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

• Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes.
• Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period.
• Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire.
• Subjective Sleep Quality Rating [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
• Subjective Level of Refreshed Sleep [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
• Subjective Ability to Function [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.
• Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period.
• Subjective Sleep Onset Latency After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.
• Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period.
• Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period.
• Polysomnography Number of Awakenings After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ] [ Designated as safety issue: No ]
  Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period.

• Average total sleep time [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]
• Average sleep efficiency [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]
• Sleep quality rating [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]
• Average sleep onset latency [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]
• Average subjective total sleep time [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]

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

• Drug: zolpidem tartrate sublingual tablet 3.5mg
  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.
  Other Name: Intermezzo®
• Drug: zolpidem tartrate sublingual tablet 1.75mg
  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.
  Other Name: Intermezzo®
• Drug: Placebo
  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.

• Experimental: placebo/zolpidem 3.5/zolpidem 1.75
  Interventions:

  • Drug: zolpidem tartrate sublingual tablet 3.5mg
  • Drug: zolpidem tartrate sublingual tablet 1.75mg
  • Drug: Placebo
• Experimental: placebo/zolpidem 1.75/zolpidem 3.5
  Interventions:

  • Drug: zolpidem tartrate sublingual tablet 3.5mg
  • Drug: zolpidem tartrate sublingual tablet 1.75mg
  • Drug: Placebo
• Experimental: zolpidem 3.5/placebo/zolpidem 1.75
  Interventions:

  • Drug: zolpidem tartrate sublingual tablet 3.5mg
  • Drug: zolpidem tartrate sublingual tablet 1.75mg
  • Drug: Placebo
• Experimental: zolpidem 3.5/zolpidem 1.75/placebo
  Interventions:

  • Drug: zolpidem tartrate sublingual tablet 3.5mg
  • Drug: zolpidem tartrate sublingual tablet 1.75mg
  • Drug: Placebo
• Experimental: zolpidem 1.75/placebo/zolpidem 3.5
  Interventions:

  • Drug: zolpidem tartrate sublingual tablet 3.5mg
  • Drug: zolpidem tartrate sublingual tablet 1.75mg
  • Drug: Placebo
• Experimental: zolpidem 1.75/zolpidem 3.5/placebo
  Interventions:

  • Drug: zolpidem tartrate sublingual tablet 3.5mg
  • Drug: zolpidem tartrate sublingual tablet 1.75mg
  • Drug: Placebo

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