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Label Changes for Prescription Sleep Aids Announced in Canada

Oct 8, 2009 | Parker Waichman LLP

Health Canada has announced label updates for several medications used in the short-term treatment of insomnia. The prescription sleep aids subject to the label revision include:  

  •     Dalmane, Som Pam (flurazepam)
  •     Mogadon, Nitrazadon (nitrazepam)
  •     Restoril (temazepam)
  •     Apo-Triazo (triazolam)
  •     Imovane, Rhovane (zopiclone)


According to the Health Canada announcement, the new labeling describes reports of complex sleep-related behaviors that have occurred while patients using these drugs were not fully awake, such as talking, walking, cooking, eating, and driving. Patients typically did not remember these events afterwards.  

The new labeling also emphasizes the proper use of these medications. In particular, sleep aid medications (also called sedative-hypnotic medications) should not be taken with alcohol, and patients should not take more than the prescribed dose. Caution should be used when taking sleep aid medications at the same time as other drugs that can cause drowsiness, such as other tranquilizers or sleeping pills, antihistamines that cause drowsiness, anticonvulsants, painkillers that contain narcotics, and medicines used to treat depression or anxiety.

Patients and people close to them are encouraged to be aware of these types of sleep-related behaviors. Patients should report any suspected events to their health care professional. Discontinuing sleep aid medication should be considered for patients who report complex sleep-related behaviors, due to the risk of harm to the patient and to others. These medications should only be discontinued by an individual after consulting with their health care professional, as abrupt discontinuation may cause symptoms of withdrawal.

The drugs affected by this label revision are used for short-term treatment of insomnia characterized by difficulty in falling asleep, or waking up often during the night or in the early morning hours. Health Canada has advised that patients typically not take sleep aid drugs for more than 7 to 10 days in a row. Any patient who has concerns or questions about the use of sleep-aid drugs should talk to their health care professional.


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