Effects of melatonin and zolpidem compared with placebo on sleep disorders in premenopause and menopause women

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014010216035N1

Enrollment

Registered

2014-02-23

Start date

2014-02-20

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Sleep disorder due to premenopause and menopause. Menopausal and female climacteric states

Interventions

Intervention 1: Thirteen participants will be in 2 groups, including two tests and a control groups randomly during in 6 weeks at night, a group treated with melatonin (3 mg) and a group treated with

Treatment - Drugs

Placebo

Thirteen participants will be in 2 groups, including two tests and a control groups randomly during in 6 weeks at night, a group treated with melatonin (3 mg) and a group treated with Zolpidem (10 mg)

Thirteen participants in control group treated with placebo

Eligibility

Sex/Gender

Female

Age

50 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: diagnosis of Pre- menopause and menopause to be confirmed; the absence of chronic medical conditions that can lead to sleep disorders. Exclusion criteria: Failure to diagnosis the menopause and premenopause; use of psychiatric drugs such as anti-psychotics and hypnotics and mood stabilizer drugs; chronic medical conditions leading to sleep disorders (diabetes, cardiovascular diseases, obesity ); autoimmune Diseases; contraindication of taking melatonin (receiving medication of immunosuppressive drugs, sensitivity to melatonin, high blood pressure, liver dysfunction, history of seizures ); sensitivity to Zolpidm; receiving HRT ( hormone replacement therapy ); sleep disorder caused by taking certain psychiatric disorders ( major depression , bipolar, anxiety, dementia); disasters and adverse event

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep Quality. Timepoint: 6 weeks. Method of measurement: Subjective Sleep Quality Questionnaire(PSQI).	—

Secondary

Measure	Time frame
Quality of life. Timepoint: 6 weeks. Method of measurement: SF-36 Quality of Life Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr somayeh shokrgozar

Guilan university of medical sciences

DR.shokrgozar@yahoo.com/Dr_shokrgozar@gums.ac.ir+98 13166

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026