Chamomile for Chronic Primary Insomnia

Insomnia, defined as the inability to initiate or maintain sleep or lack of restorative
sleep, is the most prevalent sleep complaint in primary care. Insomnia is associated with
decreased quality of life, work limitations and increased healthcare utilization. Currently
there is no treatment for chronic insomnia that is readily available, affordable, without
significant side-effects and demonstrated to be safe for long term use. Consequently,
treatments that would fill this gap are needed.

Chamomile (Matricaria recutita) has been used as a gentle sleep agent by herbalists for
several hundred years. It has been studied in animals for its sedative potential and shows
promise for treating insomnia. Currently, chamomile's sedative mechanisms of action are
unknown, but are thought to be through the major inhibitory neurotransmitter in the central
nervous system, γ - aminobutyric acid (GABA). However, no study has examined chamomile's
efficacy and safety for treating insomnia.

The investigators propose a double-blind, placebo-controlled, randomized trial of chamomile
in primary care patients with chronic insomnia. Thirty-four patients will be randomized to
either Chamomile High Grade Extract, three 5 mg tablets standardized to 0.4% (-)-α-bisabolol
twice daily or placebo and will be followed for 28 days for changes in a sleep diary (sleep
efficiency, total sleep time, sleep-onset latency and sleep quality), insomnia severity and
sleep disturbances. Secondary endpoints include assessing changes in day time functioning
(measures of global quality of life, depression and anxiety) and monitoring for any signs of
toxicity. The investigators will also determine the feasibility of conducting a larger trial
with this agent.

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.