Secobarbital sodium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]
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Overview
Secobarbital sodium is a Barbiturate that is FDA approved for the treatment of Insomnia and as Preanesthetic. Common adverse reactions include somnolence.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Dosages of barbiturates must be individualized with full knowledge of their particular characteristics. Factors of consideration are the patient's age, weight, and condition.
Insomnia
100 mg at bedtime.
- For the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks.
Preanesthetic
Preoperatively, 200 to 300 mg, 1 to 2 hours before surgery.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Secobarbital sodium in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Secobarbital sodium in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Preanesthetic
Preoperatively, 2 to 6 mg/kg, with a maximum dosage of 100 mg.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Secobarbital sodium in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Secobarbital sodium in pediatric patients.
Contraindications
- Hypersensitive to barbiturates.
- Patients with a history of manifest or latent porphyria,
- Marked impairment of liver function
- Marked impairment respiratory disease in which dyspnea or obstruction is evident.
Warnings
- 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 consequence 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, 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-naïve 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.
Habit-Forming
- Seconal Sodium may be habit-forming.
- Tolerance and psychological and physical dependence may occur with continued use.
- Patients who have psychological dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and subsequently may develop a physical dependence on barbiturates. To minimize the possibility of overdosage or development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment.
- The abrupt cessation after prolonged use in a person who is dependent on the drug may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive doses over long periods of time.
Acute or Chronic Pain
- Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked.
Usage in Pregnancy
- Barbiturates can cause fetal harm when administered to a pregnant woman. *Retrospective, case-controlled studies have suggested that there may be a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities.
- Barbiturates readily cross the placental barrier and are distributed throughout fetal tissues; the highest concentrations are found in the placenta, fetal liver, and brain.
- Fetal blood levels approach maternal blood levels following parenteral administration.
- Withdrawal symptoms occur in infants born to women who receive barbiturates throughout the last trimester of pregnancy.
- If Seconal Sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Synergistic Effects
- The concomitant use of alcohol or other CNS depressants may produce additive CNS-depressant effects.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Secobarbital sodium Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Secobarbital sodium Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Secobarbital sodium Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Barbiturates can cause fetal harm when administered to a pregnant woman. Retrospective, case-controlled studies have suggested that there may be a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Barbiturates readily cross the placental barrier and are distributed throughout fetal tissues; the highest concentrations are found in the placenta, fetal liver, and brain. Fetal blood levels approach maternal blood levels following parenteral administration.
Withdrawal symptoms occur in infants born to women who receive barbiturates throughout the last trimester of pregnancy. If Seconal Sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Secobarbital sodium in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Secobarbital sodium during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Secobarbital sodium in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Secobarbital sodium in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Secobarbital sodium in geriatric settings.
Gender
There is no FDA guidance on the use of Secobarbital sodium with respect to specific gender populations.
Race
There is no FDA guidance on the use of Secobarbital sodium with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Secobarbital sodium in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Secobarbital sodium in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Secobarbital sodium in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Secobarbital sodium in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Secobarbital sodium Administration in the drug label.
Monitoring
There is limited information regarding Secobarbital sodium Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Secobarbital sodium and IV administrations.
Overdosage
There is limited information regarding Secobarbital sodium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Secobarbital sodium Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Secobarbital sodium Mechanism of Action in the drug label.
Structure
There is limited information regarding Secobarbital sodium Structure in the drug label.
Pharmacodynamics
There is limited information regarding Secobarbital sodium Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Secobarbital sodium Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Secobarbital sodium Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Secobarbital sodium Clinical Studies in the drug label.
How Supplied
There is limited information regarding Secobarbital sodium How Supplied in the drug label.
Storage
There is limited information regarding Secobarbital sodium Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Secobarbital sodium Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Secobarbital sodium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Secobarbital sodium Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Secobarbital sodium Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.