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

T

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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