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Sodium Oxybate as Off-label Treatment for Anxiety Disorder: Successful Outcome in a Low-energy Anxious Resistant Patient

Maremmani, Angelo G.I. MD*,†; Bacciardi, Silvia MD*; Rovai, Luca MD*; Rugani, Fabio MD*; Dell’Osso, Liliana MD*; Maremmani, Icro MD*,†,‡

Addictive Disorders & Their Treatment: December 2015 - Volume 14 - Issue 4 - p 198–202
doi: 10.1097/ADT.0000000000000055
Original Articles

Background: Sodium oxybate is a useful and approved medication for a few medical conditions (eg, narcolepsy, alcoholism), but concerns regarding its abuse make it seem like an unsafe and poor-handling drug. Contrary to illicit γ-hydroxybutyrate (GHB), sodium oxybate (SO) is a safe drug and is a promising tool in several illnesses such as fibromyalgia, essential tremor, headache, sleep disturbance, and binge-eating disorder. GHB has been demonstrated to affect the signaling of neurotransmitters/hormonal systems such as monoaminergic (including GABA, dopamine, serotonin), opioid, glutamate, and hormonal axes (also involved in the regulation of feeding behavior) within the central nervous system.

Methods: We present a case in which a Spanish patient affected by resistant anxiety disorder was successfully treated with SO after an unsuccessful treatment with benzodiazepines and antidepressants.

Case Presentation: Despite correct benzodiazepine and antidepressant prescriptions, the patient reported a low level of anxiety and energy, as well as sexual side effects and anhedonia, with a reduction in global functioning. We started with a standard treatment for anxiety disorder, but after a few months he reported little improvement in his anxiety level, permanence of side effects, and low energy level. We decided to start an off-label prescription of SO, prescribing 1.75 mg of GHB qid. The patient felt better, his mood was euthymic, and he did not present with anxiety. He reported good energy level and global functioning and observed a reduction in sexual dysfunctions and marked improvement in sleep. He was compliant with the whole procedure and timing of treatment. No problem occurred during the treatment procedure with regard to side effects and compliance to treatment.

Final Remarks: On the basis of this result SO can be a useful and promising tool in the treatment of anxiety disorder.

*“Vincent P. Dole” Dual Diagnosis Unit, Department of Neurosciences, Santa Chiara University Hospital, University of Pisa

“G. De Lisio,” Institute of Behavioral Sciences Pisa, Pisa

Association for the Application of Neuroscientific Knowledge to Social Aims (AU-CNS), Pietrasanta, Lucca, Italy

I.M. served as Board Member for Reckitt Benckiser Pharmaceuticals, Mundipharma, D&A Pharma, and Lundbeck. The other authors declare no conflict of interest.

Reprints: Angelo G.I. Maremmani, MD, “Vincent P. Dole” Dual Diagnosis Unit, UOP1, Department of Neurosciences, “Santa Chiara” University Hospital, University of Pisa, Via Roma, 67 56100 Pisa, Italy (e-mail: maremman@med.unipi.it).

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