Skip to main content

Drug Alert


Jan 3, 2014: Sublinox (zolpidem tartrate) Sleep Medication- Adjusted Dosage Recommendations


Health Canada has endorsed important changes in safety information for the drug Sublinox (zolpidem tartrate), a commonly prescribed sleep medication. There are new dosage recommendations for Sublinox™ (zolpidem tartrate) come from the company Valeant Canada in order to minimize the risk of next-day impairment in both women and men.

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:
&nbsp&nbsp&nbsp&nbsp&nbsp•&nbsp&nbspThe 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.
&nbsp&nbsp&nbsp&nbsp&nbsp• &nbsp&nbspThe total dose of Sublinox™ should not exceed 10 mg once daily immediately before bedtime. The lowest effective dose for the patient should be used.
&nbsp&nbsp&nbsp&nbsp&nbsp• &nbsp&nbspIn 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.