Increased psychomotor disturbance with eszopiclone- insomnia drug

Increased psychomotor disturbance with eszopiclone- insomnia drug

                      Eszopiclone  is a sedative-hypnotic sleep medicine used to treat insomnia in adults.                            

In a double-blind study of 91 healthy adults between 25 and 40 years old, the effects of eszopiclone 3 mg on psychomotor function were assessed the following morning, between 7.5 and 11.5 hours after dosing.  Measures included tests of psychomotor coordination that are correlated with the ability to maintain a motor vehicle in the driving lane, tests of working memory, and subjective perception of sedation and coordination. It was observed that eszopiclone 3 mg was associated with next-morning psychomotor and memory impairment that was most severe at 7.5 hours but still present and potentially clinically meaningful at 11.5 hours. Eszopiclone 3 mg had an impairing effect almost as large as zopiclone 7.5 mg, a similar insomnia drug. 

Additional Information for Patients  

·         Patients who take eszopiclone and other medicines to help them sleep can experience decreased mental alertness in the morning after use, even if they feel fully awake.

·         It   can cause next-day impairment of driving and other activities that require full alertness.

·         The recommended starting dose of eszopiclone has been lowered to 1 mg from 2 mg, to be taken once each evening immediately before bedtime.  The 1 mg dose can be increased to 2 mg or 3 mg if needed, but the higher doses are more likely to impair next-day driving and other activities that require full alertness.

·         Elderly patients and patients with severe liver disease should not take doses of more than 2mg.

·         If you are currently taking the drug, continue taking your prescribed dose and contact your health care professional to ask about the most appropriate dose for you. 

·         Patients taking a 3 mg dose of drug are cautioned against driving or engaging in other activities that are hazardous or require complete mental alertness the day after use.

·         Take all insomnia medicines exactly as prescribed.

·         Over-the-counter (OTC) insomnia medicines that are available without a prescription should not be considered safer than prescription insomnia medicines for next-morning alertness and driving.

·         Report any side effects if occurred.

Additional Information for Health Care Professionals  

·         Eszopiclone can cause next-day impairment of driving and other activities that require full alertness.

·         The recommended starting dose has been lowered to 1 mg from 2 mg.  Dosing can be raised to 2 mg or 3 mg if clinically indicated.  The total dose should not exceed 3 mg, once each evening immediately before bedtime.

·         Elderly patients and patients with hepatic impairment should not be prescribed doses of more than 2 mg.

·         In some patients, the higher morning blood levels of  Eszopiclone following use of the 2 mg or 3 mg doses increase the risk of next-day impairment of driving and other activities that require full alertness.

·         Caution patients taking 3 mg of eszopiclone against driving or engaging in activities that are hazardous or require complete mental alertness the day after use.

·         For all insomnia drugs, prescribe the lowest dose necessary to treat the patient’s symptoms.

·         Inform patients that impairment from insomnia drugs can be present despite feeling fully awake.

·         Report adverse events involving eszopiclone.

Shinu.C 

Asst Prof