Insomnia

Insomnia

This study is currently active

Purpose of Study:  The purpose of this study is to assess if you can successfully transition from zolpidem to XXX. Also to determine the effectiveness and safety of next-dose transition from zolpidem to XXX.

Study Length: 5 months

# of Visits and length/Compensation:  5 Visits

First visit 1 ½ hours, all other visits 45 minutes

Study procedures: URINE DRUG SCREEN, Physical, EKG, Lab Work and Questionnaires

Compensation for participation: up to $300

Inclusion Criteria:

  • Male or female 18 or over
  • Complains of dissatisfaction with nighttime sleep, in the form of difficulty staying asleep and/or awakening earlier in the morning than desired despite adequate opportunity for sleep
  • Frequency of complaint >3 times per week
  • Duration of complaint >3 months
  • Association with a complaint of daytime impairment
  • Reports spending at least 7 hours in bed per night
  • History of intermittent (taking zolpidem at least 3 but fewer than 5 nights per week), or frequent use (at least 5 nights per week) of Zolpidem IR or ER for at least 1 month
  • Females must be using a highly effective form of contraception:
    • Total abstinence
    • IUD
    • Implant
    • Pill
    • Vasectomized partner with confirmed azoospermia
    • Postmenopausal ( 12 months since last period)
    • Hysterectomy
    • Oophorectomy

Exclusion Criteria:

  • Females Breastfeeding or pregnant
  • Any history of moderate to severe sleep apnea
  • Bronchiectasis,  emphysema, asthma, COPD or other pulmonary disorder that could compromise the subject
  • A current diagnosis of periodic limb movement disorder, restless leg syndrome, circadian rhythm sleep disorder
  • Habitually naps during the day more than 3 times per week
  • Reports symptoms potentially related to narcolepsy
  • Takes a dose of zolpidem  IR >10mg per night or zolpidem ER >12.5mg per night
  • Reports having altered zolpidem tablets
  • Unwilling to forgo alcohol consumption within 3 hours of bedtime for the duration of participation in the study
  • Any other medications or marijuana to treat insomnia other than zolpidem
  • Any lifetime suicidal behavior
  • Planned surgeries that require general, spinal or epidural anesthesia
  • Psychotic disorder or unstable recurrent affective disorder evident by the use of antipsychotics or prior suicide attempt within the last 2 years
  • History of drug or alcohol dependency or abuse within approximately the last 2 years

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