Efficacy and Safety of Zolpidem-MR Administered Over a Long Term Period as Needed for Insomnia (ZOLONG)

Completed · Phase 3

Conditions studied: Sleep Initiation and Maintenance Disorders

In brief

The primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-MR 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia. Secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-MR 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.

Key facts

Study ID

NCT00425243

Run by

Sanofi

People needed

1025

Starts

2004-08-01

Expected to finish

2006-01-01

Last updated by the study team

2009-04-06

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients with chronic primary insomnia
• The investigator will evaluate whether there are other reasons why a patient may not participate.

Where it is running

• Sanofi-Aventis — Malvern, Pennsylvania, United States

Full record on ClinicalTrials.gov

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