Is melatonin helpful in stopping the long-term use of hypnotics? A discontinuation trial

Pharm World Sci. 2007 Dec;29(6):641-6. doi: 10.1007/s11096-007-9118-y. Epub 2007 Jul 3.


Objective: To find out if administration of melatonin facilitates discontinuation of benzodiazepine (BD) therapy in patients with insomnia.

Method: A placebo controlled trial in nine general practices in the Netherlands. Long-term users of benzodiazepines were asked by their GP to participate in a discontinuation program in combination with melatonin or placebo. The intervention and follow-up period lasted one year. During this period participants received four questionnaires about their use of sleeping medication and several health instruments. The urine of all participants was tested for the presence of benzodiazepines, as proof of the discontinuation.

Main outcome measure: The discontinuation of benzodiazepine use measured by questionnaires and urine samples at three assessment points.

Results: A total of 503 long-term users were selected by the GPs, of whom 38 patients (16M/22F) participated. After one year 40% had stopped their benzodiazepine use, both in the intervention group on melatonin and in the placebo control group. Comparing stoppers and non-stoppers did not reveal significant differences in benzodiazepine use, or awareness of problematic use.

Conclusion: Our findings do not conclusively indicate that melatonin is helpful for the discontinuation of the use of benzodiazepines, but the average dose of benzodiazepines in the group was low. Further investigation is necessary, with special attention to the possible influence of the daily dose on the facilitation effect of melatonin.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Benzodiazepines / therapeutic use*
  • Female
  • Humans
  • Hypnotics and Sedatives / therapeutic use*
  • Male
  • Melatonin / therapeutic use*
  • Middle Aged
  • Sex Characteristics
  • Sleep Initiation and Maintenance Disorders / drug therapy*


  • Hypnotics and Sedatives
  • Benzodiazepines
  • Melatonin