Pilot study of the efficacy and safety of lettuce seed oil in patients with sleep disorders

BACKGROUND Lactuca sativa (garden lettuce) is a popular salad herb. It has been in use in folk medicine since ancient times as both an appetite stimulant and as an aid to sleep. L. sativa seed oil (Sedan(®)) has demonstrated a pronounced sedative effect and potentiated the hypnotic effect of barbiturates in animal models. It also exhibited significant analgesic and anti-inflammatory activities. In this study, we evaluated the sedative and hypnotic effects of L. sativa in patients suffering from insomnia. METHODS Sixty patients suffering from insomnia with or without anxiety were randomized to receive capsules containing L. sativa seed oil 1000 mg (n = 30) or placebo (n = 30). All patients were asked to complete a verbal questionnaire before the start of the trial and 1 week after starting treatment. RESULTS Improvements in the modified State-Trait Anxiety Inventory and the Sleep rating scale scores were significantly greater in patients receiving L. sativa seed oil compared with those on placebo (P < 0.05). No side effects were found to be attributable to L. sativa seed oil at the given dosage. CONCLUSION L. sativa seed oil was found to be a useful sleeping aid and may be a hazard-free line of treatment, especially in geriatric patients suffering from mild-to-moderate forms of anxiety and sleeping difficulties.