Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria

Male or female subjects 25 to 70 years of age, inclusive
Willing and able to give informed consent for study participation
Each patient must have insomnia disorder based on criteria (ICSD-3 or DSM-5) with predominant complaints of difficulty in initiating or maintaining sleep for at least three months preceding the study visit and having clinically significant distress or impairment in social occupational or other important areas of functioning

Normal vital signs as follows:

Sitting systolic blood pressure (SBP) between 90 and 140 mmHg, inclusive
Sitting diastolic blood pressure (DBP) between 55 and 90 mmHg, inclusive
Pulse rate between 50 and 100 bpm inclusive
Willing to comply with all study requirements and procedures for the duration of the clinical study

Willing to comply with the study restrictions including:

Adherence to concomitant drug washout requirements, as applicable, for the duration of the clinical study
Willing to abstain from alcohol for the duration of the clinical study
Willing to abstain from caffeine 10 hours before each recording
If a smoker, willing to abstain from smoking at night from approximately 10 pm to 8 am for the duration of the clinical study

Female subjects who:

Are postmenopausal, with amenorrhea for at least 1 year before the screening visit,
Are surgically sterile, OR
If of childbearing potential agree to practice effective double barrier methods of contraception, from the time of the signing of informed consent through the last dose of study drug and for 30 days after dosing stops (1 ovulatory cycle), or agree to completely abstain from intercourse
Males with female partners of childbearing potential are also expected to practice effective barrier methods of contraception from the time of signing informed consent through the last dose of study drug and for 30 days after dosing stops.
Self-reported bedtime between 9 pm and midnight on 4-7 nights per week

Based on the PSG recordings during the screening nights (V2; SN1 and SN2), one of the following criteria must be present:

Mean WASO calculated on SN1 and SN2 > 30 min or
Mean LPS: calculated on SN1 and SN2 > 30 min

Exclusion Criteria

Body mass index > 32 calculated from patient's height (m) and weight (kg); weight (kg)/square height (m²)
Presence of a sleep disorder (for sleep apnea syndrome, an apnea-hypopnea index > 15 per hour of sleep on the first screening night will be used as an exclusion criterion; for periodic limb movement disorder, an index of periodic limb movements during sleep associated with an arousal > 10 per hour of sleep on the first screening night will be used as an exclusion criterion)
Patients with a history of epilepsy or seizures (not including benign neonatal and childhood convulsions)
Serious head injury or stroke within the past year
Any evidence of psychiatric disorder (including Beck Depression Inventory [BDI] ≥ 20) and/or history of psychosis excluding insomnia
Evidence of any clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder (including planned medical procedures that may impact sleep), or any condition that may interfere with the absorption, metabolism, distribution, or excretion of the study drug, or may affect patient safety
Clinically significant and abnormal electrocardiogram (ECG; including QTc ≥ 450 ms for males, 460 ms for females) or patients with a history of cardiovascular disease including poorly controlled hypertension, ischaemic heart disease, arrhythmia, or severe heart failure
Positive qualitative urine drug screen (opiates, cocaine, amphetamine, cannabinoids, barbiturates, phencyclidine, benzodiazepines, methadone, propoxyphene), at screening
Use of any substance with psychotropic effects or properties known to affect sleep/wake, including neuroleptics, morphine/opioid derivatives, antihistamines, stimulants antidepressants, clonidine, within one week or five half-lives (whichever is longer) prior to screening
Use of any over-the-counter sleep medications including tryptophan, valerian root (Valeriana officinalis), kava (Piper methysticum Forst), melatonin, St John's Wort (Hypericum perforatum), Alluna (herbal sleep supplement with valerian root), and hemp within 1 week or 5 half-lives (whichever is longer) prior to screening
Consumption of xanthine-containing beverages (i.e., tea, coffee, or cola) of more than 5 cups or glasses per day
Participation in any other trial within 30 days before the screening visit
Night shift workers (during the 12 months prior to the study and during the study)
Individuals who nap 3 or more times per week over the preceding month
Individuals having to travel across more than 3 time zones in the month prior to screening or individuals who plan on travelling outside of their country of residence at any time during the study
Other exclusion criteria based on adverse events (AE) or serious adverse events (SAE) reported in the Investigator Brochure
Women who are pregnant, are planning to become pregnant, or are breastfeeding
Individuals may be excluded from participating in the study based on the investigator's professional judgement