Imovane 7.5 mg

INDICATIONS

Zopiclone 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.

PHARMACOLOGY

Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic agent. This is structurally unrelated to existing hypnotics. However, the pharmacological profile of Zopiclone is similar to that of the benzodiazepines. Zopiclone pharmacological properties are: hypnotic, sedative, anxiolytic, anti-convulsant, muscle-relaxant. These effects are related to a specific agonist action at central receptors belonging to the GABAA macromolecular complex, modulating the opening of the chloride ion channel.

DOSAGE

The recommended initial dose is 3.75 mg (one-half of a 7.5 mg tablet). The dose can be increased to 5 mg and further to 7.5 mg if clinically indicated. In some patients, the higher doses result in zopiclone blood levels in the morning high enough to produce impairment of driving and other activities that require full alertness. The 7.5 mg dose should not be exceeded.

INTERACTION

Zopiclone may produce more pronounced side effects when co- administered with:

Alcohol
Other tranquilizers or sleeping pills
Sedative antihistamines
Anticonvulsants (medicines used to control or prevent convulsions)
Narcotic analgesics (opioids)
Antipsychotics, antidepressants and other psychotropic medications (mood altering drugs) which themselves can make you sleepy.

SIDE EFFECTS

Common side effects are somnolence, dizziness, confusion, anterograde amnesia or memory impairment, feeling of drunkenness, euphoria, nightmares, agitation, anxiety or nervousness, hostility, depression, decreased libido, libido disorder, coordination abnormality, headache, hypotonia, tremor, muscle spasms, paresthesia, and speech disorder, palpitations, dysgeusia (bitter taste), dry mouth, coated tongue, bad breath, nausea, vomiting, diarrhea, constipation, anorexia or increased appetite.

PREGNANCY & LACTATION

Do no take Zopiclone at anytime during pregnancy, it may affect the developing baby. Zopiclone passes into breast milk. Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you

PRECAUTIONS & WARNINGS

Do not take more Zopiclone than prescribed.
Do not use for longer than recommended by your physician. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
Do not take Zopiclone if you drink alcohol.
Talk to your doctor if you have had episodes of sleepwalking in the past, or if there is a history of sleepwalking in your family.
Talk to your doctor if you have a condition that affects your sleep, such as Periodic Limb Movement Disorder (involuntary movement of limbs during sleep) or Restless Legs Syndrome (urge to move legs, usually accompanied by uncomfortable and unpleasant sensations, that begins or worsens during periods of inactivity, typically in the evening and night).

USE IN SPECIAL POPULATIONS

Zopiclone is not indicated for patients under 18 years of age.

THERAPEUTIC CLASS

Miscellaneous sedatives & hypnotics

STORAGE CONDITIONS

Store in a dry place, at room temperature (15°C to 30°C). Protect from light. Keep in a safe place out of reach of children.