Efficacy and Safety Assessment of ZOlpidem (Stilnox CR) in Patients With Chronic insomNIA

Sanofi

Status and phase: Completed; Phase 4

Conditions: Sleep Disorders

Treatments: Drug: ZOLPIDEM SL800750

Study type: Interventional

Funder types: Industry

Identifiers

NCT01024192

ZOLPI_L_04134

Details and patient eligibility

About

Primary Objective:

To evaluate the efficacy and safety of the use of Stilnox CR in Mexican patients with chronic insomnia at the prescription conditions of daily practice

Secondary Objective:

To evaluate the satisfaction of the patient with chronic insomnia with Stilnox CR over an as needed basis.

Enrollment: 135 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary insomnia diagnosis (difficulty for initiating sleep, or maintaining sleep to wake up to early in the morning, or to present a restless sleep) which causes clinically significant disturbances in the areas of social, work functioning or other important areas

Exclusion criteria

• Serious, severe and/or acute respiratory impairment
• Severe liver impairment
• Hypersensitivity to the formulation components or to some of its active metabolites
• Pregnant or breast-feeding women Patients with important associated disorders in SNC and specially psychotic disorders
• Patients with the probability of using alcoholic beverages concomitantly (as a precaution measure)
• Chronic use of benzodiazepines

Moreover, in order to follow the international regulations in terms of the use and handling of hypnotic compounds, and to guarantee the appropriate study performance, no patients with one or more of the following characteristics should be included:

• Patients who cannot comply to follow-up
• Patients who have any drug abuse problem
• Individuals who work changing night shifts or with pathological snoring
• Presence (or suspicion) of sleep apnea, periodical legs movements or restless legs syndrome

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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135 participants in 1 patient group

1

Experimental group

Description:

Zolpidem 12.5mg tablet at bed time during 12 weeks

Treatment:

Drug: ZOLPIDEM SL800750