m2.
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and a complete physical examination).
• Laboratory tests within the normal range of the laboratory (hematology, biochemistry, urinalysis) or within the acceptable range per agreement between investigator and sponsor.
• Negative urine pregnancy test for females (to be confirmed at screening and prior to every dose of study medication)
• Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or they must be surgically sterilized or post-menopausal. If abstinent, women must agree to use double-barrier contraception throughout the study period should they become sexually active.
• Written informed consent signed

You may not qualify if…

• Presence or history of clinically relevant cardiovascular, hepatic, pulmonary, gastrointestinal, renal, metabolic, hematological, neurologic or psychiatric disease, any acute infectious disease or signs of acute illness, and myasthenia gravis
• Any disorder initiating or maintaining sleep such as Obstructive Sleep Apnea, Insomnia, Restless Leg Syndrome, Periodic Limb Movement Disorder, Circadian Rhythm Disorder and Parasomnia
• Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
• Symptomatic hypotension, whatever the decrease of blood pressure, or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position.
• History of hypersensitivity to zolpidem, eszopiclone, or flurazepam.
• Use of any medication within one month prior to study start, except occasional use of acetaminophen or ibuprofen.
• History of drug abuse during prior twelve months
• Excessive consumption of xanthine-based beverages (more than 6 cups or glasses per day) or unable to stop consumption during the overnight study periods.
• Inability to communicate or cooperate with the investigator because of a language problem, poor mental status, or impaired cerebral status.
• Positive results of urine drug screen testing (amphetamines, benzodiazepines, cannabis, barbiturates, cocaine, opiates, antidepressants).
• Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins)
• Current use of tobacco products including cigarettes, cigars, pipes, or chewing tobacco, current participation in a smoking cessation program, or discontinuation of smoking within 3 months prior to screening
• Subject is currently participating in another clinical trial with an investigation product/device (or within 30 days of screening).

Where it is running

• Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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