Health Canada, Aug 30, 2006
2006-82
August 30, 2006
Advisory
For immediate release
Health Canada Advises Consumers Not To Use Dietary Supplement Due To Potential Health Risks
OTTAWA - Health Canada is advising consumers not
to use Salt Spring Herbals Sleep Well Dietary Supplement because a
sample analyzed by Health Canada has been found to contain the
undeclared drug estazolam, a sedative that can be habit-forming when
used for as little as a few months. Consumers already taking this
product should consult with a health care professional before they
stop taking the capsules, since symptoms of withdrawal are possible.
A recall has been initiated by the Canadian distributor.
Salt Spring Herbals Sleep Well Dietary Supplement capsules are
advertised as a herbal natural health product to relieve insomnia
and restless leg syndrome. The most common side-effects associated
with the use of products containing estazolam are dizziness and
drowsiness. More serious side-effects include loss of memory,
hallucinations, confusion and depression.
Drugs in the same class (benzodiazepine) as estazolam can only be
prescribed by a physician. Estazolam should not be used by people
with an allergy to other benzodiazepines (such as Valium, Restoril
and Ativan), or those affected by the neuromuscular disorder
myasthenia gravis or sleep apnea. Estazolam should be used with
caution by pregnant women, the elderly, and those with a history of
substance abuse.
Consumers who have purchased Salt Spring Herbals Sleep Well
Dietary Supplement capsules should return the product to the place
of purchase. To date, no adverse reactions suspected to be
associated with the use of this product have been reported in
Canada.
This product has been found on the Canadian market but is not
authorized for sale in Canada. The Canadian distributor, Salt Spring
Herbals in British Columbia, is recalling the product based on
preliminary findings with one package, and Health Canada is
conducting additional tests to determine the source of the
undeclared drug. Health Canada will update this advisory as more
information becomes available.
Please note that this Advisory does not apply to Nova Sleep Well,
a melatonin-containing natural health product for which Health
Canada has issued an authorization to sell (NPN 80001443) to NHP
Research and Consulting Co. of Richmond, B.C.
The text in this article was prepared by Health Canada.