Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
Intervention1: Melatonin oral spray: Melatonin spray 3 mg per spray once sublingually 1 hour before bedtime
for 14 days
Control Intervention1: Zolpidem oral spray: Zolpidem spray 5 mg per spray once s
Sponsors
Prof Dr Ajaya Mishra
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 65 years, male or female. Diagnosis of insomnia disorder DSM 5 with symptoms of sleep difficulty present for at least 3 months and least 3 days per week despite adequate opportunity for sleep Predominant complaint of dissatisfaction with sleep quantity or quality, associated with one or more of Difficulty initiating sleep taking more than or equal to 30 minutes to fall asleep Difficulty maintaining sleep frequent awakenings or difficulty returning to sleep Early morning awakening with inability to return to sleep. Able and willing to provide written informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: Insomnia symptoms lasting less than 3 months and or or less than or equal to 2 nights per week. Presence of another primary sleep wake disorder e.g., sleep apnea, restless legs syndrome, narcolepsy, circadian rhythm disorder, parasomnia. Untreated or unstable psychiatric conditions e.g., major depression, anxiety disorders, psychosis Use of medications or substances known to affect sleep e.g., benzodiazepines, hypnotics, antidepressants, stimulants within 2 weeks prior to screening. Substance abuse or dependence within the past 6 months. Significant medical conditions affecting sleep e.g., uncontrolled thyroid disease, chronic pain, severe cardiovascular or respiratory disease. Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception. Shift workers or individuals with irregular sleep schedules.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change (improvement or no improvement) in Sleep Quality Scale (28 SCALE) from day one to da7 and day 14 and Insomnia Severity Index (ISI) 7 item scale scores from day 1 to day 7 to day 14Timepoint: change in scores of standadized scales from day 1 to day 7 and day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL;Assess changes in polysomnography-derived metrics: sleep latency, sleep efficiency, total sleep time, and wake after sleep onset (WASO) at 14 day. -Evaluate the safety and tolerability of the oral spray formulations as assessed at day 7 and day 14.Timepoint: Day 7 and day 14 | — |
Countries
India
Contacts
Public ContactProf Dr Ajay Mishra
SCB medical college and hospital
Outcome results
None listed