The DTB has reviewed the place in therapy of melatonin as a treatment for primary insomnia, following the recent licensing of prolonged-release melatonin (Circadin™) for the short term treatment of primary insomnia in patients aged 55 years and over.

The review concludes that compared to other hypnotic drugs, there appears to be no evidence of dependence, withdrawal effects or rebound insomnia associated with melatonin. However, while published trials suggest some benefit of melatonin compared with placebo, there are no head-to head studies with other non-drug or drug treatments and the limited evidence on efficacy does not provide a convincing basis for recommending its use.