Basic Drug Info
Manufacturer:MedPointe Pharmaceuticals
Other Info:

Treatment of overdosage is mainly supportive and consists of the following: Maintenance of an adequate airway, with assisted respiration and oxygen administration as necessary.

Monitoring of vital signs and fluid balance.If the patient is conscious and has not lost the gag reflex, emesis may be induced with ipecac.

Care should be taken to prevent pulmonary aspiration of vomitus.

After completion of vomiting, 30 grams activated charcoal in a glass of water may be administered.

If emesis is contraindicated, gastric lavage may be performed with a cuffed endotracheal tube in place with the patient in the face down position.

Activated charcoal may be left in the emptied stomach and a saline cathartic administered.

Fluid therapy and other standard treatment for shock, if needed.

If renal function is normal, forced diuresis may aid in the elimination of the barbiturate.

Although not recommended as a routine procedure, hemodialysis may be used in severe barbiturate intoxications or if the patient is anuric or in shock.

Appropriate nursing care, including rolling patients from side-to-side every 30 minutes, to prevent hypostatic pneumonia, decubiti, aspiration, and other complications of patients with altered states of consciousness.

Antibiotics should be given if pneumonia is suspected.

Clinical Trials:

Indications and Usage

BUTISOL SODIUM® (butabarbital sodium tablets, USP and butabarbital sodium oral solution, USP) is indicated for use as a sedative or hypnotic.

Since barbiturates appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks, use of BUTISOL SODIUM® in treating insomnia should be limited to this time (see CLINICAL PHARMACOLOGY above).
Sleeplessness -- Difficulty in going to sleep or getting enough sleep.


Barbiturates are contraindicated in patients with known barbiturate sensitivity.

Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria.
Porphyria -- group of disorders characterized by the excessive production of porphyrins or their precursors that arises from abnormalities in the regulation of the porphyrin-heme pathway; acquired porphyrias, which are due to inhibition of enzymes in the metabolic pathway by a drug, toxin or abnormal metabolite, are more common than those which are inherited.


Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient.

The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.

Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequences of an unrecognized psychiatric or physical disorder.

Such findings have emerged during the course of treatment with sedative-hypnotic drugs.

Because some of the important adverse effects of sedative-hypnotics appear to be dose related (see PRECAUTIONS and DOSAGE AND ADMINISTRATION), it is important to use the smallest possible effective dose, especially in the elderly.Complex behaviors such as “sleep driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported.

These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic-experienced persons.

Although behaviors such as sleep-driving may occur with sedative-hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviors, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose.

Due to the risk to the patient and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a “sleep driving” episode”.Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.

As with sleep-driving, patients usually do not remember these events.

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