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Treatment of primary insomnia with melatonin: a double-blind, placebo-controlled, crossover study
Luis G Almeida Montes1, Marta P Ontiveros Uribe, José Cortés Sotres
1Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz, Calzada México Xochimilco No. 101, San Lorenzo Huipulco, Tlalpan México DF, Mexico. almeidal@prodigy.net.mx
Objective:
To assess the hypnotic effect of melatonin in patients with primary insomnia.
Method:
Ten patients (mean age 50 yr, range 30-72 yr) who met the DSM-IV criteria for primary insomnia received, in random order, 0.3 mg of melatonin, 1.0 mg of melatonin or placebo 60 minutes before bedtime. A crossover design was used so that each patient received each of the 3 treatments for a 7-day period (with a 5-day washout period between). After each 7-day treatment, night time electroencephalographic (EEG) records were collected, and each morning, subjects completed sleep logs and analogue-visual scales to document the amount and subjective quality of sleep.
Results:
There were no significant differences in sleep EEG, the amount or subjective quality of sleep or side effects between the placebo, 0.3-mg melatonin or 1.0-mg melatonin treatments.
Conclusion:
Melatonin did not produce any sleep benefit in this sample of patients with primary insomnia.