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 atleast 3 months prior to the screening: ≥ 30 minutes to fall asleep, subjective totalsleep 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 screeningnights.

• 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 duringthe study.

• Travel across ≥ 3 time zones within 2 weeks prior to the screening visit, or plannedtravel across ≥ 3 time zones during the study.

• Use of certain medications affecting central nervous system, e.g. sedatives orstimulans.

• Start of other new chronic medication within 14 days prior screening nights andplanned change to an ongoing chronic medication during the study.

• Cognitive behavioural therapy (CBT) is allowed if the CBT started at least 1 monthprior to the 1st screening night and the subject agreed to continue the CBTthroughout the study.

• Diagnosed sleep-related breathing disorder, including chronic obstructive pulmonarydisease and sleep apnoea.

• Acute or unstable psychiatric conditions.

• Alcohol or substance use disorder within 2 years prior to the screening visit orinability 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 presenceof 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, ornarcolepsy.