FDA has announced its approval of Hetlioz, first treatment for non-24 hour sleep-wake disorder, a “chronic disruption of the internal body clock in people who are totally blind resulting in problems with the timing of sleep. This occurs because light does not penetrate their eyes and they are unable to synchronize their ciradian rhythms to the 24-hour light/dark cycle.
“Non-24- hour sleep-wake disorder can prevent blind individuals from following the normal daily schedule that we all take for granted,” explained Dr.Eric Bastings, M.D, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. "People with non-24 may find their sleep patterns reversed. They need to sleep during the day and to be awake at night. In addition, they often wake up groggy or feeling as if they need more rest. Hetlioz can improve the ability to obtain normal sleep patterns.”
The most common side effects reported by patients were headache, elevated liver enzymes in the blood, nightmares or unusual dreams, disturbed night’s sleep, upper respiratory or urinary tract infection, and drowsiness. Bastings also reported that the drug can, “impair activities that require complete mental alertness, and therefore should be taken at the same time every night before bedtime and activities should be limited after taking the drug.”
To learn more readers can contact the FDA at 888-INFO-FDA