Efficacy and Safety of Melatonin vs Zolpidem oral Spray in Insomnial Disorder Investigator initiated clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study proposes a randomized , open label, investigator initiated and outcome assessor blinded trial to compare the efficacy and safety of melatonin oral spray (approved to use in india by fssai as health supplements /nutraceuticals from 2-10mg) versus zolpidem oral spray in adults 18 to 65 years with DSM 5 defined insomnia disorder. Insomnia is highly prevalent in India and is associated with significant morbidity and reduced quality of life. While zolpidem is effective, it carries risks of dependence and adverse effects, whereas melatonin is safer but limited by variable oral absorption. Oral spray formulations may offer faster absorption and improved adherence, yet comparative evidence is lacking.
A total of 40 participants (20 in each group) (for piloting basis which will be helpful for taking go no go decision to recruit final sample of 80 in each group) will be randomized 1 is to 1 to receive either melatonin spray 3 mg or zolpidem spray 5 mg sublingually once nightly for 14 days. Primary outcomes include changes in Insomnia Severity Index and Sleep Quality Scale scores at baseline, day 7, and day 14. (As a rescue option, melatonin oral spray dose may be increased upto maximum 6mg as well as those in zolpidem group, will be switched to 10 mg zolpidem tablets, will be out of study).
Findings are expected to provide robust Indian data on oral spray formulations for insomnia and may support melatonin as a safer, effective alternative to zolpidem in short term insomnia management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
Prof Dr Ajay Mishra
SCB medical college and hospital