Prolonged-release melatonin versus temazepam and zolpidem during sleep

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled four-way cross-over trial to study the effects of prolonged-release melatonin, temazepam and zolpidem on the spectral composition of the EEG during nocturnal sleep in healthy middle-aged men and women.

• IRAS ID

  9161

• Sponsor organisation

  University of Surrey

• Eudract number

  2008-006222-34

• ISRCTN Number

  N/A

• Research summary

  This study has been designed to compare the effects of melatonin with those of drugs (temazepam and zolpidem) regularly prescribed for the treatment of insomnia, in healthy, middle-aged volunteers. The study will take place at one centre. Volunteers consenting to participate in the study will have their eligibility confirmed by screening panel, including spending one night in the sleep clinic to acclimatize to the study procedures. Blood and urine samples will be collected during this overnight visit. Volunteers continuing to remain eligible will receive, in turn, melatonin, temazepam, zolpidem and placebo as a single dose during 4 treatment phases lasting one night and separated by at least five days. Neither the volunteer nor the study staff will be aware of which drug each volunteer is receiving at each treatment phase. The volunteer's electrical brain activity will be measured whilst sleeping. Other aspects of sleep, including measures of sleep quality, will also be measured. Urine samples will be collected during each treatment phase. Volunteers will undergo an assessment of health prior to departure from the clinic at their last treatment phase, and study staff will telephone 2 weeks later to obtain further information on their health status.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  09/H0717/6

• Date of REC Opinion

  20 Mar 2009

• REC opinion

  Further Information Favourable Opinion