Paladin Labs has launched Silenor (doxepin hydrochloride), specified for the treatment and symptomatic relief of insomnia with characteristics of frequent nocturnal awakening and/or early morning awakenings, in Canada.
Silenor, which is not a controlled substance, will be made available in 3mg or 6mg oral tablets.
Paladin interim president and chief executive officer Mark Beaudet said, "Canadians who suffer from insomnia now have a new effective treatment option that is not associated with a risk of abuse or physical dependence."
Various clinical studies demonstrated significant sleep maintenance improvements with Silenor that do not produce tolerance or physical dependence.
In June 2011, Paladin obtained commercialization rights to Silenor in Canada, South America and Africa from Somaxon Pharmaceuticals, which was acquired by Pernix Therapeutic in March 2013.