| CTRI Number |
CTRI/2026/01/102019 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy and Safety of Melatonin vs Zolpidem oral Spray in Patients with Insomnia Disorder |
|
Scientific Title of Study
|
Efficacy and Safety of Melatonin vs Zolpidem oral Spray in Insomnial Disorder Investigator initiated clinical trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Ajay Mishra |
| Designation |
HOD of department of Psychiatry |
| Affiliation |
SCB medical college and hospital |
| Address |
Department of Psychiatry
SCB medical college and hospital
Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9437277703 |
| Fax |
|
| Email |
dr.ajayamishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ajaya Mishra |
| Designation |
Professor & HOD of department of Psychiatry |
| Affiliation |
SCB medical college and hospital |
| Address |
Department of Psychiatry , Mental Health Institute,
SCB medical college and hospital
Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9437277703 |
| Fax |
|
| Email |
dr.ajayamishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ajay Mishra |
| Designation |
HOD of department of Psychiatry |
| Affiliation |
SCB medical college and hospital |
| Address |
Department of Psychiatry
SCB medical college and hospital
Cuttack
Cuttack
ORISSA
753007
India |
| Phone |
9437277703 |
| Fax |
|
| Email |
dr.ajayamishra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prof Dr Ajaya Mishra |
| Address |
Professor and HOD, Director, Mental Health institute, SCB medical college and hospital, Cuttack
Cuttack |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajaya Mishra |
SCB Medical College and Hospital, Cuttack, Odisha |
Room no 9, Department of Psychiatry Mental Health Institute, SCB medical college and hospital,
Cuttack
Cuttack
ORISSA |
9437277703
dr.ajayamishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, SCB Medical College and Hospital, Cuttack |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin oral spray |
Melatonin spray 3 mg per spray once sublingually 1 hour before bedtime
for 14 days |
| Comparator Agent |
Zolpidem oral spray |
Zolpidem spray 5 mg per spray once sublingually 1 hour before bedtime
for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 14 |
change in scores of standadized scales from day 1 to day 7 and day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
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. |
Day 7 and day 14 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |