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

Starting date:
January 3, 2014
Posting date:
January 3, 2014
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Dosage
Audience:
Healthcare Professionals
Identification number:
RA-37415

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

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

January 3, 2014

Subject:   New dosage recommendations for Sublinox™ (zolpidem tartrate) to minimize risk of next-day impairment in both women and men

Dear Healthcare Professional,

MEDA VALEANT PHARMA CANADA INC., in consultation with Health Canada, would like to inform you of important new dosing information which has been added to the Product Monograph for Sublinox™ (zolpidem tartrate).

Sublinox™ (zolpidem tartrate) is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings.

The following points summarize the updated Product Monograph information concerning recommended dose and dosage adjustment:

  • The recommended initial dose has been revised 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 the planned time of awakening.
  • The total dose of Sublinox™ should not exceed 10 mg once daily immediately before bedtime. The lowest effective dose for the patient should be used.
  • In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness.

The recommended initial doses for women and men are different because of lower rate of clearance and higher blood levels of zolpidem in women compared to men.

Health care professionals are also reminded that in geriatric patients (≥65 years of age) clearance rate of zolpidem is lower in both men and women when compared to young adults. The recommended dose of Sublinox™ in geriatric patients is 5 mg regardless of gender.

Additionally, healthcare professionals should advise patients (men and women) who use Sublinox™ about the risk of next-day impairment for activities that require complete mental alertness, including driving. In particular, the following points should be mentioned:  

  • That this risk is increased if dosing instructions are not carefully followed;
  • Not to drive a car or engage in hazardous activities requiring complete alertness until they know how the drug affects them the next day;
  • Tell patients that if they took Sublinox™ as instructed and do not feel drowsy in the morning, they still have to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness;

A copy of the most up-to-date Sublinox™ Product Monograph can be found at: http://webprod5.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.  Any case of serious psychomotor impairment or other 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

To correct your mailing address or fax number, contact Valeant Canada.

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

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

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

Should you have any questions regarding the use of Sublinox™, please contact Valeant Canada LP at the address or telephone number listed above. We look forward to answering any questions you may have following this communication.

Sincerely,

original signed by

Dr. Maxime Barakat
Executive Director,
Medical and Regulatory Affairs
Valeant Canada LP

References: Sublinox™ approved product monograph August 27, 2013