A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: zolpidem tartrate sublingual tablet 3.5mg; zolpidem tartrate sublingual tablet 1.75mg; Placebo
Intervention description: Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.; Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Intervention MeSH terms: Zolpidem
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Insomnia

Summary:

      The purpose of this study is to evaluate sleep onset following administration of Transcept
      zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Insomnia as defined by DSM-IV criteria and supported by subject diary

          -  Male or female between the ages of 18-64 years

          -  Body mass index (BMI) between 18-34 kg/m^2

          -  Females of childbearing potential must use a medically acceptable method of
             contraception

          -  Capable of understanding and willing to comply with study procedures and has provided
             informed consent

        Exclusion Criteria:

          -  Females who are pregnant, breast-feeding or have a positive pregnancy test

          -  Any circadian rhythm disorder including planned travel across several time zones
             during the study period

          -  Known hypersensitivity to Zolpidem

          -  Has performed regular shift work with the past several months prior to screening

          -  An acute clinically significant illness or surgery as determined by the PI within 30
             days of screening

          -  Patients that have used any central nervous system (CNS) medication or other
             medication known to impact the sleep/wake cycle

          -  A history of psychiatric disorder as defined by DSM-IV

          -  A history of drug addiction or alcohol abuse

          -  Any current significant disease, unless adequately controlled with a protocol allowed
             medication

          -  Known history of HIV or Hepatitis B or C

          -  Patients who have received an investigational drug within several months of screening