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

Evaluation of the Long-Term Efficacy and Safety of Zolpidem-MR 12.5 mg Compared to Placebo, When Both Are Administered Over a Long-Term Period as Needed, in Patients With Chronic Primary Insomnia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00425243

Enrollment

1025

Registered

2007-01-22

Start date

2004-08-31

Completion date

2006-01-31

Last updated

2009-04-06

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

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

primary insomnia, chronic insomnia

Brief summary

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.

Interventions

DRUGzolpidem-MR (SL800750)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.	—

Secondary

Measure	Time frame
Main secondary variables are the Clinical Global Impression (CGI) improvement item and to items 2, 3, and 4 of the PGI scale at week 12.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026