Indications And Usage

Dreamex is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Administration

Dosage in Adults:

Use Dreamex the lowest effective dose for the patient. The recommended initial dose is 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. If the 5 mg dose is not effective, the dose can be increased to 10 mg. 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 total dose of Dreamex should not exceed 10 mg once daily immediately before bedtime.

Dreamex should be taken as a single dose and should not be re administered during the same night.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

Special Populations:

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of Dreamex in these patients is 5 mg once daily immediately before bedtime.

Administration:

The effect of AMBIEN may be slowed by ingestion with or immediately after a meal.

Contraindications

Dreamex is contraindicated in patients:

who have experienced complex sleep behaviors after taking Dreamex.

with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema.

Precautions

Complex Sleep Behaviors, CNS-Depressant Effects and Next-Day Impairment, Need to Evaluate for Comorbid Diagnoses, Severe Anaphylactic and Anaphylactoid Reactions, Abnormal Thinking and Behavioral Changes, Use in Patients with Depression, Respiratory Depression, Precipitation of Hepatic Encephalopathy, Withdrawal Effects

Adverse Reactions

Complex Sleep Behaviors , CNS-Depressant Effects and Next-Day Impairment, Serious Anaphylactic and Anaphylactoid Reactions, Abnormal Thinking and Behavior Changes, Withdrawal Effects

Pregnancy and lactation

Pregnancy Category C

Renal and liver Impairment

The recommended dose of Dreamex. in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime. Avoid Dreamex. use in patients with severe hepatic impairment as it may contribute to encephalopathy

Laboratory Tests