A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

Transcept Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Insomnia

Treatments: Drug: zolpidem tartrate sublingual tablet; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00466193

ZI-12

Details and patient eligibility

About

The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.

Enrollment: 295 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with history of sleeplessness

Exclusion criteria

• Allergic to investigational drug
• Any conditions and medications that may interfere with study drug evaluation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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295 participants in 2 patient groups, including a placebo group

Zolpidem 3.5mg

Experimental group

Treatment:

Drug: zolpidem tartrate sublingual tablet

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo