Conditions: Insomnia
Keywords: Insomnia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 295
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: zolpidem tartrate sublingual tablet intervention 2: Placebo
Intervention descriptions: intervention 1: 3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 2: Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Protocol document: