Efficacy and Tolerability of Tasipimidine in Sleepless Patients

Inclusion criteria

• Signed informed consent (IC) for participation in the study.
• Male or female subjects with age between 18 and 65 years.
• Insomnia disorder
• Self-reported history of the following on at least 3 nights per week and for at least 3 months prior to the screening: ≥ 30 minutes to fall asleep, subjective total sleep time ≤ 6 hours.
• Insomnia Severity Index© (ISI©) score ≥ 15 in Part 1 and ≥ 11 in Part 2.
• Usual bedtime between 21:00 and 02:00.
• Regular time in bed between 6 and 9 hours.
• Meeting predefined sleep parameter criteria in sleep recording on the 2 screening nights.
• Highly effective contraception.

Exclusion criteria

• Body mass index below 18.5 or above 40.0 kg/m2.
• Daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
• Shift work within 2 weeks prior to the screening visit, or planned shift work during the study.
• Travel across ≥ 3 time zones within 2 weeks prior to the screening visit, or planned travel across ≥ 3 time zones during the study.
• Use of certain medications affecting central nervous system, e.g. sedatives or stimulans.
• Start of other new chronic medication within 14 days prior screening nights and planned change to an ongoing chronic medication during the study.
• Cognitive behavioural therapy (CBT) is allowed if the CBT started at least 1 month prior to the 1st screening night and the subject agreed to continue the CBT throughout the study.
• Diagnosed sleep-related breathing disorder, including chronic obstructive pulmonary disease and sleep apnoea.
• Acute or unstable psychiatric conditions.
• Alcohol or substance use disorder within 2 years prior to the screening visit or inability to refrain from drinking alcohol for at least 3 consecutive days.
• Significant cardiac disease.
• Significant postural hypotension.
• Heavy tobacco or other nicotine containing product use.
• Caffeine consumption ≥ 600 mg per day or regular caffeine consumption after 4 p.m.
• Heart rate < 50 bpm or > 100 bpm.
• Systolic blood pressure < 100 or > 160 mmHg or diastolic blood pressure < 50 or > 100 mmHg
• Abnormal 12-lead ECG finding.
• Significant abnormal laboratory findings including positive drug screen and presence of alcohol in breath test.
• Pre-planned elective surgery.
• Pregnant or lactating females.
• Blood donation or loss of significant amount of blood prior to the study.
• Participation in a drug study within 60 days prior to the study.
• Restless legs syndrome, circadian rhythm disorder, REM behaviour disorder, or narcolepsy.