Sonata is the brand name for a newer type of prescription sleep aid called zaleplon. Zaleplon is a hypnotic, meaning that it works on specific areas of the brain to help relax the patient. By feeling more relaxed, the patient is then able to fall asleep. Sonata, or zaleplon, is a newer sleep aid medication that is prescribed to patients who have trouble falling asleep. Sonata is not prescribed to patients who have trouble staying asleep.
Sonata was approved by the U.S. Food and Drug Administration (FDA) in 1999 as a non-benzodiazepine prescription medication used to treat insomnia. Patients are typically prescribed between 5mg and 20mg doses, and they are told to take Sonata right before going to bed. If a patient takes Sonata too early, the patient may still experience unrestful sleep, dizziness, drowsiness, or memory loss. In addition, patients must only take Sonata when they plan to get a full night of sleep. If a patient takes Sonata and sleeps less than 4 hours, the risk of memory loss, dizziness, or drowsiness is increased.
There has been an increasing amount of debate over which types of sleep aids are safest and most effective. Patients are also questioning whether “non-habit forming” sleep aids are actually less addictive than older sleep medications. According to Consumer Reports, new sleep medications such as Sonata are still highly addictive, without being any safer or more effective than older medications.
Using Sonata places patients at risk of the following:
- Anaphylaxis, or severe allergic reaction
- Angioedema, or severe facial swelling
- Daytime drowsiness
- Memory loss, or lapse in memory
- Unsteadiness, or loss of coordination
- Sleep walking, sleep eating, sleep driving, and other odd behaviors such as making phone calls or having sex and not remembering
- Rebound insomnia, whenever the patients stops using Sonata
- Development of certain cancers
Sonata FDA Warning
In 2007, the FDA requested that all sedative-hypnotic manufacturers expand their sleep aid warning labels. The expanded sleep aid warning labels, for drugs such as Sonata, were to include warnings regarding severe allergic reactions and facial swelling. Allergic reactions and facial swelling from sleep aid medication are particularly dangerous because the patient may struggle to breathe.
The FDA’s sleep aid warnings also required sedative-hypnotic manufacturers to include behavioral information on their sleep aid warning labels. Complex behaviors can occur as the result of taking a sleep aid. This includes sleep driving, sleep eating, and sleep walking. In elderly patients, odd behavioral activity is likely to result in a serious fall and unexpected death.
Elderly Hip Fractures
In a recent study, researchers from Harvard Medical School analyzed the effect of insomnia and prescription sleep aid medications on memory, balance, and other cognitive capabilities of elderly patients. The researchers focus on non-benzodiazepine sleep aids, such as Sonata. To do this, the Harvard researchers used medical records from assisted living facilities and nursing homes.
The findings were published in the JAMA Internal Medicine medical journal. According to the study, using non-benzodiazepine sleep aids, such as Sonata, increased the likelihood of hip fracture in elderly patients by 66 percent. The newest users, who had just started using non-benzodiazepine sleep medication such as Sonata, were the most likely to suffer a fall and a hip fracture.
Sleeping Pill Death
Other studies have shown a link between sleep aid use and unexpected sleeping pill death. One study indicated that prescription sleep aids quadrupled the likelihood of premature, sudden death in patients. In another recent study, patients who took sleeping aids such as Sonata were found to have a 35-percent increased risk of cancer.
Sleep Aids Linked to Cancer
Types of cancer that were linked to sleep aid use, such as Sonata, include:
- Prostate cancer
- Lung cancer
- Colon cancer
Sonata Consumer Reports
Consumer Reports did a study on Sonata, and other non-benzodiazepine sleep aids, to evaluate the risks, expenses, and effectiveness of these sleep medications. According to consumer reports, newer prescription sleep aids such as Sonata were not safer or more effective than older sleep aid medications. Furthermore, new medications such as Sonata presented less long-term information and cost more money for patients to use.
Consumer Reports concluded that the best method for addressing insomnia was through psychotherapy. Consumer Reports noted the benefits of short-term sleep aid use, such as Sonata, in very severe cases of insomnia. However, Consumer Reports cautioned against long-term use of Sonata and other non-benzodiazepine sleep aids. The Consumer Reports study was conducted in January 2012.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.