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Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia

E

EMS

Status and phase

Not yet enrolling
Phase 3

Conditions

Chronic Insomnia

Treatments

Drug: Sublingual Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT05456152
EMS0222- SERENA

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.

Enrollment

358 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
  • Age between 18 to 64 years;
  • Participants diagnosed with chronic insomnia defined by difficulty in initiating or maintaining sleep in the last 3 months for at least 3 nights a week according to DSM-V criteria and confirmed by polysomnography;
  • Participants with difficulty in initiating or maintaining sleep parameters.

Exclusion criteria

  • Participants with clinical or laboratory diagnose of non-treated hypothyroidism or hyperthyroidism, kidney or liver failure;
  • Known hypersensitivity to any of the formula compounds;
  • Participants with other sleep disorders according to the International Classification Sleep Disorders (3rd edition), example: sleep-relate breathing disorders, circadian rhythm sleep-wake disorders, parasomnias (including history of sleep-walking after hypnotic use) and sleep related movement disorders;
  • Participants using sedatives or hypnotic medications;
  • Participants with current diagnosis of depression or anxiety according to the Diagnostic and Statistical Manual of Mental Disorders;
  • Participants with history of drug and alcohol abuse in the past 2 years;
  • Participants with current smoking habits during the night period;
  • Participants who treated insomnia in the last 3 months;
  • Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
  • Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
  • Participants with current or medical history of cancer in the last 5 years;
  • Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

358 participants in 1 patient group

Sublingual zolpidem
Experimental group
Description:
1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.
Treatment:
Drug: Sublingual Tablet

Trial contacts and locations

1

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Central trial contact

Alexandra F.D. Alves, MSc

Data sourced from clinicaltrials.gov

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