CTRI/2026/02/102974 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On:
15/04/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A study evaluating the sleep improving effects and safety of Suvorexant in comparison to Lemborexant in participants with Insomnia.
Scientific Title of Study
A Prospective, Multicenter, Randomized, Assessor blind, Parallel-group, Active-Controlled, Phase III Comparative Study to Evaluate the Efficacy and Safety of Suvorexant Tablets in Comparison to Lemborexant Tablets in Patients with Insomnia
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/25/017, Version No. 1.0, 22/AUG/2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President, Head-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House Plot No.201 B/1 Western Express Highway
Goregaon (E)
Mumbai MAHARASHTRA 400063 India
Phone
9819767704
Fax
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Supriya Sonowal
Designation
Senior Manager-Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House Plot No.201 B/1 Western Express Highway
Goregaon (E)
Mumbai MAHARASHTRA 400063 India
Phone
9427003728
Fax
Email
Supriya.Sonowal1@sunpharma.com
Details of Contact Person Public Query
Name
Dr Rajiv Yadav
Designation
Senior Manager-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House Plot No.201 B/1 Western Express Highway
Goregaon (E)
Mumbai MAHARASHTRA 400063 India
Phone
9819435169
Fax
Email
Rajiv.Yadav1@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited (SPIL)
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited (SPIL)
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Ethics Committee, S.M.S. Medical College and Attached Hospitals
Submittted/Under Review
IEC, Institute of Neurosciences
Submittted/Under Review
IEC-Vedant Multispeciality Hospital
Approved
Institutional Ethics Committee, MLN Medical College
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee Gandhi Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee Lakshmi Nursing Home
Submittted/Under Review
Institutional Ethics Committee Mysore Medical College and Associated Hospitals
Approved
Institutional Ethics Committee, Hi-Tech MCH
Submittted/Under Review
Institutional Ethics Committee, Osmania Medical College
Submittted/Under Review
Institutional Ethics Committee, Shree
Approved
IPGMEandR Research Oversight Committee
Submittted/Under Review
KIDS Ethics Committee
Submittted/Under Review
Leelevati Institutional Ethics Committee
Approved
Medilink Ethics Committee
Submittted/Under Review
Sir Ganga Ram Hospital Ethics Committee
Submittted/Under Review
St. Anns Institutional Ethics Committee
Submittted/Under Review
Suraksha Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Lemborexant Tablets 5 mg and 10 mg
Dose: 01 tablet of the prescribed dose should be taken at night immediately before going to bed (with at least 7 hours remaining prior to planned awakening). Patient should not take more than 01 tablet per night. Tablet should not be taken within 01 hour of taking meal
Route, frequency and
method of
administration: Oral
The usual dosage for adults in 5 mg of Dayvigo administered orally once daily immediately before bedtime. The dosage may be adjusted as appropriate
according to the symptom, but should not exceed 10 mg once daily.
Total duration: 17 weeks
Intervention
Suvorexant Tablets 10 mg, 15 mg and 20 mg
Dose: 01 tablet of the prescribed dose should be taken at night within 30 minutes of going to bed (with at least 7 hours remaining prior to planned awakening).
Patient should not take more than 01 tablet per night. Tablet should not be taken within 01 hour of taking meal.
Route, frequency and
method of administration: Oral
The recommended dose for
Suvorexant is 10 mg, taken no more than once per night. If the 10 mg dose is well-tolerated but not effective, the dose can be increased.
The maximum recommended dose
of Suvorexant is 20 mg taken no
more than once per night.
Time to effect may be delayed if taken with or soon after a meal
Total duration: 17 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female, aged 18 to 65 years (both inclusive) at the time of informed consent
2. Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia Disorder
3. Patients should have time to sleep onset greater than or equal to 30 minutes and total sleep time of less than 6.5 hours on at least 4 out of 7 nights in last 4 weeks before screening
4. Insomnia severity index score greater than or equal to 15 at Screening and randomization visit
5. Women of childbearing potential must have a negative urine pregnancy test at screening visit and randomization visit and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined oestrogen and progestogen containing [oral, intravaginal or transdermal] or progesterone only [oral, injectable or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence). [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhoea and be greater than 45 years of age].
6. Male patients must have had a successful vasectomy (confirmed azoospermia) or they and their female partners should be practicing highly effective contraception throughout the study period.
