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Comparing Two Sleep Medicines Lemborexant and Zolpidem for Treating Long Term Insomnia in Adults

Efficacy and Safety of Lemborexant versus Zolpidem in Primary Chronic Insomnia A Double blind Double Dummy Randomized Controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112618
Enrollment
80
Registered
2026-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition

Interventions

Intervention1: Lemborexant: Oral Tablet 5mg administered once nightly before bedtime for 4week Patient will also receive a Matching Zolpidem Placebo Tablet to Maintain the Double Dummy Design Control

Sponsors

Roshankumar Ganpatbhai Patel
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age 18 to 65 years either sex 2 Confirmed diagnosis of Primary Chronic Insomnia Disorder as per Diagnostic Statistical Manual 5th edition criteria 3 Aathans Insomnia Scale total score 6 or more than 6 at screening 4 Patients with insomnia for at least 4 weeks prior to enrolment 5 Willing and able to provide written informed consent 6 Able to understand and comply with study procedures and follow up visits

Exclusion criteria

Exclusion criteria: 1 Confirmed obstructive sleep apnoea narcolepsy restless legs syndrome or REM sleep behaviour disorder 2 Active suicidal ideation or significant suicide risk as per clinical judgment 3 Known hypersensitivity or contraindication to lemborexant zolpidem or any excipients 4 Severe hepatic impairment or severe renal impairment 5 Shift workers with documented circadian rhythm disorder 6 Current use of potent CYP3A4 inhibitors or inducers 7 History of substance abuse or alcohol dependence within the past 6 months 8 Any acute medical or psychiatric emergency requiring immediate intervention 9 Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
to compare Sleep Onset Latency minutesTimepoint: 0day 7day 14day 28day—

Secondary

MeasureTime frame
1 To compare the total sleep duration 2 To compare the overall quality of sleep 3 To compare the Wake After Sleep Onset 4 To assess and compare medication adherence 5 To evaluate and compare the incidence nature and severity of adverse drug reactionsTimepoint: 0day 7day 14day 28day—

Countries

India

Contacts

Public ContactRoshankumar Ganpatbhai Patel

Zydus Medical College and Hospital

drprashant.parmar1490@gmail.com8866273360

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026