Neurexan - a Clinical Trial in Short-Term Insomnia Patients

Inclusion Criteria:

1. Insomnia definition according to Diagnostic and Statistical Manual of MentalDisorders, 5th edition (DSM-5) criteria; episode duration less than 3 months.
2. Short-term insomnia with moderate symptoms according to Insomnia Severity Index (ISI)of at least 8 and below 22 being present for at least one week, but no longer than 3months prior to Screening Visit.
3. Reports habitual bedtime, defined as the time the participant attempts to sleep,between 21:00 and 01:00.
4. Reports regular time spent in bed, either sleeping or trying to sleep, between 6 and 9hours.
5. ≥18 years of age, not older than 65 years.
6. Legally competent male or female patient.
7. Signed Informed Consent.
8. Females of childbearing potential must agree to maintain highly effective oracceptable birth control throughout the trial (CTFG 2020).
9. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 at Screening Visit.
10. Use of digital device e.g., smartphone, tablet or laptop.
11. German speaking and reading.

Exclusion Criteria:

1. Patients with insomnia symptoms present longer than 90 days prior to Screening Visit.
2. Based on the diagnostic interview, reported history (within 2 years) of other sleepdisorders (e.g., chronic insomnia, circadian rhythm sleep disorders, restless legssyndrome (RLS), obstructive sleep apnea (OSA)), i.e., STOPBang (SBQ) questionnairescore ≥5, International Restless Legs Scale score ≥16).
3. Based on the first polysomnographic screening night at Baseline 1, insomnia due tosleep apnea or periodic limb movement disorder (PLMD): OSA (Apnea Hypopnea Index of >5events/ hour), PLMD (Periodic Limb Movement Index (PLMI) >15 events/ hour).
4. Rotating shift work with overnight shifts.
5. History of psychiatric disorders within the last 6 months prior to Screening Visitaccording to the Structured Clinical Interview for DSM-5® Disorders - ClinicianVersion (SCID-5-CV).
6. History of sensitivity to any component of Neurexan®.
7. Unwilling or unable to comply with all the requirements of the clinical trialprotocol.
8. Cognitive impairment (cut-off of 24 points in the Montreal Cognitive Assessment [MoCA]; at Screening Visit.
9. Any history of or current abuse of alcohol and/or amphetamines, benzodiazepines,cocaine, marijuana, methaqualone, methadone, opioids, propoxyphene, barbiturates,phencyclidine; or expected to take during trial participation (urine drug screening atScreening Visit and adaptation nights).
10. Current use of medication affecting sleep, i.e., antidepressants, antipsychotics,diuretics, blood pressure drugs, anti-dementia drugs (e.g., piracetam), herbal andhomeopathic medicine, hormone preparations (e.g., thyroxine) with the exception ofhormonal contraceptives.
11. Use of Neurexan® within the last two weeks from Screening Visit.
12. Non-pharmacological insomnia therapies (e.g., cognitive behavioral therapy within thelast 6 months of Screening Visit, sleep restriction therapy, complementary andalternative therapies as meditation, Traditional Chinese Medicine, aromatherapy).
13. Excessive consumption of xanthine-containing beverages (more than 7 cups daily ofcoffee or tea or other beverages containing xanthines).
14. Use of nicotine during the last 6 months prior to Screening Visit.
15. Participation in any interventional clinical study within the past 30 days prior toScreening Visit.
16. Any relationship of dependence with the Sponsor or with the Investigator.
17. Active infection/ disease (C-Reactive Protein [CRP] >5 mg/l).
18. Hypertension defined as systolic blood pressure ≥140 mmHg.
19. History of neurological, rheumatic, chronic pain, immune, cardiovascular, pulmonary,liver/ kidney, or metabolic disorder within the last 6 months prior to ScreeningVisit.
20. Nocturia.
21. Pregnancy (as proven by positive urine pregnancy test at Screening Visit) orbreastfeeding.
22. Patients with moderate to severe skin allergies and/or eczema.
23. Raynaud's disease.
24. Donation of blood or platelets 3 months prior to or in-between in-hospital visits.