Chamomile for Chronic Primary Insomnia

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if an herb called chamomile can help to treat insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of time that you sleep and/or improving the quality of your sleep. The study will also be looking at the effect of chamomile on day time fatigue and functioning.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan

Criteria

Inclusion Criteria:

• Men and women aged 18 to 64 years;

• Must be able to give written informed consent;

• Have a diagnosis of primary insomnia per DSM-IV criteria, reporting < 6.5 hours sleep and/or >30 minutes to fall asleep (SOL) and/or wake after sleep onset (WASO) > 30 minutes, three or more nights per week;

• Present sleep complaint for at least 6 months;

Exclusion Criteria:

• Women who are pregnant, lactating or less than six months post-partum. Due to the fact that an assessment of reproductive performance and teratology tests have not been conducted we are excluding pregnant and lactating women;

• Patients with unstable medical conditions;

• DSM-IV Axis I or personality disorder diagnosis with the exception of patients with treated and stable unipolar depression or generalized anxiety disorder (such that the PRIME-MD scores are within normal range for these disorders);

• Difficulty in sleep initiation or maintenance associated with known medical diagnosis or conditions that may affect sleep, e.g., sleep apnea, restless leg syndrome, chronic pain;

• Evidence of lack of reliability or noncompliance as defined by missing a pretreatment appointment more than twice;

• Current diagnosis of substance abuse or dependence;

• Known allergy to chamomile or members of the ragweed family;

• Currently taking cyclosporine, warfarin or chronic sedative and anxiolytic medications;

• Prior use of insomnia medications is not exclusionary, but patients must be off of these medications at the screening visit and through out the study.