Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Insomnia
Treatment: Brand Ambien (zolpidem) 10mg #2 tablets Per Day
The insurer denied the Brand Ambien (zolpidem) 10mg #2 tablets Per Day
The denial is overturned.

The patient is a adult female. She is diagnosed with a sleep disorder, primary or idiopathic chronic insomnia. The patient has comorbid psychiatric disorders: major depressive disorder and generalized anxiety disorder. The patient has been prescribed Brand Ambien 10 mg (milligrams) tablet with two tablets daily at bedtime in order to address her sleep disturbance. The patient and patient's prescribing physician report a satisfactory response to this regimen of Ambien for 10 years with tolerability and effectiveness with regard to the insomnia.

The patient has failed to benefit from multiple medications that include formulary agents: generic Ambien or zolpidem (Ambien), Sonata or zaleplon, and eszopiclone (Lunesta) all at clinically therapeutic dosages, as well as trazodone that were not effective and/or tolerated due to adverse effects. Additionally, a lower dose of Ambien at 10 mg (milligrams) per day is not effective.

The patient's clinician has prescribed Ambien at 20 mg (milligrams) daily resulting in "good sleep" with tolerability. The prescribing physician is requesting coverage for treatment with Brand Ambien at the dosage of 20 mg (milligrams) daily or sixty 10 mg (milligrams) tabs targeting symptoms of sleep disturbance/insomnia in keeping with an FDA (United States Food and Drug Administration) indication and individualized dosing strategy. The patient was previously treated with three of the formulary alternatives that include eszopiclone, zaleplon and generic zolpidem, as well as trazodone and several miscellaneous over-the-counter agents without benefit.

Yes, the treatment with Brand Ambien is medically necessary for this patient.
The requested service is in keeping with prevailing standards of medical practice for the condition under treatment in this case with an approved and evidence-base treatment. The requested services/treatment with Brand Ambien at an individualized dosage of 20 mg (milligrams) per day is clinically appropriate, and backed by credible scientific evidence known to benefit patients with the insomnia diagnosed in this case. Moreover, to reduce a dosage that has been effective and well-tolerated for up to ten years would be detrimental to the patient, as asserted by the patient and patient's prescribing physician and with a reasonable degree of medical certainty.

The requested medication in this case is being administered in accordance with the FDA (United States Food and Drug Administration) indications for insomnia. There is medical and scientific literature and the treatment with Ambien is an evidence-based treatment in this case scenario. Moreover, the patient has failed to benefit from several other hypnotic agents as well as trazodone that supports the use of Ambien at a dosage that is known to benefit this patient with insomnia. Additionally, clinical practice guidelines strongly support the administration of the requested medication for this patient's condition, and the use of Ambien 20 mg (milligrams) is as an accepted standard of practice in the United States.

Prevailing standards of professional practice as well as scientific literature and practice guidelines do strongly support the administration of Ambien for both short-term and chronic insomnia, especially in cases of primary or secondary insomnia in patients with co-occurring psychiatric disorders and/or co-morbid general medical conditions associated with sleep disturbance/insomnia. In this case, the patient has been in treatment with Brand Ambien at the current dosage with a satisfactory clinical response; and stopping the requested Ambien at the current dosage would be detrimental and likely cause rebound insomnia and could cause other complications, as the clinician argues in the appeal. Thus, medical necessity is met with regard to prevailing standards of medical practice and medical necessity in keeping with New York State instruction for this medical necessity review.

The use of Brand Ambien in this case is reasonable and in the best interest of the patient and is provided with sound medical judgment in keeping with an FDA (United States Food and Drug Administration) approved indication and with individualized dosing that has been effective for several years without adverse effect or complications. The continued use of Brand Ambien at the effective dose of 20 mg (milligrams) daily meets medical necessity in keeping with New York State instruction for this review despite the plan's assertion and application of guidelines that invoke quantity limits to 30 tabs versus 60 tabs for a 30-day time frame.

The patient has failed to benefit from multiple medications that include formulary agents: generic Ambien or zolpidem (Ambien), Sonata or zaleplon, and eszopiclone (Lunesta) all at clinically therapeutic dosages, as well as trazodone that were not effective and/or tolerated due to adverse effects. Additionally, a lower dose of Ambien at 10 mg (milligrams) per day is not effective.

Thus, coverage should be provided for the requested benefit of Brand Ambien (zolpidem) 10 mg (milligrams) Tablets dosed at 20 mg (milligrams) or two tabs daily by mouth with 60 tabs for 30 days for a period of 12 months, as the insomnia is chronic, and the patient will require continued maintenance treatment with this medication.