Tasimelteon, a melatonin agonist for the treatment of insomnia and circadian rhythm sleep disorders.

Jul 7, 2009Current opinion in investigational drugs (London, England : 2000)

Tasimelteon, a melatonin-like drug for treating insomnia and sleep cycle problems

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Abstract

Tasimelteon is effective in reducing sleep onset latency and resetting the circadian melatonin rhythm.

The drug demonstrates potential for treating jet lag, shift work, and circadian rhythm sleep disorders.
Statistically significant improvements in sleep maintenance have been observed.
Preclinical evidence suggests tasimelteon may be effective for depressive disorders related to circadian dysfunction.
Tasimelteon is well tolerated, does not impair next-day functioning, and appears safe for short-term use.
Long-term safety requires further toxicological data.

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Tasimelteon, developed by Vanda Pharmaceuticals Inc under license from Bristol-Myers Squibb Co, is a melatonin receptor agonist. Because of the high density of melatonin receptors in the circadian pacemaker, the suprachiasmatic nucleus, melatonergic actions can phase-shift circadian rhythms and promote sleep. Tasimelteon was effective in reducing sleep onset latency (in phase II and III clinical trials) and in resetting the circadian melatonin rhythm (in phase II trials), which indicated its potential suitability as treatment for jet lag, shift work and circadian rhythm sleep disorders. Statistically significant improvements in sleep maintenance have also been observed with the drug. Tasimelteon has been claimed to be useful in the treatment of depression, and preclinical evidence in this respect is to be confirmed in a phase II clinical trial, which was ready to be initiated at the time of publication. It is plausible that the drug may be effective in the treatment of depressive disorders, at least those that are related to circadian dysfunction, and that it may attenuate sleep problems in depressed patients of different subtypes. A general suitability in mitigating other symptoms of major depressive disorder cannot be deduced from the actions of tasimelteon via the melatonin receptors MT1 and MT2. The drug is well tolerated, does not induce impairment of next-day functioning or dependence, and seems to be safe in short-term treatment; however, toxicological data would be required for assessing its long-term safety.

Tasimelteon, a melatonin agonist for the treatment of insomnia and circadian rhythm sleep disorders.

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