Belbien Zolpidem 10 mg

Belbien (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

The clinical trials performed with Zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

Short term treatment of insomnia in adults.

Benzodiazepines or benzodiazepine-like agents are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.

The short-term treatment of insomnia in adults in situations where the insomnia is debilitating or is causing severe distress for the patient.

Belbien (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).

The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks i

Dosage In Adults
Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 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 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness. The total dose of Belbien should not exceed 12.5 mg once daily immediately before bedtime. Belbien should be taken as a single dose and should not be readministered 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 Belbien in these patients is 6.25 mg once daily immediately before bedtime.

Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of Belbien in these patients is 6.25 mg once daily immediately before bedtime. Avoid Belbien use in patients with severe hepatic impairment as it may contribute to encephalopathy.

Use With CNS Depressants
Dosage adjustment may be necessary when Belbien is combined with other CNS depressant drugs because of the potentially additive effects.

Administration
Belbien extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of Belbien may be slowed by ingestion with or immediately after a meal.

The dose of Belbien (zolpidem tartrate oral spray) should be individualized.

Dosage in adults
The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Belbien (zolpidem tartrate oral spray) dose should not exceed 10 mg per day.

Special populations
Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Belbien (zolpidem tartrate oral spray) in both of these patient populations is 5 mg once daily immediately before bedtime.

Use with CNS depressants
Dosage adjustment may be necessary when Belbien (zolpidem tartrate oral spray) is combined with other CNS-depressant drugs because of the potentially additive effects.

n both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration.

Belbien (zolpidem tartrate) Oral Spray is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.