Evaluation in patients affected by middle of the night (MONT) awakenings using different dosages of triazolam

INTERVENTION: Trade Name: Songar 0,375 mg/ml gocce orali, soluzione Pharmaceutical Form: Oral drops, solution CONDITION: Insomnia characterized by difficulty returning to sleep following a nocturnal awakening, otherwise called middle‐of‐the‐night (MONT) insomnia ; MedDRA version: 14.1 Level: LLT Classification code 10029448 Term: Nocturnal awakening System Organ Class: 100000004873 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of different triazolam dosage in patients affected by difficulty returning to sleep following a nocturnal awakening Primary end point(s): To evaluate the efficacy of different triazolam dosage Secondary Objective: To evaluate the next morning residual effects of triazolam Timepoint(s) of evaluation of this end point: Each morning. SECONDARY OUTCOME: Secondary end point(s): To evaluate the next morning residual effects of triazolam Timepoint(s) of evaluation of this end point: each morning and every week with the vigilance tests INCLUSION CRITERIA: ‐ Night‐time awakening (>= 5 nights/week) followed by a difficult to fall asleep in men or female aged over 18 years. ‐ Latency to sleep after the night‐time awakening: > 45 minutes ‐ No difficult to fall asleep at the evening (Sleep Latency < 30 minutes) ‐ Moderate use of alcool (max 2 glasses of wine/day), caffeine (not after 5 pm and max 2 cups/day) e nicotine (max 10 cigarettes/day) ‐ No pregnancy, if woman Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4