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.