Chamomile for Chronic Primary Insomnia

• Change from baseline of chamomile extract on measures of sleep at day 28. [ Time Frame: baseline and day 28 ] [ Designated as safety issue: Yes ]

  Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days:

  • the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency (SE) (Primary Aim); (ii) total sleep time (TST); (iii) sleep-onset latency (SOL); (iv) and sleep quality (SQ);
  • the change from baseline of global sleep and insomnia symptoms as determined by the (i) Pittsburg Sleep Quality Index (PSQI); and (ii) Insomnia Severity Index (ISI);
  
  

• To determine the change from baseline of chamomile on daytime functioning measures [ Time Frame: baseline and day 28 ] [ Designated as safety issue: No ]

  Change from baseline of chamomile extract, three tablets p.o. twice times daily versus placebo on daytime functioning measures at 28 days:

  • the change from baseline of measures of depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI);
  • the change from baseline of fatigue as determined by the Fatigue Severity Scale of Sleep Disorders (FSS);
  • the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})
  
  
• To evaluate any changes from baseline in the safety and tolerability of Chamomile [ Time Frame: once per week during study and day 28 ] [ Designated as safety issue: Yes ]
  To evaluate any changes from baseline in the safety and tolerability of Chamomile High Grade Extract, three tablets (equivalent to 7.5g of dried herb) p.o. twice times daily versus placebo.
  
  

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.