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Sublinox (zolpidem tartrate) - New Dosage Recommendations to Minimize Risk of Next-Day Impairment in Both Women and Men - For the Public

Starting date: January 3, 2014 Posting date: January 3, 2014 Type of communication: Public Communication Subcategory: Drugs Source of recall: Health Canada Issue: Dosage Audience: General Public Identification number: RA-37417

This is duplicated text of a letter from Valeant Canada. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on Sublinox (zolpidem tartrate)

January 3, 2014

Subject: New dosing instructions to minimize risk of next-day impairment after use of Sublinox™ (zolpidem tartrate) in women and men

MEDA VALEANT PHARMA CANADA INC., in consultation with Health Canada, would like to inform you of important new dosing instructions related to Sublinox™ (zolpidem tartrate).

Sublinox™ is a medicine used in adults as a sleep aid. The new dosing instructions are as follows:

The recommended initial dose has been lowered to 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before awakening.

On the morning after use, higher dose of zolpidem can increase drowsiness, reduce alertness and impair driving.

Women eliminate the drug slower than men and are more susceptible to this risk.

The recommended dose for elderly patients (65 years of age or older) is 5 mg, regardless of gender.

Follow your doctor’s advice on how to take Sublinox™, when to take it, and how long to take it. As with all hypnotics, long term use of Sublinox™ is not recommended, and the lowest effective dose should be used in consultation with your doctor. Sublinox™ should be taken right before going into bed. Do not take Sublinox™ in the middle of the night or at any time other than at bedtime.

You should not drive a car or engage in hazardous activities requiring complete alertness until you experience how the drug affects you the next day.

Discuss any questions or concerns you may have about Sublinox™ with your healthcare professional.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Any case of serious or unexpected adverse reactions in patients receiving Sublinox™ should be reported to Valeant Canada or Health Canada.

Valeant Canada

2150 St-Élzear Blvd. West, Laval

Québec, H7L 4A8

Tel. 1-800-361-4261

You can report any suspected side effect associated with the use of health products to Health Canada by:

Calling toll-free at 1-866-234-2345; or

Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

The information provided will help you in making the right decision in consultation with your health care professional.

If you would like more information you can call the medical information line at 1-800-361-4261.

Sincerely,

original signed by

Dr. Maxime Barakat

Executive Director,

Medical and Regulatory Affairs

Valeant Canada LP