Statement from sanofi-aventis, the maker of Ambien and Ambien CR:
Approximately 30 million Americans suffer from chronic insomnia, and it can seriously affect their health, work and personal relationships. Yet, insomnia remains under-recognized and under-treated by healthcare professionals. It is important for patients to talk to their healthcare professional about their insomnia so it can be properly diagnosed and treated.
As the maker of the leading prescription sleep medication, we are always very interested in learning about patient experiences with our products. We are in frequent contact with patients and healthcare professionals — answering questions, providing information, and taking other steps to assure our products are used safely, effectively and appropriately. And, we regularly inform the appropriate regulatory authorities of any adverse events.
When taken as recommended, AMBIEN and AMBIEN CR are safe and effective treatments for insomnia. Since its introduction in 1992 in the U.S., the safety and efficacy of AMBIEN has been supported by more than 15 years of real-world use.
Statement from Sepracor Inc., the maker of Lunesta:
Awareness of the seriousness and prevalence of insomnia has steadily increased in recent years as a result of reports from both The National Institutes of Health and the Institute of Medicine. This has resulted in the introduction of new therapies (medication and behavioral) to help people with insomnia.
Sepracor is actively engaged in educating patients and physicians on the importance of treating insomnia (including non-medicinal approaches), but we do not encourage the inappropriate use of sleep medicines. Insomnia is an established medical condition that has a significant and unremitting negative impact on quality of life for many patients. What may not be well appreciated outside the medical and patient communities is that insomnia is very often a chronic condition that may co-exist with other serious medical conditions. Proper treatment of insomnia may be especially important in these situations. For patients with insomnia, the best treatment approach may in fact be a safe and effective prescription medication combined with good sleep habits. It is the physician who is best equipped to make that determination.
It is also important to note that not all sleep medications are the same. Medications vary in their effectiveness in treating each of the symptoms of insomnia, just as they differ in their side effect profiles, potential for risk of dependence or abuse and even their potential to lose effectiveness over time.
The safety and efficacy of LUNESTA (eszopiclone) have been extensively studied and established in well-controlled clinical trials of thousands of patients. LUNESTA is FDA-approved to help patients fall asleep and stay asleep through the night. LUNESTA is also approved for long-term use for those patients whose insomnia does not resolve with short-term treatment. Following FDA approval, we have continued to study LUNESTA in patients having insomnia and insomnia with co-existing conditions. Extensive data exists on the safety and efficacy of LUNESTA in the treatment of insomnia.
We continue to advise patients to consult their doctor if their insomnia does not resolve within seven to 10 days to determine if their insomnia is caused by another medical condition that requires specific treatment. In our pre-approval and post-approval clinical trials, most patients experienced no next-day effects following treatment with LUNESTA, and the medication was well tolerated. These studies also demonstrated that LUNESTA continued to work for patients at the same dose when used over a long period of time (six months), with a low risk of dependence or withdrawal effects.
Our promotional materials reflect these findings with LUNESTA and appropriately convey the potential risks and side effects that a patient may experience. Again, physicians are the best judges of the appropriateness of any course of medical treatment for their patients and are best able to determine if a medication’s benefits to their patient outweigh the potential risks.