"The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder ("non-24") in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorde"...
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 (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-na´ve 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 (secobarbital sodium capsules) may be habit-forming. Tolerance and psychological and physical dependence may occur with continued use (see Drug Abuse and Dependence and Pharmacokinetics under CLINICAL PHARMACOLOGY). 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 (see Drug Abuse and Dependence).
- 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
Withdrawal symptoms occur in infants born to women who receive barbiturates throughout the last trimester of pregnancy (see Drug Abuse and Dependence). If Seconal Sodium (secobarbital sodium capsules) 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.
Barbiturates may be habit-forming. Tolerance and psychological and physical dependence may occur with continuing use (see Drug Abuse and Dependence). Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or have a history of drug abuse.
Elderly or debilitated patients may react to barbiturates with marked excitement, depression, or confusion. In some persons, especially pediatric patients, barbiturates repeatedly produce excitement rather than depression.
In patients with hepatic damage, barbiturates should be administered with caution and initially in reduced doses. Barbiturates should not be administered to patients showing the premonitory signs of hepatic coma.
Information for Patients
“Sleep-Driving” and other complex behaviors
There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other central nervous system depressants (see WARNINGS). 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.
The following information should be given to patients receiving Seconal Sodium (secobarbital sodium capsules) :
- The use of Seconal Sodium (secobarbital sodium capsules) carries with it an associated risk of psychological and/or physical dependence. The patient should be warned against increasing the dose of the drug without consulting a physician.
- Seconal Sodium (secobarbital sodium capsules) may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly.
- Alcohol should not be consumed while taking Seconal Sodium (secobarbital sodium capsules) . The concurrent use of Seconal Sodium (secobarbital sodium capsules) with other CNS depressants (eg, alcohol, narcotics, tranquilizers, and antihistamines) may result in additional CNS-depressant effects.
Prolonged therapy with barbiturates should be accompanied by periodic laboratory evaluation of organic systems, including hematopoietic, renal, and hepatic systems (see General under PRECAUTIONS and ADVERSE REACTIONS).
- Animal Data. Phenobarbital sodium is carcinogenic in mice and rats after lifetime administration. In mice, it produced benign and malignant liver cell tumors. In rats, benign liver cell tumors were observed very late in life.
- Human Data—In a 29-year epidemiologic study of 9,136 patients who were treated on an anticonvulsant protocol that included phenobarbital, results indicated a higher than normal incidence of hepatic carcinoma. Previously, some of these patients had been treated with thorotrast, a drug that is known to produce hepatic carcinomas. Thus, this study did not provide sufficient evidence that phenobarbital sodium is carcinogenic in humans.
A retrospective study of 84 pediatric patients with brain tumors matched to 73 normal controls and 78 cancer controls (malignant disease other than brain tumors) suggested an association between exposure to barbiturates prenatally and an increased incidence of brain tumors.
Usage in Pregnancy
- Teratogenic Effects. Pregnancy Category D. See Usage in Pregnancy under WARNINGS.
- Nonteratogenic Effects. Reports of infants suffering from long-term barbiturate exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days (see Drug Abuse and Dependence).
Labor and Delivery
Hypnotic doses of barbiturates do not appear to impair uterine activity significantly during labor. Full anesthetic doses of barbiturates decrease the force and frequency of uterine contractions. Administration of sedative-hypnotic barbiturates to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects of barbiturates. If barbiturates are used during labor and delivery, resuscitation equipment should be available.
Data are not available to evaluate the effect of barbiturates when forceps delivery or other intervention is necessary or to determine the effect of barbiturates on the later growth, development, and functional maturity of the pediatric patient.
Caution should be exercised when Seconal Sodium (secobarbital sodium capsules) is administered to a nursing woman, because small amounts of barbiturates are excreted in the milk.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/21/2009
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