Part 5 – Research in progress: melatonin-like medications
The recognition that melatonin can shift the timing of inner clocks has triggered efforts to develop melatonin-like medications.
“These medications potentially may prove as good as, or even more effective than melatonin, and could be regulated, prescribed, controlled, and monitored for safety,” said Harvard neuroscientist Steven Lockley.
In 2005, the FDA approved a melatonin-like medication, ramelteon, for the treatment of insomnia characterized by difficulty falling asleep. Researchers report it helped insomniacs fall asleep faster and stay asleep longer, without experiencing a daytime hangover or grogginess, or prompting dependence on its use. The National Library of Medicine provides information on this medication at http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000321/.
In 2010, the FDA granted orphan drug status to another melatonin-like investigational medication, tasimelteon, for use in totally blind adults with N24HSWD. FDA gives orphan drug status to drugs developed specifically to treat rare medical conditions.
A randomized clinical trial now underway will assess the safety and efficacy of tasimelteon in increasing total nighttime sleep time in totally blind adults with N24HSWD. In this trial, researchers will compare tasimelteon with a placebo, that is, a look-alike but inactive pill, over a six month study period.
The study is being conducted at 25 medical centers in the US and six in Germany. It is sponsored by Vanda Pharmaceuticals. Researchers hope to enroll a total of 100 participants: 50 in the active medication group, and 50 in the placebo group.
More information about sleep and sleep disorders is available at:
The National Institutes of Health:
The National Sleep Foundation:
The American Academy of Sleep Medicine:
An important reminder: Poor sleep always warrants a discussion with your primary care physician. Keep a sleep diary for at least two weeks before the visit to give your doctor a better understanding of how you sleep.
Record when you go to sleep and get up, and the time of daytime naps. Note use of caffeine, alcohol, and other medications.
Your doctor may refer you to a sleep disorders center. Sleep specialists can assess your melatonin secretion pattern, suggest treatment strategies to improve both sleep and daytime alertness, and tell you about research studies in progress in which you may wish to participate.
This series was written by medical journalist Lynne Lamberg, co-author of The Body Clock Guide to Better Health, http://bodyclockguide.com/. Lamberg writes widely on sleep medicine and biological clocks for physicians and the general public.