Do you have trouble going to sleep at night? Do you have trouble staying asleep? If so, you may have Insomnia. At Albuquerque Neuroscience Inc., they are studying a new drug being tested for the treatment of insomnia.
Lemborexant is an investigational study drug being tested for the treatment of insomnia. They are studying two oral doses, 5 and 10 mg, to be taken a few minutes before bedtime.
The purpose of this study is to assess the transition from Zolpidem or Ambient to Lemborexant.
They are looking for individuals, male or female, 18 years or older, who have been diagnosed with Insomnia and are currently taking Zolpidem.
The study will consist of 3 phases:
- A Pretreatment Phase (consisting of up to a 3-week Screening Period and a 1-day Baseline Period)
- A Treatment Phase (consisting of a 2-week Titration Period)
- An Extension Phase consisting of the Maintenance Period up to 12 weeks and the Follow-up Period 4 weeks in duration immediately following the end of the Treatment Phase.
The Pre-treatment and Treatment Phases will comprise the Core Study. A Follow-up Period visit occurring 4 weeks after the end of the Extension Phase (or Treatment Phase, for subjects not entering the Extension Phase) will be conducted.
To take part in the program, participants must have a diagnosis of Insomnia and must be currently taking Zolpidem at least 3 but fewer than 5 nights per week, for at least the last 2 weeks of the 3-week Screening Period. Eligible participants may then be invited to join the treatment phase, where they will receive the investigational treatment.