The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.

NCT00235508 Phase 4 COMPLETED

To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 4
Status	COMPLETED
Enrolment	420
Start date	2005-06
Completion	2006-04

Conditions

• Insomnia
• Generalized Anxiety Disorder

Interventions

• Eszopiclone (Lunesta)

Primary outcomes

• The change from baseline in subjective sleep latency averaged over the double-blind treatment period. — 8 weeks

Countries

United States