Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia
Condition: Short-term Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of a combination drug product containing
      diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who
      sometimes have difficulty falling asleep or staying asleep, but who do not have chronic
      insomnia. The study involves 3 one-night stays in a sleep center in New York City.
    

Detailed description: 
      The purpose of this study is to evaluate the effect of a combination drug product containing
      50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam on total sleep time, and to
      determine the contribution of diphenhydramine to the combination, using a 5-hour Phase
      Advance model of sleep challenge. This is a 3-arm cross-over study; each participant will
      receive 3 single-dose treatments on consecutive visits. The 3 arms are: investigational
      combination product, placebo, and a 2-drug comparator containing the zolpidem and lorazepam
      components but not diphenhydramine. Participants will be adults who sometimes have difficulty
      falling asleep or staying asleep, but who are generally healthy and do not have chronic
      insomnia or sleep apnea.

      A total of 39 subjects are being recruited. Subjects who qualify for participation will be
      asked to keep a sleep diary to document their sleep times leading up to and during the study,
      and will be asked to spend 7-8 hours in bed at a regular bedtime during the study. Qualifying
      participants also will not anticipate significant disruptions in their sleep schedules, for
      example by traveling across timezones or changing shifts at work, during the study. The study
      requires 3 one-night stays in a sleep center in New York City, for administration of the
      study treatments and EEG measurements. Qualifying subjects will anticipate being able to
      return to the sleep center, located in Manhattan, for a total of 4 visits, including initial
      screening and 3 treatment times.

      During each sleep center visit, subjects will be given their study treatment and be put to
      bed 5 hours before their usual bedtime, and sleep time will be monitored for 8 hours. Each
      subject will receive all 3 treatments, although the sequence of the 3 treatments will be
      randomized. Both subjects and study personnel monitoring the subjects will be blinded to the
      identity of the treatment administered at each visit.
    

Intervention name(s): SM-1; Comparator; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam; 2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Short-term insomnia; difficulty sleeping; sedative; hypnotic