DCSIMG
Depression and Insomnia

Insomnia & Depression

Sleep better with AMBIEN CR 2

In a clinical trial, patients with insomnia and co-morbid MDD were treated with AMBIEN CR plus an SSRI throughout 24 weeks.18

Results show 18:

  • AMBIEN CR was an effective and well-tolerated treatment for insomnia in patients who had co-morbid MDD.
  • The AMBIEN CR group treated with an SSRI had significantly greater improvement in total sleep time (TST) than the placebo/SSRI treatment group.
  • Improvement in TST was observed as early as Week 2 and at all other time points during a 24-week study in insomnia patients with co-morbid MDD who were administered AMBIEN CR and an SSRI.
SUMMARY OF INCREASED MEAN TST IN MINUTES,BY TREATMENT GROUP AND VISIT

N=380

*P<0.0001.

In a randomized, double-blind, parallel-group, placebo-controlled trial, 380 adults with insomnia comorbid with MDD were treated concomitantly with either 12.5 mg/night AMBIEN CR or placebo; all patients received open-label 10mg/day Lexapro® §. Patients received 8 weeks of treatment in phase I. Those whose depression responded to treatment (≥50 % reduction in HAM-D17) were eligible to continue with double-blind study medication in phase II for an additional 16 weeks.

§ Lexapro (escitalopram oxalate) is a registered trademark of Forest Pharmaceuticals, Inc.

Improved Sleep-Related Next-Day Function

Patients with co-morbid MDD and insomnia who took AMBIEN CR plus an SSRI showed significant improvements in sleep-related next-day function, including more morning energy and concentration.18

As measured by the Sleep Impact Scalea questionnaire, patients taking AMBIEN CR demonstrated significant improvement in the following 6 domains (beyond that of patients taking an SSRI/placebo)18:

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* Maximum benefit is $240 off, up to $20 off each prescription (up to 12 prescriptions), depending on your out-of-pocket costs. Not valid for patients participating in Medicare, Medicaid, government (public insurance) programs, or any private payor in the state of Massachusetts and where prohibited by law.

AMBIEN CR is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. AMBIEN CR is not indicated for the treatment of GAD or MDD.

Due to its rapid onset of action, patients should take AMBIEN CR right before going to bed and when ready for sleep.

IMPORTANT SAFETY INFORMATION

Patients should not take AMBIEN CR unless they are prepared to get a full night’s sleep (7 to 8 hours) to avoid residual effects. Until they know how it will affect their physical or mental performance upon awakening, patients should not drive or operate hazardous machinery after taking AMBIEN CR or any other sleep medication. Complex behaviors such as somnambulism, including driving or eating while not fully awake, with amnesia for the event, as well as abnormal behaviors such as being more outgoing or aggressive than normal, confusion, agitation, and hallucinations may occur. AMBIEN CR should not be taken with alcohol as it may increase these abnormal behaviors. Discontinuation of AMBIEN CR should be strongly considered for patients reporting such complex behaviors. Angioedema may occur in patients taking AMBIEN CR and in rare cases may be fatal. Patients who develop angioedema should not be rechallenged. In primarily depressed patients, worsening of depression, including risk of suicidal thoughts or actions, including completed suicides, have been reported. Therefore, AMBIEN CR should be administered with caution to patients exhibiting signs or symptoms of depression, in whom suicidal tendencies may be present and protective measures may be required. Intentional overdosage is more common in this group of patients; the least amount of drug that is feasible should be prescribed for the patient at any one time.The most commonly observed adverse events in controlled clinical trials were headache, somnolence, and dizziness.

Please refer to the full prescribing information.