Contraception by female partner is not required if she is not a woman of childbearing potential) [No sperm donation is allowed during the study period]
ExclusionCriteria
Details
Patient will be excluded if any of the exclusion criteria listed below is met:
1. Patients with Body Mass Index (BMI) greater than 40 kg/m2
2. Patients with history of sleep related breathing disorders such as obstructive sleep apnea, central sleep apnea periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorder, narcolepsy, cataplexy, parasomnia including nightmare disorder, sleep terror disorder, sleep walking disorder, sleep driving disorder, primary hypersomnia, excessive daytime sleepiness disorder not attributable to primary insomina, periodic limb movement disorder
3. Patient who have difficulty sleeping due to underlying medical condition such as but not limited to cardiac disease, nocturia (greater than 3 times/night), asthma, gastroesophageal reflux disease (GERD), hot flashes, pain due to chronic conditions, migraine etc
4. Patients with major travel (across time zones) in 2 weeks prior to screening or expected to travel during the study
5. Patients with history of working in shifts and/or working in night shifts in 2 weeks prior to screening or will be required to work in a shift and/or night shift during the study.
6. Patients with neurological disorder, such as but not limited to seizures, stroke, transient ischemic attack, multiple sclerosis, cognitive impairment, or clinically significant head trauma
7. Patient who has history of any psychiatric condition such as bipolar disorder, major depression, posttraumatic stress disorder etc.
8. A lifetime history of a suicidal attempt or history of Suicidal behaviour or suicidal ideation within 4 weeks before screening
9. Patients with History of alcohol or substance dependency or abuse in last 2 years
10. Patients with positive result of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening visit
11. Patients with any significant cardiovascular abnormality including acute coronary syndrome, unstable angina, congestive heart failure (NYHA III or IV), cardiogenic syncope, cardiomyopathy, Any symptomatic arrythmia, AV conduction diseases (second- or third-degree AV block), sick sinus syndrome, bradycardia (heart rate at resting less than 45 at screening), or accessory bypass tract (for example, Wolff- Parkinson-White), QTcF greater than 450 ms) at screening.
12. Patients with history of any liver disorder of gastrointestinal disorder or gastrointestinal surgery including gastric bypass or gastric banding surgery.
13. Subject had a history of malignancy 5 years or more prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
14. Patients who are not willing to avoid alcohol during the study
15. Prior use of orexin receptor antagonist and no adequate response to therapy
16. Hypersensitivity to the study drug or any of the excipients.
17. Patients with history of any clinically significant medical and/or psychological condition or laboratory abnormalities that, in the opinion of the Investigator or Sponsor’s Medical Monitor would jeopardize the safety of the patient or affect the validity of the study results
18. Patient with history of participation in another clinical trial in the past 3 months of Screening
19. Employee of the Sponsor or Investigator or study centre with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members of the employees of Sponsor or the Investigator
Method of Generating Random Sequence
Stratified randomization
Method of Concealment
On-site computer system
Blinding/Masking
Investigator Blinded
Primary Outcome
Outcome
TimePoints
Change from baseline in latency to sleep onset at week 12
Week 12
Secondary Outcome
Outcome
TimePoints
Change from baseline in latency to sleep onset till week 8
Week 8
Change from baseline in total sleep time till week 12
Week 12
Change from baseline in wakefulness after persistent sleep till week 12
Week 12
Change from baseline in number of awakenings at till week 12
Week 12
Change from baseline Insomnia Severity Index (ISI) till week 12
Week 12
Target Sample Size
Total Sample Size="410" Sample Size from India="410" 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
Phase 3
Date of First Enrollment (India)
16/02/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="29"
Recruitment Status of Trial (Global)
Not Applicable
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 Phase III, randomized, assessor-blind,
multi-center study aims to compare the safety and efficacy of Suvorexant
Tablets to Lemborexant Tablets in patients diagnosed with Insomnia. The trial
will be conducted across 20 to 30 qualified centres in India and will begin
only after receiving regulatory and ethics committee approvals.
A total of 410 patients will approximately be enrolled in the trial.
After confirming eligibility, patients will be randomized in 1:1 ratio to
either Test arm or Comparator arm (205 patients in Test arm and 205 patients in
Comparator arm). Patients will receive the study drugs till week 12.
Patients will be provided a sleep diary wherein
patients will record sleep related information (latency to sleep, total sleep
time, wakefulness after sleep, number of awakening during the night) along with
adverse events and concomitant medications if any. The primary end point of the
study is to assess change from baseline in latency to sleep onset at Week 12. Safety
assessments will include recording of AEs, TEAEs, serious adverse events
(SAEs), vital signs [pulse rate, systolic and diastolic blood pressure
(seated), body temperature and respiratory rate], ECG, physical examination,
clinical laboratory investigations (hematology, biochemistry and urinalysis).