Zolpidem Pharmacokinetics in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Overseen By William D Figg, Pharm.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Sedative hypnotics, CYP3A4 drugs

Disqualifiers: Cardiac disease, Hepatitis, Psychiatric issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests how a sleep medication called zolpidem works in men with prostate cancer and healthy women. It aims to see if hormone levels affect how the drug is processed in the body. Participants will take the medication and have their blood tested to measure drug levels. Zolpidem is a widely prescribed medication used for treating sleep disorders.

Will I have to stop taking my current medications?

The trial requires that participants stop taking certain medications. Male participants cannot take medications that affect zolpidem metabolism, like strong CYP3A4 inhibitors or inducers. Female participants must not be on regular medications, except contraceptives, within two weeks before the study.

What data supports the effectiveness of the drug Zolpidem in prostate cancer patients undergoing androgen deprivation therapy?

Zolpidem is effective in helping adults fall and stay asleep, as shown in studies where it improved sleep in solid tumor patients. It is a strong sedative that works by binding to specific receptors in the brain, and it has been shown to maintain good daytime alertness without causing withdrawal effects. ^{1 2 3 4 5}

Is zolpidem generally safe for humans?

Zolpidem, also known as Ambien, has been studied in various populations and is generally considered safe for humans. Studies show no serious adverse events, and it does not produce rebound or withdrawal effects. However, women may experience higher exposure and delayed recovery from its effects compared to men. ^{1 3 5 6 7}

How does the drug Zolpidem differ from other treatments for prostate cancer patients undergoing androgen deprivation therapy?

Zolpidem is primarily a sedative used to help with sleep, and its use in prostate cancer patients undergoing androgen deprivation therapy is unique because it is not a standard treatment for cancer but may help manage sleep disturbances in these patients. ^{3 5 6 7 8}

Research Team

William D Figg, Pharm.D.

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Men over 18 with prostate cancer planning to undergo androgen deprivation therapy, and healthy women over 18 can join. Participants must have normal organ function, not be on certain medications or have other cancers, serious illnesses, or psychiatric conditions that could affect the study.

Inclusion Criteria

Willingness to travel to NIH for follow-up visits.

I haven't had any other cancers except for non-dangerous skin cancer or very early stage leukemia in the last 2 years.

Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

I do not have any serious illnesses that would stop me from following the study's requirements.

I do not have severe heart problems or recent heart attacks.

I have no liver, stomach, or other conditions affecting medication processing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment - Pre-ADT

Participants receive a single 5 mg dose of zolpidem followed by an 8-hour pharmacokinetic evaluation

1 day

Overnight stay

Treatment - Post-ADT

After undergoing androgen deprivation therapy and reaching castrate testosterone levels, participants receive another 5 mg dose of zolpidem followed by an 8-hour pharmacokinetic evaluation

1 day

Overnight stay

Follow-up

Participants receive a follow-up phone call after each overnight stay to monitor for any adverse events

3 days

Treatment Details

Interventions

• Zolpidem

Trial Overview The trial is testing how castration affects the levels of Zolpidem in men with prostate cancer compared to its levels in healthy women. Men will take Zolpidem before and after their testosterone-lowering treatment; both groups will stay overnight for monitoring.

Participant Groups

Group I: Zolpidem pre and post castration Experimental Treatment 2 Interventions

5 mg oral dose of zolpidem prior to undergoing androgen deprivation therapy (ADT) followed by 5 mg oral dose of zolpidem after ADT and testosterone reaches castrate levels

Group II: Female Active Control 2 Interventions

Single 5 mg oral dose of zolpidem

Zolpidem is already approved in United States, European Union for the following indications:

Approved in United States as Ambien for:

• Insomnia
• Limited use in central sleep apnea syndromes under strict conditions

Approved in European Union as Zolpidem for:

• Insomnia
• Not specifically approved for central sleep apnea but may be considered off-label

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of zolpidem and sleep hygiene counseling in the treatment of insomnia in solid tumor patients. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Use of tranquilizers and sleeping pills among cancer patients is associated with a poorer quality of life. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical pharmacokinetics and pharmacodynamics of zolpidem. Therapeutic implications. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetic profile of a new modified release formulation of zolpidem designed to improve sleep maintenance. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Effect of CYP3A4 metabolism on sex differences in the pharmacokinetics and pharmacodynamics of zolpidem. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and brain distribution of zolpidem in the rat after acute and chronic administration. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Gender differences in pharmacokinetics and pharmacodynamics of zolpidem following sublingual administration. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Zolpidem pharmacokinetic properties in young females: influence of smoking and oral contraceptive use. [2019]